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Completed

NCT Number: NCT00247455

Fibre and Appetite Regulation Trial (FART)

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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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low fibre breakfast cereal (puffed rice/cornflakes)

Drug

High fibre cereal (All Bran/Bran Flakes)

Drug

Primary outcomes

  1. Serum acetate concentration

    Time frame: 0, 3, 6, 9 and 12 months

  2. Serum butyrate concentration

    Time frame: 0, 3, 6, 9 and 12 months

  3. Plasma GLP-1 concentration

    Time frame: 0, 3, 6, 9 and 12 months

Secondary outcomes

  1. Fasting glucose and insulin

    Time frame: 0, 3, 6, 9 and 12 months

  2. HOMA insulin resistance and beta cell function

    Time frame: 0, 3, 6, 9 and 12 months

  3. postprandial glucose and insulin

    Time frame: 0, 3, 6, 9 and 12 months

  4. Body weight

    Time frame: 0, 3, 6, 9 and 12 months

  5. waist circumference

    Time frame: 0, 3, 6, 9 and 12 months

  6. Abdominal fat

    Time frame: 0 and 12 months

  7. food intake

    Time frame: 0, 3, 6, 9 and 12 months

  8. Fasting lipids (cholesterol, triglyceride, HDL, LDL)

    Time frame: 0, 3, 6, 9 and 12 months

  9. Fasting and postprandial free fatty acids and triglycerides

    Time frame: 0, 3, 6, 9 and 12 months

  10. Fasting and postprandial c-peptide

    Time frame: 0, 3, 6, 9 and 12 months

  11. C-peptide/insulin ratio as marker of hepatic insulin extraction

    Time frame: 0, 3, 6, 9 and 12 months

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Canadian Diabetes Association
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Nov 1, 2005
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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