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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01176084
First Posted: August 5, 2010
Last Update Posted: August 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Heart Foundation
Information provided by:
University of Surrey
  Purpose

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.


Condition Intervention
Obesity Behavioral: low carbohydrate diet Behavioral: low carbohydrate diet and exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a Low Carbohydrate Diet, With and Without Exercise, on Cardiovascular Disease Risk in Obese Men

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • insulin levels

Secondary Outcome Measures:
  • body composition
  • lipid profile
  • body weight

Enrollment: 56
Study Start Date: January 2004
Study Completion Date: February 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low carbohydrate diet Behavioral: low carbohydrate diet
Experimental: diet & exercise Behavioral: low carbohydrate diet and exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • 21-65 years
  • body mass index (BMI) 27-40kg/m2
  • not currently losing weight
  • physically able to exercise at moderate intensity
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176084


Locations
United Kingdom
Faculty of Health and Medical Sciences, University of Surrey
Guildford, Surrey, United Kingdom, GU2 7XH
Sponsors and Collaborators
University of Surrey
British Heart Foundation
Investigators
Principal Investigator: Rebecca Hiscutt, PhD University of Surrey
Study Director: Helen D Truby, PhD Monash University
  More Information

Responsible Party: Dr Kathryn Hart, University of Surrey
ClinicalTrials.gov Identifier: NCT01176084     History of Changes
Other Study ID Numbers: Lowcarbex_v1
First Submitted: August 4, 2010
First Posted: August 5, 2010
Last Update Posted: August 20, 2010
Last Verified: July 2010

Keywords provided by University of Surrey:
low carbohydrate diet
obesity
moderate exercise
men

Additional relevant MeSH terms:
Cardiovascular Diseases