Trial Outcomes & Findings for Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans (NCT NCT02037295)
NCT ID: NCT02037295
Last Updated: 2020-07-31
Results Overview
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Days 5-7 and 11-13
Results posted on
2020-07-31
Participant Flow
Participant milestones
| Measure |
OF_UF Vancomycin
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin
Vancomycin: Vancomycin 125mg orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
OF_UF Placebo
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo
Placebo oral tablet: Placebo pills orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
UF_OF Vancomycin
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin
Vancomycin: Vancomycin 125mg orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
UF_OF Placebo
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo
Placebo oral tablet: Placebo pills orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|---|---|
|
Phase 1: Crossover UF and OF
STARTED
|
9
|
7
|
4
|
7
|
|
Phase 1: Crossover UF and OF
COMPLETED
|
9
|
7
|
4
|
7
|
|
Phase 1: Crossover UF and OF
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2: Vancomycin and Placebo
STARTED
|
9
|
7
|
4
|
7
|
|
Phase 2: Vancomycin and Placebo
COMPLETED
|
8
|
7
|
4
|
6
|
|
Phase 2: Vancomycin and Placebo
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
OF_UF Vancomycin
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin
Vancomycin: Vancomycin 125mg orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
OF_UF Placebo
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo
Placebo oral tablet: Placebo pills orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
UF_OF Vancomycin
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin
Vancomycin: Vancomycin 125mg orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
UF_OF Placebo
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo
Placebo oral tablet: Placebo pills orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|---|---|
|
Phase 2: Vancomycin and Placebo
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
Baseline characteristics by cohort
| Measure |
OF_UF Vancomycin
n=9 Participants
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then vancomycin
Vancomycin: Vancomycin 125mg orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
OF_UF Placebo
n=7 Participants
Healthy volunteers assigned overfeeding diet, underfeeding diet, and then placebo
Placebo oral tablet: Placebo pills orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
UF_OF Vancomycin
n=4 Participants
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then vancomycin
Vancomycin: Vancomycin 125mg orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
UF_OF Placebo
n=7 Participants
Healthy volunteers assigned underfeeding diet, overfeeding diet, and then placebo
Placebo oral tablet: Placebo pills orally four times per day for 12 days
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 13.3 • n=93 Participants
|
34.9 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
29.7 years
STANDARD_DEVIATION 4.4 • n=27 Participants
|
38.4 years
STANDARD_DEVIATION 3.6 • n=483 Participants
|
35.1 years
STANDARD_DEVIATION 7.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Days 5-7 and 11-13Population: 4 subjects were excluded from the analysis because the delineation of the diet periods using two dye markers was not clear
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day)
Outcome measures
| Measure |
Overfeeding
n=23 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=23 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Stool Calories During OF and UF
|
5.8 percentage of calorie intake
Standard Deviation 1.9
|
8.9 percentage of calorie intake
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: Days 23-25Population: Phase 2: Of the 27 participants enrolled, 2 participants dropped out and 1 had missing stool data
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
Outcome measures
| Measure |
Overfeeding
n=11 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=13 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Stool Calories During Vancomycin and Placebo
|
8.4 percentage of calorie intake
Standard Deviation 1.9
|
5.6 percentage of calorie intake
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Days 5-7 and 11-13Population: 4 subjects were excluded from the analysis because the delineation of the diet periods using two dye markers was not clear
Calculated as urine calories (kcal/day) x 100/ingested calories (kcal/day)
Outcome measures
| Measure |
Overfeeding
n=23 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=23 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Urine Calories During OF and UF
|
1.1 percentage of calorie intake
Standard Deviation 0.2
|
2.3 percentage of calorie intake
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Days 23-25Population: Phase 2: Of the 27 participants enrolled, 2 participants dropped out and 1 had missing stool data
Calculated as urine calories (kcal/day) x 100/ingested calories (kcal/day), vancomycin compared to placebo
Outcome measures
| Measure |
Overfeeding
n=11 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=13 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Urine Calories During Vancomycin and Placebo
|
1.3 percentage of calorie intake
Standard Deviation 0.3
|
1.3 percentage of calorie intake
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Day 16 and day 28Population: Phase 2: Of the 27 participants enrolled, 2 participants dropped out and 1 had a missing OGTT.
A 75-g 2 hour oral glucose tolerance test (OGTT) was performed on days 16 and 28, before and after treatment with vancomycin or placebo.
Outcome measures
| Measure |
Overfeeding
n=12 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=12 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Change in 2 Hour Glucose Tolerance From Day 16 to Day 28 During Vancomycin and Placebo
|
1.3 mg/dL
Standard Deviation 16.8
|
-1.9 mg/dL
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Days 5-7 and 11-13Population: Data were available during both diets for only 15 subjects
qPCR-based quantification of 16S rRNA gene copies per gram wet weight (log10)
Outcome measures
| Measure |
Overfeeding
n=15 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=15 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Overall Gut Microbial Colonization During OF and UF
|
9.39 log 10 copies per gram weight
Interval 9.21 to 9.98
|
9.73 log 10 copies per gram weight
Interval 9.32 to 10.52
|
SECONDARY outcome
Timeframe: Days 23-25Population: Data were available for only 23 subjects
qPCR-based quantification of 16S rRNA gene copies per gram wet weight (log10)
Outcome measures
| Measure |
Overfeeding
n=11 Participants
Healthy volunteers assigned overfeeding diet
Overfeeding diet (OF): Diet in which the calories are 150% of their weight maintaining energy requirements
|
Underfeeding
n=12 Participants
Healthy volunteers assigned underfeeding diet
Underfeeding diet (UF): Diet in which the calories are 50% of their weight maintaining energy requirements
|
|---|---|---|
|
Overall Gut Microbial Colonization During Vancomycin and Placebo
|
9.92 log 10 copies per gram weight
Interval 9.41 to 10.14
|
9.42 log 10 copies per gram weight
Interval 9.07 to 10.06
|
Adverse Events
Overfeeding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Underfeeding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan Krakoff, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (602) 200-5217
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place