Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk

NCT ID: NCT00869531

Last Updated: 2009-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WW

wholegrain wheat

Group Type EXPERIMENTAL

wholegrain

Intervention Type OTHER

wholegrain wheat vs. refined wheat products

RW

refined wheat

Group Type ACTIVE_COMPARATOR

refined wheat

Intervention Type OTHER

refined wheat products

Interventions

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wholegrain

wholegrain wheat vs. refined wheat products

Intervention Type OTHER

refined wheat

refined wheat products

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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BARILLA G. e R. Fratelli S.p.A., Parma, Italy

UNKNOWN

Sponsor Role collaborator

European Commission

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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University of Copenhagen

Locations

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University of Copenhagen, Department og Human Nutrition

Frederiksberg C, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.healthgrain.org

EU project homepage

Other Identifiers

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B223

Identifier Type: -

Identifier Source: org_study_id

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