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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT07036692
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures
* Adults aged ≥ 25 years
* Overweight as determined by a Body Mass Index \> 25 kg/m2
* Metabolic risk factor: at least one of the following criteria:
i. HbA1c ≥ 5.7% ii. Elevated liver enzymes (ALAT, ASAT, Gamma-Glutamyltransferase (gGT) at least one above normal range of the assay used in the respective laboratory) iii. LDL-cholesterol \> 3.0 mmol/l iv. Triglycerides \> 1.7 mmol/l
* Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
* Access to a scale to self-report weight
* Access and willing to use an electronic device (e.g., mobile phone, computer or tablet)
* Laboratory assessments of blood parameters were performed within a reasonable timeframe prior to the eligibility assessment, as determined by the PI.
Exclusion Criteria:
* Systemic antibiotic use within the last 2 months
* History of bariatric surgery
* Initiation or dose adjustment of pharmaceutical treatment for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)
* Use of prebiotic or probiotic supplementation (duration \>1 month) within the last 6 weeks (at PI's discretion, based on medication summary of TP)
* Medical weight management treatments within the last year (e.g., Glucagon-Like Peptide-1 (GLP-1) agonists)
* Recent (\<1 month) dose adjustment, initiation or termination of proton pump inhibitors use (e.g., pantoprazole, omeprazole)
* Professionally supervised intensive (\>6 months of ongoing supervision) weight management treatments (e.g., structured nutrition counselling) within the last year (at the PI's discretion)
* Diagnosis of Type 1 or Type 2 diabetes requiring bolus insulin therapy or frequent dose adjustments in base line insulin
* Regular alcohol consumption exceeding two (women) or three (men) standard units (10 g of pure alcohol) per day
* Consumption of more than one nicotine product (e.g., (e-)cigarette, gum) per month
* Regular drug abuse (once per week over the past 4 months)
* Any stage of known pregnancy or lactation period (self-reported)
* Active cancer or recent cancer treatment (within the last 4 months)
* Chronic, active inflammatory diseases (e.g., inflammatory bowel disease, rheumatoid arthritis)
* Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, gastroparesis)
* Known eating disorder (medically diagnosed)
* Participation in another investigation with an investigational drug within the 30 days preceding randomisation
* Dependency from the Sponsor-Investigator
* Last visit with TP \> 22 days prior to eligibility assessment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT07036692
Study Brief:
Protocol Section:
NCT07036692