Macronutrient Relations and Weight Loss in Obese Subjects

NCT ID: NCT00868387

Last Updated: 2017-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-12-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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energy-restricted, CHO-restricted diet

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

Group Type EXPERIMENTAL

energy-restricted, CHO-restricted diet

Intervention Type OTHER

carbohydrate content of the diet \< 40% Frequency: daily Duration: 12 months

energy-restricted, CHO-rich diet

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

Group Type ACTIVE_COMPARATOR

energy-restricted, CHO-rich diet

Intervention Type OTHER

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

Interventions

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energy-restricted, CHO-restricted diet

carbohydrate content of the diet \< 40% Frequency: daily Duration: 12 months

Intervention Type OTHER

energy-restricted, CHO-rich diet

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heinrich Koertke, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Center NRW

Locations

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Heart Center North Rhine-Westfalia

Bad Oeynhausen, North Rhine-Westfalia, Germany

Site Status

Countries

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Germany

References

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Frisch S, Zittermann A, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Kortke 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. doi: 10.1186/1475-2840-8-36.

Reference Type RESULT
PMID: 19615091 (View on PubMed)

Other Identifiers

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003

Identifier Type: -

Identifier Source: org_study_id

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