Obesity
Conditions
Brief summary
The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota transplantation (FMT) transfers intestinal bacteria by a stool transplant from a healthy, lean person to a person with obesity.
Detailed description
Multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism. In this study, subjects will receive FMT capsules from lean metabolically healthy donors to study effects on body weight and insulin sensitivity. Subjects who participate will be randomized 1:1 to receive either active FMT capsules or placebo capsules. Subjects and providers will be blinded to treatment assignment. The study will last for 24 weeks. Subjects will be asked to come to MGH for a baseline visit at week 0, return for 6 weekly visits and come back at week 12. Major study outcomes include change in weight, insulin sensitivity, and body composition. Fecal samples will also be collected for intestinal microbiome analysis.
Interventions
OTHERPlacebo Capsules
Placebo capsules contain powdered cocoa and gelatin
BIOLOGICALFMT Capsules
Capsules will be generated as per FDA-approved procedures
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥30 kg/m2 * Because of frequent study mandated visits, only subjects living within reasonable driving distance of Massachusetts General Hospital may be enrolled
Exclusion criteria
* Pregnant women * Use of diabetic medications or weight loss medications in the preceding 1 year * Significant gastrointestinal disorders * Significant food allergies * Immunosuppressed patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp | Baseline and 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline and 12 weeks | — |
| Body Weight (Metabolic Scale) | Baseline and 12 weeks | Change in body weight from baseline to 12 weeks will be measured on a metabolic scale. |
| Lean Mass | Baseline and 12 weeks | Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry |
| Fat Mass | Baseline and 12 weeks | Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FMT Capsules Active FMT capsules
FMT Capsules: Capsules will be generated as per FDA-approved procedures | 12 |
| Placebo Placebo capsules
Placebo Capsules: Placebo capsules contain powdered cocoa and gelatin | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | FMT Capsules | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Continuous | 42.5 years STANDARD_DEVIATION 8.4 | 38.5 years STANDARD_DEVIATION 8.8 | 40.5 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 11 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 7 / 12 | 10 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
Primary
Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
Time frame: Baseline and 6 weeks
Population: 2 participants in the FMT Capsules group did not complete the 6 week study visit: 1 withdrew prior to the visit; 1 missed due to a scheduling issue.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp | -3 percent change | Standard Deviation 32 |
| FMT Capsules | Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp | 5 percent change | Standard Deviation 12 |
p-value: 0.16Wilcoxon (Mann-Whitney)
Secondary
Body Weight (Metabolic Scale)
Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Body Weight (Metabolic Scale) | Baseline | 111 kg | Standard Deviation 20 |
| Placebo | Body Weight (Metabolic Scale) | 12 weeks | 111 kg | Standard Deviation 19 |
| FMT Capsules | Body Weight (Metabolic Scale) | Baseline | 110 kg | Standard Deviation 26 |
| FMT Capsules | Body Weight (Metabolic Scale) | 12 weeks | 111 kg | Standard Deviation 27 |
p-value: 0.93Mixed Models Analysis
Secondary
Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline | 3.5 unitless | Standard Deviation 1.9 |
| Placebo | Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | 12 weeks | 4.8 unitless | Standard Deviation 1.7 |
| FMT Capsules | Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline | 3.5 unitless | Standard Deviation 1.4 |
| FMT Capsules | Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR) | 12 weeks | 4.7 unitless | Standard Deviation 2 |
p-value: 0.7Mixed Models Analysis
Secondary
Fat Mass
Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Fat Mass | Baseline | 53 kg | Standard Deviation 10 |
| Placebo | Fat Mass | 12 weeks | 52 kg | Standard Deviation 10 |
| FMT Capsules | Fat Mass | Baseline | 49 kg | Standard Deviation 13 |
| FMT Capsules | Fat Mass | 12 weeks | 50 kg | Standard Deviation 14 |
p-value: 0.32Mixed Models Analysis
Secondary
Lean Mass
Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Lean Mass | Baseline | 58 kg | Standard Deviation 12 |
| Placebo | Lean Mass | 12 week | 58 kg | Standard Deviation 11 |
| FMT Capsules | Lean Mass | Baseline | 60 kg | Standard Deviation 15 |
| FMT Capsules | Lean Mass | 12 week | 61 kg | Standard Deviation 16 |
p-value: 0.9Mixed Models Analysis