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Effect of Fibre Products on Appetite and Weight

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Imperial College London.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00750438
First received: September 9, 2008
Last updated: July 24, 2009
Last verified: July 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.

Resource links provided by NLM:

Drug Information available for: Inulin
U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Appetite, [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adipose tissue distribution, [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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
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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Gary Frost, Imperial College London
ClinicalTrials.gov Identifier: NCT00750438     History of Changes
Other Study ID Numbers: 08/H0707/99, REC approval 08/H0707/99, R&D FROG1068
Study First Received: September 9, 2008
Last Updated: July 24, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013