Trial Outcomes & Findings for Nuts and Oil Pilot Study (NCT NCT04361617)
NCT ID: NCT04361617
Last Updated: 2023-09-18
Results Overview
To characterize the relationship between MetS and epigenetic aging, we will examine epigenetic age acceleration prevalence among the 50 participants with metabolic syndrome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
In-person 1 day assessment visit
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
Epigenetic Age Knowledge Arm
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Epigenetic Age Knowledge Arm
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Nuts and Oil Pilot Study
Baseline characteristics by cohort
| Measure |
Epigenetic Age Knowledge Arm
n=17 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=17 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11 • n=5 Participants
|
70 years
STANDARD_DEVIATION 8 • n=7 Participants
|
68 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: In-person 1 day assessment visitPopulation: 3 samples failed DNAm QC analyses - 1 sample failed QC analyses
To characterize the relationship between MetS and epigenetic aging, we will examine epigenetic age acceleration prevalence among the 50 participants with metabolic syndrome.
Outcome measures
| Measure |
Epigenetic Age Knowledge Arm
n=14 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=15 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Proportion of Participants With MetS With Epigenetic Age Acceleration
|
0.21 proportion of participants AgeAccelGrim>
|
0.53 proportion of participants AgeAccelGrim>
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 3 samples failed DNAm QC analyses - 1 sample failed QC analyses
Adherence for each participant will be measured as the proportion of days in 4 weeks for which EVOO was taken
Outcome measures
| Measure |
Epigenetic Age Knowledge Arm
n=14 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=15 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Proportion of Days for Which EVOO Was Taken
|
0.96 proportion of days
Standard Deviation 0.08
|
0.97 proportion of days
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 3 samples failed DNAm QC analyses - 1 sample failed QC analyses
Adherence for each participant will be measured as the proportion of days in 4 weeks for which nuts were taken
Outcome measures
| Measure |
Epigenetic Age Knowledge Arm
n=14 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=15 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Proportion of Days for Which Nuts Were Taken
|
0.997 proportion of days
Standard Deviation 0.010
|
0.997 proportion of days
Standard Deviation 0.041
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 3 samples failed to generate DNAm data passing QC analyses 1 sample failed to generate DNAm data passing QC analyses
Adherence for each participant will be measured as the proportion of days in 4 weeks for which both nuts and of EVOO were taken
Outcome measures
| Measure |
Epigenetic Age Knowledge Arm
n=14 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=15 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Proportion of Days for Which Nuts and EVOO Were Taken
|
0.948 proportion of days
Standard Deviation 0.076
|
0.967 proportion of days
Standard Deviation 0.041
|
PRIMARY outcome
Timeframe: After 4-week interventionPopulation: % that would be able to continue eating the tree nuts and EVOO for a study like this lasting 3-4 years
Qualitative interview with open-ended questions designed to ascertain participant understanding of epigenetic age, and assess the challenges and motivators participants encountered during the intervention. Will be assessed using qualitative analysis methods.
Outcome measures
| Measure |
Epigenetic Age Knowledge Arm
n=17 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=15 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Percentage of Participants Would be Able to Continue Eating the Tree Nuts and EVOO for a Study Like This Lasting 3-4 Years
|
76 Percentage of Participants
|
93 Percentage of Participants
|
SECONDARY outcome
Timeframe: In-person 1 day assessment visit vs. final 1 day visit after 4-week interventionPopulation: 3 samples failed to generate DNAm data passing QC analyses - 1 sample failed to generate DNAm data passing QC analyses
The investigators will compare epigenetic age acceleration before and after the 4-week intervention via DNA methylation test.DNA methylation profiles (beta-value, after adjustment chip and position effects) at 1,030 unique DNA methylation profiles will be used for epigenetic age acceleration predictions, using the DNA GrimAge predictor. The investigators will calculate predicted lifespan and regress predicted lifespan on chronological age to produce estimates of epigenetic age acceleration.
Outcome measures
| Measure |
Epigenetic Age Knowledge Arm
n=14 Participants
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=15 Participants
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Changes in Epigenetic Age Acceleration
|
-0.2 AgeAccelGrim (years)
Standard Deviation 1.4
|
0.1 AgeAccelGrim (years)
Standard Deviation 1.3
|
Adverse Events
Epigenetic Age Knowledge Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Epigenetic Age Knowledge Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epigenetic Age Knowledge Arm
n=17 participants at risk
Half of the intervention participants will be randomly selected to be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
No Epigenetic Age Knowledge Arm
n=17 participants at risk
The other half of intervention participants will not be informed of epigenetic age before the intervention.
Daily consumption of tree nuts and extra virgin olive oil: All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • Number of events 3 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
11.8%
2/17 • Number of events 3 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Infections and infestations
Pruritus
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Endocrine disorders
Weight Gain
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Indigestion
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Upset Stomach
|
11.8%
2/17 • Number of events 2 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
bloating or increased bloating
|
5.9%
1/17 • Number of events 5 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Increased stool frequency
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Metabolism and nutrition disorders
Loose Bowel movement
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Gas/Belching
|
5.9%
1/17 • Number of events 3 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Eye disorders
Stye in eye
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Skin and subcutaneous tissue disorders
Sinus HA with nose bleed
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Stomach bug with diarrhea
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Musculoskeletal and connective tissue disorders
Worsening knee pain and inflammation
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Skin and subcutaneous tissue disorders
Lips raw on inside
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Decreased frequency of bowel movements
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Explosive bowel movement)
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Metabolism and nutrition disorders
Fatigue
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Infections and infestations
Infection- Leg sore
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
11.8%
2/17 • Number of events 2 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Acid reflux/ increased acid reflux
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
5.9%
1/17 • Number of events 1 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
11.8%
2/17 • Number of events 2 • Reporting time frame (ex. Baseline through 4 weeks): Intervention visit through final in person visit
|
Additional Information
Lindsay Reynolds, PhD
Wake Forest University Health Sciences
Phone: 336.713.1134
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place