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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT04203758
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* Age 30-70 y
* BMI 27-35 kg/m2
* Hemoglobin ≥117g/l for women and for men ≥134g/l
* Thyroid stimulating hormone (TSH) ≤4.30 mIU/L
* Low density lipoprotein (LDL) cholesterol ≤5.30 mmol/L
* Triglycerides ≤2.60 mmol/L
* Signed informed consent
Exclusion Criteria:
* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
* Unable to satisfactorily complete the 3-day weighted food record between screening visits.
* Unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period
* Increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period.
* Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
* Using e-cigarettes (regardless of nicotine content)
* Following any weight reduction program or having followed one during the last 6 months prior to visit 1.
* Diastolic blood pressure 105 mmHg or more at visit 1
* Systolic blood pressure 160 mmHg or more at visit 1
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* More than 10 hours physical activity per week
* History of heart failure or heart attack within 1 year prior to screening
* Having type I diabetes
* Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol)
* Previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening.
* Thyroid disorder
* History of eating disorder
* History of drug or alcohol abuse
* Stroke or transient ischemic attack (TIA) within 1 year prior to screening
* Consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician.
* Pregnant, lactation or planning a pregnancy within the timeframe of the study. Pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening.
* Food allergies or intolerances preventing consumption of any products included in the study
* Strict vegetarian (participants must be able to consume the standardized meals used for appetite assessment)
* Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
* Lack of suitability for participation in the study, for any reason, as judged by the medical doctor or PI.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT04203758
Study Brief:
Protocol Section:
NCT04203758