Trial Outcomes & Findings for Effects of Dietary Fructose on Gut Microbiota and Fecal Metabolites in Obese Men and Postmenopausal Women: A Pilot Study (NCT NCT03339245)
NCT ID: NCT03339245
Last Updated: 2021-03-26
Results Overview
Difference in the distribution of fecal microbiota in each participant, between the fructose versus glucose supplemented diet arms of the study, as measured at the end of each intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
assessed at Day 16 of each intervention, up to 64 days
Results posted on
2021-03-26
Participant Flow
Participant milestones
| Measure |
Fructose, Then Glucose
Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
Glucose, Then Fructose
Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Fructose, Then Glucose
Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
Glucose, Then Fructose
Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The row population indicates the N in each arm. This is a cross-over study, so each participant received the same intervention but in different order
Baseline characteristics by cohort
| Measure |
Glucose, Then Fructose
n=7 Participants
Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
Fructose, Then Glucose
n=6 Participants
Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58 years
n=5 Participants • The row population indicates the N in each arm. This is a cross-over study, so each participant received the same intervention but in different order
|
57 years
n=7 Participants • The row population indicates the N in each arm. This is a cross-over study, so each participant received the same intervention but in different order
|
57.6 years
n=5 Participants • The row population indicates the N in each arm. This is a cross-over study, so each participant received the same intervention but in different order
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at Day 16 of each intervention, up to 64 daysPopulation: Investigator has retired and access to results for each arm was not available for this outcome. Best efforts were made to obtain the data from the investigator; however, they were unsuccessful.
Difference in the distribution of fecal microbiota in each participant, between the fructose versus glucose supplemented diet arms of the study, as measured at the end of each intervention.
Outcome measures
Outcome data not reported
Adverse Events
Fructose, Then Glucose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Glucose, Then Fructose
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 |
Fructose, Then Glucose
n=4 participants at risk
Participants first receive Fructose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Glucose Solution (75 grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
Glucose, Then Fructose
n=6 participants at risk
Participants first receive Glucose Solution (75 grams) from Day 3 through Day 16 of an inpatient stay with usual diet. After a 2-3 week washout period, they will then receive Fructose Solution (75 Grams) from Day 3 through Day 16 on a second inpatient stay with usual diet.
Fructose Solution (75 Grams): Fructose given in divided doses at breakfast and dinner.
Glucose Solution (75 grams): Glucose given in divided doses at breakfast and dinner.
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
50.0%
2/4 • Number of events 4 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
50.0%
3/6 • Number of events 3 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
|
Gastrointestinal disorders
nausea
|
25.0%
1/4 • Number of events 1 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
0.00%
0/6 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
|
Metabolism and nutrition disorders
elevated blood glucose
|
25.0%
1/4 • Number of events 1 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
16.7%
1/6 • Number of events 1 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
|
Nervous system disorders
lightheadedness
|
25.0%
1/4 • Number of events 1 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
0.00%
0/6 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
|
Musculoskeletal and connective tissue disorders
low back pain
|
0.00%
0/4 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
16.7%
1/6 • Number of events 1 • 10 months
Adverse event data are reported per arm/group. Adverse event per intervention are not available because the Investigator has retired. Best efforts were made to obtain and reexamine the adverse event data; however, they were unsuccessful.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place