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Fibre and Appetite Regulation Trial (FART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247455
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : June 21, 2011
Sponsor:
Collaborators:
Canadian Diabetes Association
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Toronto

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

Condition or disease Intervention/treatment Phase
Obesity Diabetes Drug: Low fibre breakfast cereal (puffed rice/cornflakes) Drug: High fibre cereal (All Bran/Bran Flakes) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Long-term Effect of Cereal Fibre on Abdominal Fat in Insulin Resistant Subjects
Study Start Date : March 2002
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247455


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University of Toronto
Canadian Diabetes Association
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Thomas MS Wolever, BM, BCh, PhD, DM University of Toronto

Publications of Results:
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ClinicalTrials.gov Identifier: NCT00247455    
Other Study ID Numbers: CDA1323
Can Diabetes Assoc Grant 1323
CIHR Grant OOP-64648
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: August 2007
Keywords provided by University of Toronto:
Human nutrition
Dietary fibre
Insulin resistance
Obesity
Glucose
Colonic fermentation
Short chain fatty acids
GLP-1
Appetite
Abdominal fat
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs