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:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT06745102
Eligibility Criteria:
Inclusion Criteria:
* BMI 25 - 29,9 kg/m²
as well as one or more of the following incipient metabolic diseases:
* pre-diabetes (fasting blood glucose 100-125 mg/dL),
* fatty liver (grade 1-3),
* high-normal blood pressure to mild hypertension (grade 1, systolic 140-159 mmHg)
Exclusion Criteria:
* History of diseases that could falsify the study results
* inflammatory bowel diseases
* malignant diseases of the gastrointestinal tract
* food allergies
* malabsorption
* kidney or liver disease (except simple fatty liver)
* symptomatic heart failure
* Taking medication to treat these diseases
* Consumption of special diets (e.g. vegan, gluten-free)
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06745102
Study Brief:
Protocol Section:
NCT06745102