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

Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00869531
Acronym
HEALTHGRAIN
Enrollment
85
Registered
2009-03-26
Start date
2007-08-31
Completion date
2008-12-31
Last updated
2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, wholegrain, wheat, cardiovascular disease

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.

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.

Interventions

OTHERwholegrain

wholegrain wheat vs. refined wheat products

refined wheat products

Sponsors

BARILLA G. e R. Fratelli S.p.A., Parma, Italy
CollaboratorUNKNOWN
European Commission
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Body weight and composition0, 6 and 12 wks

Secondary

MeasureTime frame
Cardiovascular risk markers0, 6 and 12 wks
Fecal parameters0 and 12 wks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026