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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176084
• Other study ID #: Lowcarbex_v1
• Status: Completed
• Phase: N/A
• First received: August 4, 2010
• Last updated: August 19, 2010
• Start date: January 2004
• Est. completion date: February 2008

Study information

• Verified date: July 2010
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Behavioral:
• low carbohydrate diet

• low carbohydrate diet and exercise

Locations

Country	Name	City	State
United Kingdom	Faculty of Health and Medical Sciences, University of Surrey	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin levels
Secondary	body composition
Secondary	lipid profile
Secondary	body weight