ObesityHEALTHGRAINNCT00869531
Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk
A study testing wholegrain and refined wheat in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- wholegrain and refined wheat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Dec 2008
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 27-37
- Postmenopausal (>1y) women
- 40-70 years old
Who cannot join
- Medication (hypertensive treatment not included)
- BP > 160/100
- Fasting glucose > 7mM
- Fasting cholesterol > 6.5mM
- Smoking
- Known chronic illnesses
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department og Human Nutrition
Frederiksberg C, 1958
About this study
Official title: Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects
The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women.
Read the detailed description
Objective: To study the effect of the 'wholegrain concept', i.e. high intake of wheat wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.
Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic syndrome features were prescribed a mild calorie-restricted diet with a deficit of ~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks intervention with RW or WW products providing 2,000kJ/d.
- Conditions
- Obesity
- Being tested
- wholegrain, refined wheat
- Keywords
- Obesity, wholegrain, wheat, cardiovascular disease
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wholegrainOther
wholegrain wheat vs. refined wheat products
refined wheatOther
refined wheat products
| Study group | Role | What they receive |
|---|---|---|
| WW | Experimental | wholegrain wheat Receives: Other: wholegrain |
| RW | Active comparator | refined wheat Receives: Other: refined wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight and composition
Measured: 0, 6 and 12 wks
Secondary outcomes (2)
Cardiovascular risk markers
Measured: 0, 6 and 12 wks
Fecal parameters
Measured: 0 and 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startAug 2007
- Primary completionFeb 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- BARILLA G. e R. Fratelli S.p.A., Parma, Italy, European Commission
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869531
- Sponsor's protocol ID
- B223
- Acronym
- HEALTHGRAIN
- Status last verified
- Mar 2009
- First submitted
- 25 Mar 2009
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects
- ClinicalTrials.gov ID
- NCT00869531
- Acronym / sponsor ID
- HEALTHGRAIN / B223
- Conditions
- Obesity
- Keywords
- Obesity, wholegrain, wheat, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- BARILLA G. e R. Fratelli S.p.A., Parma, Italy, European Commission
- Study start
- Aug 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 Mar 2009 (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.
The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women.
Detailed description
Objective: To study the effect of the 'wholegrain concept', i.e. high intake of wheat wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.
Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic syndrome features were prescribed a mild calorie-restricted diet with a deficit of ~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks intervention with RW or WW products providing 2,000kJ/d.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WW | Experimental | Other: wholegrainwholegrain wheat |
| RW | Active comparator | Other: refined wheatrefined wheat |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 27-37
- Postmenopausal (>1y) women
- 40-70 years old
Key exclusion criteria (6 listed)
- Medication (hypertensive treatment not included)
- BP > 160/100
- Fasting glucose > 7mM
- Fasting cholesterol > 6.5mM
- Smoking
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 |
|---|---|---|
| wholegrainwholegrain wheat vs. refined wheat products | Other | WW |
| refined wheatrefined wheat products | Other | RW |
Primary outcome
Body weight and composition
Time frame: 0, 6 and 12 wks
2 secondary outcomes
Cardiovascular risk markers
Time frame: 0, 6 and 12 wks
Fecal parameters
Time frame: 0 and 12 wks
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 26 Mar 2009.
- EU project homepageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wholegrain and refined wheat in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 6 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 26 Mar 2009. 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 Denmark. 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?
Body weight and composition (time frame: 0, 6 and 12 wks). 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 26 Mar 2009.