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CompletedNCT00869531HEALTHGRAINUpdated Mar 26, 2009

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

An interventional study of wholegrain and refined wheat in Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-26.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • wholegrain
  • wheat
  • cardiovascular disease
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 85 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medication (hypertensive treatment not included)
  • BP > 160/100
  • Fasting glucose > 7mM
  • Fasting cholesterol > 6.5mM
  • Smoking
  • Known chronic illnesses
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    WW

    wholegrain wheat

    Other: wholegrain

  • Active comparator
    RW

    refined wheat

    Other: refined wheat

Interventions

  • Otherwholegrain

    wholegrain wheat vs. refined wheat products

  • Otherrefined wheat

    refined wheat products

06

What researchers measure

Primary outcomes

  1. Body weight and composition

    Time frame: 0, 6 and 12 wks

Secondary outcomes

  1. Cardiovascular risk markers

    Time frame: 0, 6 and 12 wks

  2. Fecal parameters

    Time frame: 0 and 12 wks

07

Study locations

1 site
  • University of Copenhagen, Department og Human Nutrition
    Frederiksberg C, 1958, Denmark
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00869531
Lead 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)
First posted
Mar 26, 2009
Start date
Aug 2007
Primary completion
Feb 2008
Completion
Dec 2008
Last update
Mar 26, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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