Fibre and Appetite Regulation Trial (FART)

NCT00247455 | Completed

• 3 other identifiers: CDA1323Can Diabetes Assoc Grant 1323CIHR Grant OOP-64648
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Diabetes

Keywords

Human nutrition; Dietary fibre; Insulin resistance; Obesity; Glucose; Colonic fermentation; Short chain fatty acids; GLP-1; Appetite; Abdominal fat

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Fasting glucose and insulin

  0, 3, 6, 9 and 12 months

• 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

• Body weight

  0, 3, 6, 9 and 12 months

• waist circumference

  0, 3, 6, 9 and 12 months

Interventions

Low fibre breakfast cereal (puffed rice/cornflakes) DRUG

High fibre cereal (All Bran/Bran Flakes) DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Diabetes Association: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related 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. Epub 2009 Aug 7.

  PMID: 19664300 RESULT

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Thomas MS Wolever, BM, BCh, PhD, DM

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: November 1, 2005
• Study Start: March 1, 2002
• Study Completion: August 1, 2005
• Last Updated: June 21, 2011

Record last verified: 2007-08

Locations

CA (1)