NCT00868387

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
Last Updated

March 22, 2017

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

March 24, 2009

Last Update Submit

March 21, 2017

Conditions

Obesity

Keywords

weight reductionlow-carbohydratebody fattelemedicinecardiovascular risk markers

Outcome Measures

Primary Outcomes (1)

  • body weight

    12 months

Secondary Outcomes (5)

  • waist circumference

    12 months

  • blood pressure

    12 months

  • blood lipids

    12 months

  • parameters of glucose metabolism

    12 months

  • fat mass

    baseline, 12 months

Study Arms (2)

energy-restricted, CHO-restricted diet

EXPERIMENTAL

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

Other: energy-restricted, CHO-restricted diet

energy-restricted, CHO-rich diet

ACTIVE COMPARATOR

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

Other: energy-restricted, CHO-rich diet

Interventions

energy-restricted, CHO-restricted dietOTHER

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

energy-restricted, CHO-restricted diet
energy-restricted, CHO-rich dietOTHER

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

energy-restricted, CHO-rich diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-70 years
  • body mass index \> 27 kg/m2

You may not qualify if:

  • history of cardiovascular symptomatology
  • cholelithiasis
  • urolithiasis
  • insulin dependent diabetes
  • pacemaker implantation
  • pregnancy
  • lactation
  • vegetarianism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center North Rhine-Westfalia

Bad Oeynhausen, North Rhine-Westfalia, 32545, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19615091RESULT

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Heinrich Koertke, PhD

    Heart Center NRW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

November 1, 2005

Primary Completion

November 1, 2006

Study Completion

December 1, 2007

Last Updated

March 22, 2017

Record last verified: 2013-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)