Trial Outcomes & Findings for High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis (NCT NCT00983983)
NCT ID: NCT00983983
Last Updated: 2015-02-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
5 months
Results posted on
2015-02-27
Participant Flow
4 participants were screened but excluded due to not meeting inclusion criteria (1 due to history of Myocardial Infarction, 1 due to Diabetes, 1 due to low forced vital capacity, and 1 due to the investigator's judgment).
Participant milestones
| Measure |
High Fat/High Calorie
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
7
|
|
Overall Study
COMPLETED
|
6
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
Baseline characteristics by cohort
| Measure |
High Fat/High Calorie
n=8 Participants
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=9 Participants
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=7 Participants
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 6.9 • n=93 Participants
|
57.5 years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
63.2 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
61.3 years
STANDARD_DEVIATION 11.4 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
|
30.7 units on a scale
STANDARD_DEVIATION 7.0 • n=93 Participants
|
25.5 units on a scale
STANDARD_DEVIATION 9.4 • n=4 Participants
|
23.0 units on a scale
STANDARD_DEVIATION 3.5 • n=27 Participants
|
26.3 units on a scale
STANDARD_DEVIATION 7.6 • n=483 Participants
|
PRIMARY outcome
Timeframe: 5 monthsOutcome measures
| Measure |
High Fat/High Calorie
n=8 Participants
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=9 Participants
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=7 Participants
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Safety Outcomes: Frequency of Adverse Events
|
49 Total Number of Adverse Events
|
24 Total Number of Adverse Events
|
42 Total Number of Adverse Events
|
PRIMARY outcome
Timeframe: 5 monthsSAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
High Fat/High Calorie
n=8 Participants
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=9 Participants
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=7 Participants
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Serious Adverse Events
|
3 Number of Serious Adverse Events
|
0 Number of Serious Adverse Events
|
9 Number of Serious Adverse Events
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).
Number of participants who completed the study on their assigned study intervention.
Outcome measures
| Measure |
High Fat/High Calorie
n=6 Participants
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=8 Participants
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=6 Participants
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Tolerability
|
5 participants
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Over 5 monthsRate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.
Outcome measures
| Measure |
High Fat/High Calorie
n=6 Participants
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=8 Participants
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=6 Participants
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Rate of Change in ALSFRS-R in Units/Month
|
-1.54 units on a scale/month
Interval -2.36 to -0.73
|
-1.07 units on a scale/month
Interval -1.71 to -0.42
|
-2.17 units on a scale/month
Interval -3.24 to -1.1
|
SECONDARY outcome
Timeframe: 5 months follow-upOutcome measures
Outcome data not reported
Adverse Events
High Fat/High Calorie
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
High Calorie/High Carbohydrate
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Fat/High Calorie
n=6 participants at risk
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=8 participants at risk
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=6 participants at risk
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
2/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
50.0%
3/6 • Number of events 4 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Infection-Lung
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
Other adverse events
| Measure |
High Fat/High Calorie
n=6 participants at risk
High fat/high calorie diet: Oxepa
Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
High Calorie/High Carbohydrate
n=8 participants at risk
High calorie diet: Jevity 1.5
Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
Control
n=6 participants at risk
Control diet: Jevity 1.0
Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
|
|---|---|---|---|
|
Immune system disorders
Allergic Rhinitis
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Cardiac disorders
Elevated Troponin
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
33.3%
2/6 • Number of events 4 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
General disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
General disorders
Weight Loss
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 4 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Number of events 5 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
50.0%
3/6 • Number of events 3 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Bloating/Flatulence
|
16.7%
1/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
50.0%
3/6 • Number of events 3 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Detached feeding tube/Replacement of feeding tube
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Heartburn
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
25.0%
2/8 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Infection-Urinary Tract
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
33.3%
2/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Infection-Bronchus
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 3 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Pain-Abdomen
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea-Shortness of Breath
|
33.3%
2/6 • Number of events 4 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Respiratory, thoracic and mediastinal disorders
Cough/Congestion
|
16.7%
1/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion (non-malignant)
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Head Cold/Sinusitis
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Sore Throat
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Renal and urinary disorders
Blocked Foley Catheter
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Blood and lymphatic system disorders
"Right arm and leg puffiness"
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
General disorders
Weight Gain
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Drooling
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
General disorders
Dry Mouth
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Esophagitis/Esophageal Spasm
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Burping
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Borborygmi
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Increased Bowel Movements
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Abdominal Fullness
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Upset Stomach
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
General disorders
Protein-Calorie Malnutrition
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Infection-Lung (Pneumonia)
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
33.3%
2/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Oral/Perioral Infection
|
33.3%
2/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Infections and infestations
Cellulitis
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
C. difficile Infection
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Nervous system disorders
Extremity Weakness
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Nervous system disorders
Weakness-Trunk
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Musculoskeletal and connective tissue disorders
Neck Muscle Soreness
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/8 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Pain-Abdomen/Stomach
|
33.3%
2/6 • Number of events 2 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
16.7%
1/6 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
|
Gastrointestinal disorders
Pain at PEG site
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
12.5%
1/8 • Number of events 1 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
0.00%
0/6 • Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place