Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Appetite_Food Intake
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female volunteers aged between 21 and 65 years
Exclusion Criteria
- •Weight change of more than 3kg in the preceding 2 months
- •Current smokers
- •Substance abuse
- •Excess alcohol intake
- •Pregnancy
- •Cardiovascular disease
- •Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- •Kidney disease
- •Liver disease
- •Pancreatitis
- •Use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.
Outcomes
Primary Outcomes
Appetite_Food Intake
Time Frame: Baseline, 24 weeks
The change in food intake following 24 weeks of supplementation
Body Weight
Time Frame: Baseline, 24 weeks
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
Time Frame: Baseline, 24 weeks
Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Secondary Outcomes
- Adipose Tissue Distribution - Intra-abdominal Adipose Tissue(24 weeks)
- Insulin Sensitivity - HOMA IR(24 weeks)