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

August 19, 2010 updated by: University of Surrey

The Efficacy of a Low Carbohydrate Diet, With and Without Exercise, on Cardiovascular Disease Risk in Obese Men

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XH
        • Faculty of Health and Medical Sciences, University of Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low carbohydrate diet
Behavioral: low carbohydrate diet
Experimental: diet & exercise
Behavioral: low carbohydrate diet and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
insulin levels

Secondary Outcome Measures

Outcome Measure
body composition
body weight
lipid profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: Rebecca Hiscutt, PhD, University of Surrey
  • Study Director: Helen D Truby, PhD, Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

August 4, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

August 20, 2010

Last Update Submitted That Met QC Criteria

August 19, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lowcarbex_v1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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