Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Imperial College London |
---|---|
Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00750438 |
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.
Condition | Intervention |
---|---|
Obesity |
Dietary Supplement: Propionate ester Dietary Supplement: Inulin Dietary Supplement: Cellulose |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity. |
Estimated Enrollment: | 97 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Propionate ester: Experimental |
Dietary Supplement: Propionate ester
The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks
|
Fermentable control: Placebo Comparator |
Dietary Supplement: Inulin
The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
|
Non fermentable control: Placebo Comparator |
Dietary Supplement: Cellulose
The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
|
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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gary Frost, PhD, BSc, RD | 0208 383 3242 | g.frost@imperial.ac.uk |
Contact: Sagen Zac-Varghese, MBChB, MRCP, BSc | 020 8383 3242 | s.zac-varghese@imperial.ac.uk |
United Kingdom, UK | |
Hammersmith Hospital | Recruiting |
London, UK, United Kingdom, W12 0NN | |
Contact: Gary Frost, PhD, BSc, 020 8383 3242 g.frost@imperial.ac.uk | |
Contact: Sagen Zac-Varghese, MBChB, BSc 020 8383 3242 s.zac-varghese@imperial.ac.uk | |
Principal Investigator: Gary Frost, PhD, BSc | |
Sub-Investigator: Niamh Martin, MBChB, PhD | |
Sub-Investigator: Sagen Zac-Varghes2, MBChB, |
Principal Investigator: | Gary Frost, PhD | Imperial College London |
Responsible Party: | Imperial College London ( Professor Gary Frost ) |
Study ID Numbers: | 08/H0707/99, REC approval 08/H0707/99, R&D FROG1068 |
Study First Received: | September 9, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00750438 |
Health Authority: | United Kingdom: Research Ethics Committee |
Obesity Short chain fatty acids Appetite Body weight |
Insulin sensitivity Propionate Propionate ester |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Insulin |