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Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk (HEALTHGRAIN)

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: NCT00869531
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : March 26, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Obesity Other: wholegrain Other: refined wheat

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects
Study Start Date : August 2007
Primary Completion Date : February 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: WW
wholegrain wheat
Other: wholegrain
wholegrain wheat vs. refined wheat products
Active Comparator: RW
refined wheat
Other: refined wheat
refined wheat products


Outcome Measures

Primary Outcome Measures :
  1. Body weight and composition [ Time Frame: 0, 6 and 12 wks ]

Secondary Outcome Measures :
  1. Cardiovascular risk markers [ Time Frame: 0, 6 and 12 wks ]
  2. Fecal parameters [ Time Frame: 0 and 12 wks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 27-37
  • Postmenopausal (>1y) women
  • 40-70 years old

Exclusion Criteria:

  • Medication (hypertensive treatment not included)
  • BP > 160/100
  • Fasting glucose > 7mM
  • Fasting cholesterol > 6.5mM
  • Smoking
  • Known chronic illnesses
Contacts and Locations

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): NCT00869531


Locations
Denmark
University of Copenhagen, Department og Human Nutrition
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
BARILLA G. e R. Fratelli S.p.A., Parma, Italy
the European Commission in the Communities 6th Framework Programme, Project HEALTHGRAIN (FOOD-CT-2005-514008)
More Information

Additional Information:
Responsible Party: Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00869531     History of Changes
Other Study ID Numbers: B223
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by University of Copenhagen:
Obesity
wholegrain
wheat
cardiovascular disease