Effect of Wholegrain Wheat on Body Weight and Composition... | NCT00869531

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

NCT00869531

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Mar 26, 2009Estimated

Enrollment

85Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

wholegrain
refined wheat

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 25, 2009

First Submission Date that Met QC Criteria

Mar 25, 2009

First Posted Date

Mar 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2009

Last Update Posted Date

Mar 26, 2009Estimated

Name	Class
BARILLA G. e R. Fratelli S.p.A., Parma, Italy	UNKNOWN
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WW	Experimental	wholegrain wheat	Other: wholegrain
RW	Active Comparator	refined wheat	Other: refined wheat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
wholegrain	Other	wholegrain wheat vs. refined wheat products	WW
refined wheat

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen, Department og Human Nutrition		Frederiksberg C		1958	Denmark

Label	URL
EU project homepage	View source

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided