This trial is active, not recruiting.

Condition obesity
Treatments propionate ester, inulin, cellulose
Sponsor Imperial College London
Start date September 2008
End date July 2011
Trial size 97 participants
Trial identifier NCT00750438, 08/H0707/99, R&D FROG1068, REC approval 08/H0707/99


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
propionate ester
The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
(Placebo Comparator)
The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
(Placebo Comparator)
The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.

Primary Outcomes

time frame: 24 weeks
Body weight
time frame: 24 weeks

Secondary Outcomes

Adipose tissue distribution,
time frame: 24 weeks
Insulin sensitivity
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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 - Diabetes - Cardiovascular disease - Cancer - 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.

Additional Information

Official title Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
Principal investigator Gary Frost, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Imperial College London.