Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT00579657
Eligibility Criteria:
Inclusion Criteria:
* Waist \> 80 cm (females) or \> 94 cm (males)
* BMI \> 25 kg/m²
* IFG, IGT, or insulin resistance; and/or dyslipidemia; and/or high blood pressure
* Willingness to comply with one of the randomly assigned diets over the study period
Exclusion Criteria:
* Diabetes type 1 and type 2
* Pregnancy
* Allergies including food allergies
* Metal implants
* Chronic disease of heart, kidney, or liver
* Relevant deviation of body weight during isoenergetic 6-weeks period (+/- 3 kg)
* Intake of drugs with known impact on whole-body insulin sensitivity during the study (e.g. cortisone, ASS, antibiotics)
* Missing data about primary outcome measures (Clamp data, data about dietary intake from food diaries or 3-day food protocols)
* Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period (e.g. significant deviation from 30% target for dietary fat in all groups, intake of a low protein or low fiber diet in the high protein or high fiber groups, respectively)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Years
Maximum Age:
70 Years
Study:
NCT00579657
Study Brief:
Protocol Section:
NCT00579657