Effect of Fibre Products on Appetite and Weight
Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Sep 2008
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
November 7, 2019
CompletedNovember 19, 2019
November 1, 2019
3.8 years
September 9, 2008
October 16, 2019
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Appetite_Food Intake
The change in food intake following 24 weeks of supplementation
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.
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.
Baseline, 24 weeks
Secondary Outcomes (2)
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
24 weeks
Insulin Sensitivity - HOMA IR
24 weeks
Study Arms (3)
Propionate ester
EXPERIMENTALFermentable control
PLACEBO COMPARATORNon fermentable control
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteers aged between 21 and 65 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Hospital
London, UK, W12 0NN, United Kingdom
Related Publications (2)
Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SE, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost G. Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults. Gut. 2015 Nov;64(11):1744-54. doi: 10.1136/gutjnl-2014-307913. Epub 2014 Dec 10.
PMID: 25500202RESULTByrne CS, Chambers ES, Alhabeeb H, Chhina N, Morrison DJ, Preston T, Tedford C, Fitzpatrick J, Irani C, Busza A, Garcia-Perez I, Fountana S, Holmes E, Goldstone AP, Frost GS. Increased colonic propionate reduces anticipatory reward responses in the human striatum to high-energy foods. Am J Clin Nutr. 2016 Jul;104(1):5-14. doi: 10.3945/ajcn.115.126706. Epub 2016 May 11.
PMID: 27169834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Gary Frost
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Frost, PhD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2008
First Posted
September 10, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2012
Study Completion
October 1, 2012
Last Updated
November 19, 2019
Results First Posted
November 7, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share