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

This study has been completed.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University of Surrey
ClinicalTrials.gov Identifier:
NCT01176084
First received: August 4, 2010
Last updated: August 19, 2010
Last verified: July 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   21 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Kathryn Hart, University of Surrey
ClinicalTrials.gov Identifier: NCT01176084     History of Changes
Other Study ID Numbers: Lowcarbex_v1
Study First Received: August 4, 2010
Last Updated: August 19, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013