Macronutrient Relations and Weight Loss in Obese Subjects

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: energy-restricted, CHO-restricted diet; Other: energy-restricted, CHO-rich diet

• Registration Number: NCT00868387
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief Summary

The burden of overweight and obesity has dramatically increased during the last decades. High carbohydrate intake, particularly refined carbohydrates, probably increase the risk of obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy of weight loss programs depends on care and control. The investigators aim to investigate whether or not a carbohydrate-restricted telemedically guided weight loss program results in a more pronounced weight loss and influences metabolic risk markers more beneficial than a fat-restricted diet.

Detailed Description

see brief summary.

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-11
• Study Completion: 2007-12
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Status Verified: 2013-12
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age 18-70 years
• body mass index > 27 kg/m2

Exclusion Criteria

• history of cardiovascular symptomatology
• cholelithiasis
• urolithiasis
• insulin dependent diabetes
• pacemaker implantation
• pregnancy
• lactation
• vegetarianism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
energy-restricted, CHO-restricted diet	energy-restricted, CHO-restricted diet	Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months
energy-restricted, CHO-rich diet	energy-restricted, CHO-rich diet	Comparator: carbohydrate content of diet: \> 55% Frequency: daily Duration: 12 months

Primary Outcome Measures

Name	Time	Method
body weight	12 months

Secondary Outcome Measures

Name	Time	Method
fat mass	baseline, 12 months
waist circumference	12 months
blood pressure	12 months
blood lipids	12 months
parameters of glucose metabolism	12 months

Trial Locations

Locations (1)

Heart Center North Rhine-Westfalia; 🇩🇪 Bad Oeynhausen, North Rhine-Westfalia, Germany