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Effect of Fibre Products on Appetite and Weight

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00750438
First received: September 9, 2008
Last updated: November 18, 2016
Last verified: July 2009

September 9, 2008
November 18, 2016
September 2008
July 2012   (Final data collection date for primary outcome measure)
  • Appetite, [ Time Frame: 24 weeks ]
  • Body weight [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT00750438 on ClinicalTrials.gov Archive Site
  • Adipose tissue distribution, [ Time Frame: 24 weeks ]
  • Insulin sensitivity [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
 
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.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Obesity
  • 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
  • Dietary Supplement: Inulin
    The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
  • Dietary Supplement: Cellulose
    The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.
  • Experimental: Propionate ester
    Intervention: Dietary Supplement: Propionate ester
  • Placebo Comparator: Fermentable control
    Intervention: Dietary Supplement: Inulin
  • Placebo Comparator: Non fermentable control
    Intervention: Dietary Supplement: Cellulose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
October 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00750438
08/H0707/99
Yes
Not Provided
Not Provided
Not Provided
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Gary Frost, PhD Imperial College London
Imperial College London
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP