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CompletedNCT00868387Updated Mar 22, 2017

Macronutrient Relations and Weight Loss in Obese Subjects

An interventional study of energy-restricted, CHO-restricted diet and energy-restricted, CHO-rich diet in Obesity, sponsored by Heart and Diabetes Center North-Rhine Westfalia. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Heart and Diabetes Center North-Rhine Westfalia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

see brief summary.

02

Conditions studied

  • Obesity

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Keywords

  • weight reduction
  • low-carbohydrate
  • body fat
  • telemedicine
  • cardiovascular risk markers
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 200 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia is the lead sponsor of 33 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of cardiovascular symptomatology
  • cholelithiasis
  • urolithiasis
  • insulin dependent diabetes
  • pacemaker implantation
  • pregnancy
  • lactation
  • vegetarianism
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    energy-restricted, CHO-restricted diet

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

    Other: energy-restricted, CHO-restricted diet

  • Active comparator
    energy-restricted, CHO-rich diet

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

    Other: energy-restricted, CHO-rich diet

Interventions

  • Otherenergy-restricted, CHO-restricted diet

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

  • Otherenergy-restricted, CHO-rich diet

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

06

What researchers measure

Primary outcomes

  1. body weight

    Time frame: 12 months

Secondary outcomes

  1. waist circumference

    Time frame: 12 months

  2. blood pressure

    Time frame: 12 months

  3. blood lipids

    Time frame: 12 months

  4. parameters of glucose metabolism

    Time frame: 12 months

  5. fat mass

    Time frame: baseline, 12 months

07

Study locations

1 site
  • Heart Center North Rhine-Westfalia
    Bad Oeynhausen, North Rhine-Westfalia 32545, Germany
08

References and documents

Publications

  • 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. PubMed 19615091 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00868387
Lead sponsor
Heart and Diabetes Center North-Rhine Westfalia
Responsible party
Sponsor
First posted
Mar 25, 2009
Start date
Nov 2005
Primary completion
Nov 2006
Completion
Dec 2007
Last update
Mar 22, 2017

Study contacts

Heinrich Koertke, PhD
principal investigator · Heart Center NRW

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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