Macronutrient Relations and Weight Loss in Obese Subjects

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868387
• Other study ID #: 003
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: March 21, 2017
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: December 2013
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see brief summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• energy-restricted, CHO-restricted diet
carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months
• energy-restricted, CHO-rich diet
carbohydrate content of diet > 55% Frequency: daily Duration: 12 months

Locations

Country	Name	City	State
Germany	Heart Center North Rhine-Westfalia	Bad Oeynhausen	North Rhine-Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		12 months
Secondary	waist circumference		12 months
Secondary	blood pressure		12 months
Secondary	blood lipids		12 months
Secondary	parameters of glucose metabolism		12 months
Secondary	fat mass		baseline, 12 months