Macronutrient Relations and Weight Loss in Obese Subjects - Full Text View

Sponsored by:	Heart and Diabetes Center North-Rhine Westfalia
Information provided by:	Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:	NCT00868387

Purpose

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.

Condition	Intervention
Obesity	Other: energy-restricted, carbohydrate-restricted diet Other: energy-restricted, fat-restricted diet

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Effects of Macronutrient Relations on Body Weight, Body Composition, and Cardiovascular Risk Markers in Overweight Patients Attending a Telemedically Guided Weight Loss Program

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:

body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
fat mass [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

waist circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
blood lipids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
parameters of glucose metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	200
Study Start Date:	November 2005
Study Completion Date:	December 2007
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
carbohydrate restriction: Experimental Interventions: carbohydrate content of diet: < 40% Frequency: daily Duration: 12 months	Other: energy-restricted, carbohydrate-restricted diet carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
fat restriction: Active Comparator Interventions: carbohydrate content of diet > 55% Frequency: daily Duration: 12 months	Other: energy-restricted, fat-restricted diet carbohydrate content of diet > 55% Frequency: daily Duration: 12 months

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868387

Locations

Germany, North Rhine-Westfalia
Heart Center North Rhine-Westfalia
Bad Oeynhausen, North Rhine-Westfalia, Germany, 32545

Sponsors and Collaborators

Heart and Diabetes Center North-Rhine Westfalia

Investigators

Principal Investigator:

Heinrich Koertke, PhD

Heart Center NRW

More Information

No publications provided by Heart and Diabetes Center North-Rhine Westfalia

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Frisch S, Zittermann A, Berthold HK, Götting C, Kuhn J, Kleesiek K, Stehle P, Körtke H. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program. Cardiovasc Diabetol. 2009 Jul 18;8:36.

Responsible Party:	Heart Center NRW ( Heinrich Koertke, PhD )
Study ID Numbers:	003
Study First Received:	March 24, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00868387 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:

weight reduction
low-carbohydrate
body fat
telemedicine
cardiovascular risk markers

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on September 09, 2009