Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction

NCT ID: NCT01176084

Last Updated: 2010-08-20

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-02-29

Brief Summary

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The purposes of this study are:

To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat.

To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.

Detailed Description

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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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low carbohydrate diet

Group Type EXPERIMENTAL

low carbohydrate diet

Intervention Type BEHAVIORAL

diet & exercise

Group Type EXPERIMENTAL

low carbohydrate diet and exercise

Intervention Type BEHAVIORAL

Interventions

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low carbohydrate diet

Intervention Type BEHAVIORAL

low carbohydrate diet and exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* male
* 21-65 years
* body mass index (BMI) 27-40kg/m2
* not currently losing weight
* physically able to exercise at moderate intensity
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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University of Surrey

Principal Investigators

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Rebecca Hiscutt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Helen D Truby, PhD

Role: STUDY_DIRECTOR

Monash University

Locations

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Faculty of Health and Medical Sciences, University of Surrey

Guildford, Surrey, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Lowcarbex_v1

Identifier Type: -

Identifier Source: org_study_id

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