NCT00869531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

March 25, 2009

Last Update Submit

March 25, 2009

Conditions

Obesity

Keywords

Obesitywholegrainwheatcardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Body weight and composition

    0, 6 and 12 wks

Secondary Outcomes (2)

  • Cardiovascular risk markers

    0, 6 and 12 wks

  • Fecal parameters

    0 and 12 wks

Study Arms (2)

WW

EXPERIMENTAL

wholegrain wheat

Other: wholegrain

RW

ACTIVE COMPARATOR

refined wheat

Other: refined wheat

Interventions

wholegrainOTHER

wholegrain wheat vs. refined wheat products

WW
refined wheatOTHER

refined wheat products

RW

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department og Human Nutrition

Frederiksberg C, 1958, Denmark

Location

Related Links

MeSH Terms

Conditions

ObesityCardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

August 1, 2007

Primary Completion

February 1, 2008

Study Completion

December 1, 2008

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

DK(1)