Abdominal FatPhase 3NCT01239147
Effects of Whole Grain on Weight Maintenance
A Phase 3 study testing Diet rich in whole grain and Refined grain in people with Abdominal Fat and Body Weight, run by Cereal Partners Worldwide at 1 site in France.
Trial summary
Epidemiological studies suggest that whole grain consumption affects measures of obesity including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate rather consistently an inverse association between BMI and whole grain consumption. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Fat, Body Weight
- What is being tested?
- Diet rich in whole grain and Refined grain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Apr 2013
- Phase
- Phase 3
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject, as determined by clinical examination, and medical history,
- Non-menopausal woman,
- BMI between 27 and 34 kg/m²
- Waist circumference > 80 cm.
- No diet within the last 3 months with weight loss or gain not more than 3kg.
- Non-smoking subject, or smoking less than 15 cigarettes/day since three months,
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- Normal blood pressure (BP) and heart rate (HR) after 10 minutes in supine position. Individuals values out of the normal range can be accepted if judged clinically non relevant by the investigator.
- Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator.
- Subject with a habitual low (< 16 g/day) intake of whole grain foods (from cereal food intake questionnaire),
- willing to eat breakfast cereals
- no intense physical activity,
- written consent to participate in the study,
- covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
- registered in the national file of volunteers participating in biomedical research,
- Subject who has lost at least 6% initial body weight after the weight loss diet will be randomized to either the whole grain or the refined grain diet
Who cannot join
- Subject having a history of metabolic disease (i.e, diabetes),
- Subject suffering from chronic renal insufficiency
- Subject receiving a local or general treatment (i.e, prescription medications, over-the-counter medications, dietary supplements or herbal supplements) susceptible to interfere with the evaluation of the studied parameters and in particular weight (eg, appetite suppressants, slimming or treatment which could interfere with the metabolism and dietary behaviour),
- Subject with ongoing medication not stabilized since more than 3 months,
- Subject having had a general anaesthesia in the month preceding inclusion, or gastro-intestinal surgery at any time in his/her life, with the possible exception of appendectomy,
- Pregnant or breast-feeding subject (positive urinary pregnancy test),
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- Subject in an exclusion period of a previous study or having participated in another clinical study in the last month,
- Use of laxatives, except in few occasions, if, in the opinion of the investigator, does not interfere with the optimal participation,
- Subject having received more than 4500 Euros in indemnity for participation in clinical studies in the last 12 months, including participation in the present study,
- Subject in a situation that, in the opinion of the investigator, could interfere with his optimal participation in the study or constitute a particular risk for the subject,
- Subject under any administrative or legal supervision.
- Subjects with known allergies to cereals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Grain Inclusion in the Diet on Abdominal Fat Regain After a Weight Loss Diet
Epidemiological studies suggest that whole grain consumption affects measures of obesity including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate rather consistently an inverse association between BMI and whole grain consumption. Furthermore, prospective cohort studies suggest that people with high whole grain consumption have less risk for body weight gain compared with low whole grain consumption.
The purpose of this study is to assess the effects of inclusion of whole grain in the diet on anthropometric measures, particularly abdominal fat regain after a weight loss diet.
It is anticipated that the short-term regain of abdominal fat after a weight loss diet is lower in volunteers consuming whole grain than in volunteers consuming refined grain.
- Conditions
- Abdominal Fat, Body Weight
- Being tested
- Diet rich in whole grain, Refined grain
- Keywords
- weight maintenance
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet rich in whole grainOther
Ready-to-eat breakfast cereals and other cereal products, rich in whole grain
Refined grainOther
Ready-to-eat breakfast cereals and other cereal products, low in whole grain
| Study group | Role | What they receive |
|---|---|---|
| Whole grain diet | Other | Not described Receives: Other: Diet rich in whole grain |
| Refined grain diet | Other | Not described Receives: Other: Refined grain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal fat
Abdominal fat mass (DEXA)
Measured: 12 weeks
Secondary outcomes (2)
Body composition
Body composition (DEXA
Measured: 12 weeks
body weight
body weight (kg)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal FatStudies of the same condition, open and under way.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cereal Partners Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves DONAZZOLO, MD, MSc, Principal investigator, Optimed Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239147
- Sponsor's protocol ID
- 2009.02.CPW / OP71709.UPC.CPW
- Status last verified
- Apr 2013
- First submitted
- 27 Oct 2010
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Grain Inclusion in the Diet on Abdominal Fat Regain After a Weight Loss Diet
- ClinicalTrials.gov ID
- NCT01239147
- Acronym / sponsor ID
- 2009.02.CPW / OP71709.UPC.CPW
- Conditions
- Abdominal Fat, Body Weight
- Keywords
- weight maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Cereal Partners WorldwideIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Nov 2010 (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.
Epidemiological studies suggest that whole grain consumption affects measures of obesity including BMI, body fat tissue, and body weight. Most cross-sectional studies demonstrate rather consistently an inverse association between BMI and whole grain consumption. Furthermore, prospective cohort studies suggest that people with high whole grain consumption have less risk for body weight gain compared with low whole grain consumption.
The purpose of this study is to assess the effects of inclusion of whole grain in the diet on anthropometric measures, particularly abdominal fat regain after a weight loss diet.
It is anticipated that the short-term regain of abdominal fat after a weight loss diet is lower in volunteers consuming whole grain than in volunteers consuming refined grain.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole grain diet | Other | Other: Diet rich in whole grain |
| Refined grain diet | Other | Other: Refined grain |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy subject, as determined by clinical examination, and medical history,
- Non-menopausal woman,
- BMI between 27 and 34 kg/m²
- Waist circumference > 80 cm.
- No diet within the last 3 months with weight loss or gain not more than 3kg.
Key exclusion criteria (12 listed)
- Subject having a history of metabolic disease (i.e, diabetes),
- Subject suffering from chronic renal insufficiency
- Subject receiving a local or general treatment (i.e, prescription medications, over-the-counter medications, dietary supplements or herbal supplements) susceptible to interfere with the evaluation of the studied parameters and in particular weight (eg, appetite suppressants, slimming or treatment which could interfere with the metabolism and dietary behaviour),
- Subject with ongoing medication not stabilized since more than 3 months,
- Subject having had a general anaesthesia in the month preceding inclusion, or gastro-intestinal surgery at any time in his/her life, with the possible exception of appendectomy,
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 |
|---|---|---|
| Diet rich in whole grainReady-to-eat breakfast cereals and other cereal products, rich in whole grain | Other | Whole grain diet |
| Refined grainReady-to-eat breakfast cereals and other cereal products, low in whole grain | Other | Refined grain diet |
Primary outcome
Abdominal fat
Time frame: 12 weeks
Abdominal fat mass (DEXA)
2 secondary outcomes
Body composition
Time frame: 12 weeks
body weight
Time frame: 12 weeks
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 29 Apr 2013.
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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.
Yves DONAZZOLO, MD, MSc principal investigator
Optimed Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diet rich in whole grain and Refined grain in people with Abdominal Fat and Body Weight, run by Cereal Partners Worldwide at 1 site in France.
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 15 inclusion and 12 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 29 Apr 2013. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Abdominal fat (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2013.