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

March 25, 2009 updated by: University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg C, Denmark, 1958
        • University of Copenhagen, Department og Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight and composition
Time Frame: 0, 6 and 12 wks
0, 6 and 12 wks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular risk markers
Time Frame: 0, 6 and 12 wks
0, 6 and 12 wks
Fecal parameters
Time Frame: 0 and 12 wks
0 and 12 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 26, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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