Macronutrient Relations and Weight Loss in Obese Subjects

Heart and Diabetes Center North-Rhine Westfalia

Status: Completed

Conditions: Obesity

Treatments: Other: energy-restricted, CHO-rich diet; Other: energy-restricted, CHO-restricted diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00868387

003

Details and patient eligibility

About

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.

Full description

see brief summary.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

energy-restricted, CHO-restricted diet

Experimental group

Description:

Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months

Treatment:

Other: energy-restricted, CHO-restricted diet

energy-restricted, CHO-rich diet

Active Comparator group

Description:

Comparator: carbohydrate content of diet: \> 55% Frequency: daily Duration: 12 months

Treatment:

Other: energy-restricted, CHO-rich diet