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 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT07035704
Eligibility Criteria:
Inclusion Criteria:
* 18-55 years old overweight or obese men and women (BMI ≥ 25 kg/m2).
* Signed informed consent.
* Have a mobile phone, tablet, or computer with internet access.
Exclusion Criteria:
* Waist circumference \> 150 cm
* Suffer from diabetes or other disorders of glucose metabolism
* Suffer from dyslipidemia or other alterations of lipid metabolism (LDL cholesterol ≥ 189 mg/dL and/or triglycerides ≥ 350 mg/dL).
* Present chronic gastrointestinal problems such as Crohn's disease or irritable bowel syndrome.
* Present any chronic or autoimmune disease in clinical manifestation such as hepatitis, hyper or hypothyroidism or metabolic diseases.
* Have a diagnosed liver disease other than steatotic liver disease.
* Taking supplements or multivitamin supplements or phototherapeutic products for weight loss that interfere with the study.
* Have taken antibiotics in the last 30 days.
* Follow a low-calorie diet and/or pharmacological treatment for weight loss.
* Being a smoker.
* Regular alcohol consumption (more than 4 Standard Drink Units (SDU) per day or 28 SDU per week.
* Have lost more than 3 kg of weight in the last 3 months.
* Suffering from eating disorders or psychiatric disorders.
* Present food intolerances and/or allergies related to the study products, such as allergy to edible mushrooms or fungal spores or to any of the components of the Lebanese herbal mixture Za'atar such as sesame seeds.
* Be pregnant or intend to become pregnant or be breastfeeding,
* Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
* No or limited access to the Internet.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07035704
Study Brief:
Protocol Section:
NCT07035704