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Effect of Fibre Products on Appetite and Weight

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750438
First Posted: September 10, 2008
Last Update Posted: November 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
  Purpose
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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Appetite, [ Time Frame: 24 weeks ]
  • Body weight [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Adipose tissue distribution, [ Time Frame: 24 weeks ]
  • Insulin sensitivity [ Time Frame: 24 weeks ]

Enrollment: 58
Study Start Date: September 2008
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propionate ester 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
Placebo Comparator: Fermentable control Dietary Supplement: Inulin
The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks
Placebo Comparator: Non fermentable control Dietary Supplement: Cellulose
The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750438


Locations
United Kingdom
Hammersmith Hospital
London, UK, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Gary Frost, PhD Imperial College London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00750438     History of Changes
Other Study ID Numbers: 08/H0707/99
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: November 21, 2016
Last Verified: July 2009

Keywords provided by Imperial College London:
Obesity
Short chain fatty acids
Appetite
Body weight
Insulin sensitivity
Propionate
Propionate ester

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs