Clinical trial NCT00247455: Fibre and Appetite Regulation Trial (FART)
Official title: Long-term Effect of Cereal Fibre on Abdominal Fat in Insulin Resistant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: Human nutrition
Dietary fibre
Insulin resistance
Obesity
Glucose
Colonic fermentation
Short chain fatty acids
GLP-1
Appetite
Abdominal fat
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-11-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Serum acetate concentration
timeFrame: 0, 3, 6, 9 and 12 months
measure: Serum butyrate concentration
timeFrame: 0, 3, 6, 9 and 12 months
measure: Plasma GLP-1 concentration
timeFrame: 0, 3, 6, 9 and 12 months
Secondary outcomes:
measure: Fasting glucose and insulin
timeFrame: 0, 3, 6, 9 and 12 months
measure: HOMA insulin resistance and beta cell function
timeFrame: 0, 3, 6, 9 and 12 months
measure: postprandial glucose and insulin
timeFrame: 0, 3, 6, 9 and 12 months
measure: Body weight
timeFrame: 0, 3, 6, 9 and 12 months
measure: waist circumference
timeFrame: 0, 3, 6, 9 and 12 months
measure: Abdominal fat
timeFrame: 0 and 12 months
measure: food intake
timeFrame: 0, 3, 6, 9 and 12 months
measure: Fasting lipids (cholesterol, triglyceride, HDL, LDL)
timeFrame: 0, 3, 6, 9 and 12 months
measure: Fasting and postprandial free fatty acids and triglycerides
timeFrame: 0, 3, 6, 9 and 12 months
measure: Fasting and postprandial c-peptide
timeFrame: 0, 3, 6, 9 and 12 months
measure: C-peptide/insulin ratio as marker of hepatic insulin extraction
timeFrame: 0, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Thomas MS Wolever, BM, BCh, PhD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.