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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT06842433
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* Age 40 to 70 years
* Body mass index (BMI) 27-35 kg/m2
* Signed informed consent
Exclusion Criteria:
* History of diagnosed cardiovascular disease (e.g. stroke, heart disease)
* Diagnosed type 1 or type 2 diabetes
* Finger prick glucose test at screening indicating diabetes (fasting \>6.9 mmol/L; non-fasting \>11.0 mmol/L)
* Antibiotic use in the last 3 months
* Taking medication that can interfere with the planned outcome measures, as judged by the study physician (e.g. peroxisome proliferator-activated receptor-α \[PPAR-α\] or PPAR-γ agonists \[fibrates\], sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin, chronic use of NSAIDs). Statins and hypertension medication are allowed if the medication regimen has been stable for the last three months
* Stomach and gastrointestinal conditions (e.g. Morbus Chron, Ulcerative colitis, irritable bowel syndrome, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* History of major gastrointestinal surgery
* Anaemia: Hb concentrations \< 8.5 mmol/L for men and \< 7.5 mmol/L for women
* Recent blood donation (within 2 months prior to the screening)
* Recent participation in another intervention study (within 2 months prior to the screening)
* Allergy or intolerance to medical skin adhesives
* Chronic or acute inflammatory conditions (e.g., rheumatoid arthritis, psoriatic arthritis)
* Autoimmune disorders
* Thyroid disorders
* Significant renal or liver dysfunction or chronic kidney or liver disease
* Known food allergies/intolerances to intervention foods or food products used in the study
* Following specific dietary regimen that could impact results or not suitable for the study design (e.g. vegetarian, vegan)
* Habitual tobacco consumption (e.g. smoking, use of snus, vaping)
* Alcohol intake ≥ 14 alcoholic beverages/week for women and ≥ 21 alcoholic beverages/week for men
* Current or planned pregnancy or lactating
* Other serious medical conditions that could interfere with participation or study outcomes
* Unable to sufficiently understand written and spoken national language (where the study centre is located) to provide written consent and understand information and instructions from the study personnel.
* Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or PI.
* Working at the division conducting the trial at any of the three study centres.
* Do not have a mobile phone that is suitable for the use of a research app.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06842433
Study Brief:
Protocol Section:
NCT06842433