An interventional study of Propionate ester and Inulin in Obesity, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Imperial College London · Not applicable, Interventional, and Prevention
This study explores the nutritional effects of fibre. Short chain fatty acid(SCFA), such as propionate, are produced through the fermentation of fibre in the bowel. SCFA are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. This study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.
This is a dose finding study in healthy overweight to obese human volunteers (BMI 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. This study will compare propionate with fermentable and non fermentable carbohydrate. The outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using MRI scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Dietary Supplement: Propionate ester
Dietary Supplement: Inulin
Dietary Supplement: Cellulose
The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
Appetite_Food Intake
The change in food intake following 24 weeks of supplementation
Time frame: Baseline, 24 weeks
Body Weight
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Time frame: Baseline, 24 weeks
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Time frame: Baseline, 24 weeks
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.
Time frame: 24 weeks
Insulin Sensitivity - HOMA IR
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.
Time frame: 24 weeks
| Milestone | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| Started | 31 | 29 |
| Completed | 24 | 25 |
| Not completed | 7 | 4 |
| Withdrew: Protocol violation | 4 | 1 |
| Withdrew: Physician decision | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
The change in food intake following 24 weeks of supplementation
| kcal | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| Baseline | 678 (535 to 820) | 836 (724 to 948) |
| 24 weeks | 645 (514 to 776) | 763 (654 to 872) |
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
| kg | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| Baseline | 91 ± 2.8 | 88.5 ± 2.9 |
| 24 weeks | 91.4 ± 3 | 87.5 ± 3 |
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
| Participants | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight | 6 | 1 |
Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.
| percentage of total adipose tissue | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| Baseline | 10.6 ± 1.3 | 13.2 ± 1.2 |
| 24 weeks | 11.1 ± 1.4 | 13.1 ± 1.1 |
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.
| percentage of Beta Cell Function | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| Baseline | 2.7 ± 0.3 | 2 ± 0.2 |
| 24 weeks | 2.3 ± 0.2 | 2 ± 0.2 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inulin-control | 0/31 (0%) | 0/31 (0%) | 14/31 (45.2%) |
| Inulin-propionate Ester | 0/29 (0%) | 0/29 (0%) | 5/29 (17.2%) |
| Event | Inulin-control | Inulin-propionate Ester |
|---|---|---|
| FlatulenceGastrointestinal disorders | 14/31 | 5/29 |
| Stomach discomfortGastrointestinal disorders | 8/31 | 1/29 |
| BloatingGastrointestinal disorders | 8/31 | 3/29 |
| HeartburnsGastrointestinal disorders | 3/31 | 2/29 |
| BelchingGastrointestinal disorders | 2/31 | 1/29 |
| Age, Categorical(Participants) | Inulin-control | Inulin-propionate Ester | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 25 | 49 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Inulin-control | Inulin-propionate Ester | Total |
|---|---|---|---|
| Mean | 53.4 ± 1.5 | 55.3 ± 1.4 | 54 ± 1.4 |
| Sex: Female, Male(Participants) | Inulin-control | Inulin-propionate Ester | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 9 | 10 | 19 |
| Race (NIH/OMB)(Participants) | Inulin-control | Inulin-propionate Ester | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 5 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 18 | 16 | 34 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Inulin-control | Inulin-propionate Ester | Total |
|---|---|---|---|
| United Kingdom | 24 | 25 | 49 |
| HbA1c(mmol/mol) | Inulin-control | Inulin-propionate Ester | Total |
|---|---|---|---|
| Mean | 37.8 ± 0.5 | 38.2 ± 0.7 | 38 ± 0.6 |
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Imperial College London