Effect of Oligofructose on Appetite in Overweight Subjects
|ClinicalTrials.gov Identifier: NCT00912197|
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : December 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Appetite Regulation Obesity||Dietary Supplement: Oligofructose Dietary Supplement: Placebo||Not Applicable|
Appetite regulation plays an important part in energy balance. Suppressing appetite by manipulating the diet is a safe way of reducing energy intake and body weight compared to drug therapy and obesity surgery. How various nutrients affect appetite is not fully understood. Non-digestible carbohydrates (NDC) may affect appetite differently due to differences in physio-chemical properties.
This project will look into how two different NDC affect appetite and energy intake in overweight individuals in a randomised, double-blinded, placebo controlled parallel study. The NDC under investigation are oligofructose and cellulose, both natural compounds of plant origin. The former is broken down (fermented) in the large bowel by friendly bacteria producing various compounds that may affect appetite and the metabolism of the host.
Volunteers will consume one of the two NDC for eight weeks (including a two week run-in period). Appetite study session, functional MRI (fMRI) and MRI body fat scans will be conducted before and after the supplementation with NDC (or during the supplementation in the case of fMRI). Using fMRI the effect of the NDC supplementation on central appetite regulating centres will be investigated. Appetite questionnaires and dietary records will completed under free-living conditions at baseline and during the supplementation to explore the effect on subjective appetite feelings and energy intake, respectively.
It is hoped that this project will enhance the understanding of how NDC affect appetite and provide further information on how fermentation of NDC, gut hormone release, body composition, and appetite regulation are linked.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Oligofructose on Appetite, Gut Hormones and Body Composition in Healthy Overweight Subjects|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Dietary Supplement: Oligofructose
Participants will be asked to consume 30g of oligofructose daily for six weeks after a 2-week run-in.
|Placebo Comparator: Cellulose and maltodextrin||
Dietary Supplement: Placebo
Participants will be asked to consume 3 doses (a total of 30g dietary fibres) of the placebo product daily for six weeks after a 2-week run-in
- Subjective appetite ratings [ Time Frame: Baseline and during and post-supplementation ]
- Body weight [ Time Frame: Baseline and post-supplemention ]
- Energy intake [ Time Frame: Before and during the supplementation ]
- Appetite regulating hormones [ Time Frame: At baseline and at the end of the supplemention ]
- Body composition [ Time Frame: Assessments occur at baseline and post-supplementation ]
- Imaging of appetite regulating centres (fMRI scans) [ Time Frame: At baseline and during supplementation ]
- Plasma short-chain fatty acids concentrations [ Time Frame: At baseline and post-supplementation ]
- Inflammatory markers [ Time Frame: Baseline and post-supplementation ]
- Breath hydrogen levels [ Time Frame: Baseline and post-supplementation ]
- Glycemic response [ Time Frame: baseline and post-supplementation ]
- Serum insulin [ Time Frame: Baseline and post-supplementation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912197
|Imperial College London, Hammersmith Hospital|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Gary S Frost||Imperial College London|