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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT06511206
Eligibility Criteria:
Inclusion Criteria:
* Aged 60-80 years
* Body mass index (BMI) 25-35 kg/m2
* Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months)
* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
Exclusion Criteria:
* Type 2 diabetes
* Pre-diabetes based on one or a combination of the following criteria:
* ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
* HbA1c of 5.7-6.4%.
* Participants with active congestive heart failure and/or severe renal and or liver insufficiency
* Uncontrolled hypertension
* Alcohol consumption of \> 3 servings per day for man and \> 2 servings per day for woman
* Unstable body weight (weight gain or loss \> 5 kg in the last 3 months)
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
* Significant food allergies/intolerance (seriously hampering study meals)
* Participants who do not want to be informed about unexpected medical findings
* Blood donation during or within 2 months prior to the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT06511206
Study Brief:
Protocol Section:
NCT06511206