Fibre and Appetite Regulation Trial (FART)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2005-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Low fibre breakfast cereal (puffed rice/cornflakes)

Intervention Type DRUG

High fibre cereal (All Bran/Bran Flakes)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes