Fibre and Appetite Regulation Trial (FART)

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247455
• Other study ID #: CDA1323
• Secondary ID: Can Diabetes Ass
• Status: Completed
• Phase: N/A
• First received: October 28, 2005
• Last updated: June 20, 2011
• Start date: March 2002
• Est. completion date: August 2005

Study information

• Verified date: August 2007
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Drug:
• Low fibre breakfast cereal (puffed rice/cornflakes)

• High fibre cereal (All Bran/Bran Flakes)

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Canadian Diabetes Association, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Freeland KR, Wilson C, Wolever TM. Adaptation of colonic fermentation and glucagon-like peptide-1 secretion with increased wheat fibre intake for 1 year in hyperinsulinaemic human subjects. Br J Nutr. 2010 Jan;103(1):82-90. doi: 10.1017/S0007114509991462. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum acetate concentration		0, 3, 6, 9 and 12 months
Primary	Serum butyrate concentration		0, 3, 6, 9 and 12 months
Primary	Plasma GLP-1 concentration		0, 3, 6, 9 and 12 months
Secondary	Fasting glucose and insulin		0, 3, 6, 9 and 12 months
Secondary	HOMA insulin resistance and beta cell function		0, 3, 6, 9 and 12 months
Secondary	postprandial glucose and insulin		0, 3, 6, 9 and 12 months
Secondary	Body weight		0, 3, 6, 9 and 12 months
Secondary	waist circumference		0, 3, 6, 9 and 12 months
Secondary	Abdominal fat		0 and 12 months
Secondary	food intake		0, 3, 6, 9 and 12 months
Secondary	Fasting lipids (cholesterol, triglyceride, HDL, LDL)		0, 3, 6, 9 and 12 months
Secondary	Fasting and postprandial free fatty acids and triglycerides		0, 3, 6, 9 and 12 months
Secondary	Fasting and postprandial c-peptide		0, 3, 6, 9 and 12 months
Secondary	C-peptide/insulin ratio as marker of hepatic insulin extraction		0, 3, 6, 9 and 12 months