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Completed

NCT Number: NCT00750438

Effect of Fibre Products on Appetite and Weight

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hammersmith Hospital

London, UK, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propionate ester

Dietary Supplement

The subject will take propionate ester at the dose specified by the dose finding study, three times a day for 24 weeks

Inulin

Dietary Supplement

The subjects in this group will take inulin at a comparable dose, three times a day for 24 weeks

Cellulose

Dietary Supplement

The subjects in this group will take the non fermentable carbohydrate, cellulose, at a comparable dose for 24 weeks.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Increased Short Chain Fatty Acids in the Colon Are Associated With Improved Energy Homeostasis and Insulin Sensitivity.

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2008
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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