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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04120051
Eligibility Criteria:
Inclusion Criteria:
* Participants who have provided written informed consent
* Age between 30 and 65 years
* Body mass index ≥31 kg/m\^2
Exclusion Criteria:
* Body mass index \<31 kg/m\^2
* Diagnosis of diabetes (HbA1c ≥ 6,5% (48 mmol/mol)) or pharmacological treatment of diabetes
* Use of peroral glucocorticoids
* Lack of compliance with the procedures (ingestion of sachets) in the study protocol, judged by Investigator
* Ingestion of pre- or probiotic supplements during the study and 14 days prior to study start
* Use of systemic antibiotics 1 month prior to study start
* Use of cholesterol lowering drugs
* Have had an obesity or abdominal surgery
* Chronic inflammation disorders (excluding obesity)
* Diagnosed psychiatric disorder including depression requiring treatment
* Gastro intestinal and liver disorders
* Gluten intolerance
* Maltodextrin intolerance
* Intensive physical training/ elite athlete (\>10 hours of strenuous physical activity per week)
* Pregnant or lactating
* High intake of alcohol (\>14 drinks/week for women and \>21 drinks/week for men)
* Simultaneous blood donation for other purpose than this study
* Simultaneous participation in other clinical intervention studies
* Inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the principal investigator or clinical responsible.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT04120051
Study Brief:
Protocol Section:
NCT04120051