Fibre and Appetite Regulation Trial (FART)

June 20, 2011 updated by: University of Toronto

Long-term Effect of Cereal Fibre on Abdominal Fat in Insulin Resistant Subjects

High intake of cereal fibre has been shown to be associated with reduced weight gain and improved insulin sensitivity. We hypothesize these effects are due to the short chain fatty acids derived from the bacterial fermentation (breakdown) of fibre in the colon (large intestine). Insulin resistant subjects will be randomized to receive 2 servings of a low-fibre cereal (eg. puffed rice) or 2 servings of a high-fibre cereal (wheat bran cereal) per day for one year. The effects of the diets on body weight, appetite, abdominal fat, blood short chain fatty acids, glucose, insulin, lipids and hormones will be measured

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-diabetic male or non-pregnant females
  • aged 18-60
  • BMI<36
  • fasting insulin >40pmol/L (70%ile)

Exclusion Criteria:

  • intention to lose >5kg in weight
  • presence of diabetes (fasting glucose >6.9mmol/L)
  • use of diuretics, beta-blockers or weight reducing drugs
  • use of antibiotics in last 3 months and use of antibiotics more than once annually for the last 2 years
  • significant gastrointestinal, liver or kidney disease
  • use of lipid-lowering drug
  • major medical or surgical event in last 6 mo.
  • fibre intake >30g/d
  • inability to eat low or high fibre breakfast cereals
  • unwilling or unable to give consent or comply with protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum acetate concentration
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Serum butyrate concentration
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Plasma GLP-1 concentration
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting glucose and insulin
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
HOMA insulin resistance and beta cell function
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
postprandial glucose and insulin
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Body weight
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
waist circumference
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Abdominal fat
Time Frame: 0 and 12 months
0 and 12 months
food intake
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Fasting lipids (cholesterol, triglyceride, HDL, LDL)
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Fasting and postprandial free fatty acids and triglycerides
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
Fasting and postprandial c-peptide
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months
C-peptide/insulin ratio as marker of hepatic insulin extraction
Time Frame: 0, 3, 6, 9 and 12 months
0, 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)
Canadian Diabetes Association

Investigators

  • Principal Investigator: Thomas MS Wolever, BM, BCh, PhD, DM, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 31, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDA1323
  • Can Diabetes Assoc Grant 1323
  • CIHR Grant OOP-64648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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