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Effect of Fibre Products on Appetite and Weight

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ClinicalTrials.gov Identifier: NCT00750438
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : November 7, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Propionate ester Dietary Supplement: Inulin Dietary Supplement: Cellulose Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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.
Actual Study Start Date : September 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Appetite_Food Intake [ Time Frame: Baseline, 24 weeks ]
    The change in food intake following 24 weeks of supplementation

  2. Body Weight [ Time Frame: Baseline, 24 weeks ]
    Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.

  3. Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight [ Time Frame: Baseline, 24 weeks ]
    Body weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.


Secondary Outcome Measures :
  1. Adipose Tissue Distribution - Intra-abdominal Adipose Tissue [ Time Frame: 24 weeks ]
    Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.

  2. Insulin Sensitivity - HOMA IR [ Time Frame: 24 weeks ]
    The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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
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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
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United Kingdom
Hammersmith Hospital
London, UK, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Gary Frost, PhD Imperial College London
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00750438    
Other Study ID Numbers: 08/H0707/99
First Posted: September 10, 2008    Key Record Dates
Results First Posted: November 7, 2019
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Obesity
Short chain fatty acids
Appetite
Body weight
 Insulin sensitivity
Propionate
Propionate ester
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight