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

This study has been completed.
Sponsor:
Collaborators:
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)
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00869531
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention
Obesity
 Other: wholegrain
Other: refined wheat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Body weight and composition [ Time Frame: 0, 6 and 12 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular risk markers [ Time Frame: 0, 6 and 12 wks ] [ Designated as safety issue: No ]
  • Fecal parameters [ Time Frame: 0 and 12 wks ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WW
wholegrain wheat
 Other: wholegrain
wholegrain wheat vs. refined wheat products
Active Comparator: RW
refined wheat
 Other: refined wheat
refined wheat products

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
EU project homepage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00869531     History of Changes
Other Study ID Numbers: B223
Study First Received: March 25, 2009
Last Updated: March 25, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013