Fibre and Appetite Regulation Trial (FART)

Study Overview
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Brief Summary
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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

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

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Drug: Low fibre breakfast cereal (puffed rice/cornflakes)
* Drug: High fibre cereal (All Bran/Bran Flakes)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Low fibre breakfast cereal (puffed rice/cornflakes)|nan|
|Drug: High fibre cereal (All Bran/Bran Flakes)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Human nutrition, Dietary fibre, Insulin resistance, Glucose, Colonic fermentation, Short chain fatty acids, GLP-1, Appetite, Abdominal fat