Fibre and Appetite Regulation Trial (FART)

Not Applicable

Completed

• Conditions: Obesity; Diabetes

• Registration Number: NCT00247455
• Lead Sponsor: University of Toronto

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study Completion: 2005-08
• Study First Submitted: 2005-10-28
• Study First Submitted QC: 2005-10-31
• Study First Posted: 2005-11-01
• Status Verified: 2007-08
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum acetate concentration	0, 3, 6, 9 and 12 months
Serum butyrate concentration	0, 3, 6, 9 and 12 months
Plasma GLP-1 concentration	0, 3, 6, 9 and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada