ObesityNCT00247455
Fibre and Appetite Regulation Trial (FART)
A study testing Low fibre breakfast cereal (puffed rice/cornflakes) and High fibre cereal (All Bran/Bran Flakes) in people with Obesity and Diabetes, run by University of Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Low fibre breakfast cereal (puffed rice/cornflakes) and High fibre cereal (All Bran/Bran Flakes)
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2002to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-diabetic male or non-pregnant females
- aged 18-60
- BMI<36
- fasting insulin >40pmol/L (70%ile)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effect of Cereal Fibre on Abdominal Fat in Insulin Resistant Subjects
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
- Being tested
- Low fibre breakfast cereal (puffed rice/cornflakes), High fibre cereal (All Bran/Bran Flakes)
- Keywords
- Human nutrition, Dietary fibre, Insulin resistance, Obesity, Glucose, Colonic fermentation, Short chain fatty acids, GLP-1, Appetite, Abdominal fat
- Medical subject headings
- Obesity, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fibre breakfast cereal (puffed rice/cornflakes)Drug
High fibre cereal (All Bran/Bran Flakes)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum acetate concentration
Measured: 0, 3, 6, 9 and 12 months
Serum butyrate concentration
Measured: 0, 3, 6, 9 and 12 months
Plasma GLP-1 concentration
Measured: 0, 3, 6, 9 and 12 months
Secondary outcomes (11)
Fasting glucose and insulin
Measured: 0, 3, 6, 9 and 12 months
HOMA insulin resistance and beta cell function
Measured: 0, 3, 6, 9 and 12 months
postprandial glucose and insulin
Measured: 0, 3, 6, 9 and 12 months
Body weight
Measured: 0, 3, 6, 9 and 12 months
waist circumference
Measured: 0, 3, 6, 9 and 12 months
Abdominal fat
Measured: 0 and 12 months
food intake
Measured: 0, 3, 6, 9 and 12 months
Fasting lipids (cholesterol, triglyceride, HDL, LDL)
Measured: 0, 3, 6, 9 and 12 months
Fasting and postprandial free fatty acids and triglycerides
Measured: 0, 3, 6, 9 and 12 months
Fasting and postprandial c-peptide
Measured: 0, 3, 6, 9 and 12 months
C-peptide/insulin ratio as marker of hepatic insulin extraction
Measured: 0, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startMar 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association, Canadian Institutes of Health Research (CIHR)
- Investigators
- Thomas MS Wolever, BM, BCh, PhD, DM, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247455
- Sponsor's protocol ID
- CDA1323
- Other IDs
- Can Diabetes Assoc Grant 1323, CIHR Grant OOP-64648
- Status last verified
- Aug 2007
- First submitted
- 28 Oct 2005
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19664300
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of Cereal Fibre on Abdominal Fat in Insulin Resistant Subjects
- ClinicalTrials.gov ID
- NCT00247455
- Acronym / sponsor ID
- CDA1323
- Keywords
- Human nutrition, Dietary fibre, Insulin resistance, Obesity, Glucose, Colonic fermentation, Short chain fatty acids, GLP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association, Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-diabetic male or non-pregnant females
- aged 18-60
- BMI<36
- fasting insulin >40pmol/L (70%ile)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low fibre breakfast cereal (puffed rice/cornflakes) | Drug | – |
| High fibre cereal (All Bran/Bran Flakes) | Drug | – |
Primary outcome
Serum acetate concentration
Time frame: 0, 3, 6, 9 and 12 months
Serum butyrate concentration
Time frame: 0, 3, 6, 9 and 12 months
Plasma GLP-1 concentration
Time frame: 0, 3, 6, 9 and 12 months
11 secondary outcomes
Fasting glucose and insulin
Time frame: 0, 3, 6, 9 and 12 months
HOMA insulin resistance and beta cell function
Time frame: 0, 3, 6, 9 and 12 months
postprandial glucose and insulin
Time frame: 0, 3, 6, 9 and 12 months
Body weight
Time frame: 0, 3, 6, 9 and 12 months
waist circumference
Time frame: 0, 3, 6, 9 and 12 months
Abdominal fat
Time frame: 0 and 12 months
food intake
Time frame: 0, 3, 6, 9 and 12 months
Fasting lipids (cholesterol, triglyceride, HDL, LDL)
Time frame: 0, 3, 6, 9 and 12 months
Fasting and postprandial free fatty acids and triglycerides
Time frame: 0, 3, 6, 9 and 12 months
Fasting and postprandial c-peptide
Time frame: 0, 3, 6, 9 and 12 months
C-peptide/insulin ratio as marker of hepatic insulin extraction
Time frame: 0, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
- Results publication: PubMed 19664300Freeland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas MS Wolever, BM, BCh, PhD, DM principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fibre breakfast cereal (puffed rice/cornflakes) and High fibre cereal (All Bran/Bran Flakes) in people with Obesity and Diabetes, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum acetate concentration (time frame: 0, 3, 6, 9 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2011.