Macronutrient Relations and Weight Loss in Obese Subjects

Study Overview
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Brief Summary
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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
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see brief summary.

Official Title
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Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program

Conditions
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Obesity

Intervention / Treatment
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* Other: energy-restricted, CHO-restricted diet
* Other: energy-restricted, CHO-rich diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: energy-restricted, CHO-restricted diet<br>Interventions: carbohydrate restriction of diet: 40% Frequency: daily Duration: 12 months | Other: energy-restricted, CHO-restricted diet<br>* carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months<br>|
| Active Comparator: energy-restricted, CHO-rich diet<br>Comparator: carbohydrate content of diet: > 55% Frequency: daily Duration: 12 months | Other: energy-restricted, CHO-rich diet<br>* carbohydrate content of diet > 55% Frequency: daily Duration: 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference |  | 12 months | 
| blood pressure |  | 12 months | 
| blood lipids |  | 12 months | 
| parameters of glucose metabolism |  | 12 months | 
| fat mass |  | baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight reduction, low-carbohydrate, body fat, telemedicine, cardiovascular risk markers