Macronutrient Relations and Weight Loss in Obese Subjects

H

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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