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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04192357
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 to 65 years
* BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
* Interested in being enrolled in a weight loss program
* Available to comply with study protocol and sign informed consent
Exclusion Criteria:
* Pregnant, breastfeeding or planning to become pregnant within the study period.
* Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
* Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
* Subjects with renal impairment
* Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
* Subjects with autoimmune diseases and/or chronic use of corticosteroids.
* Use of weight loss medications/other nutritional supplements
* Subjects with psychiatric or neurological illness
* Subjects sensitive to any component of supplements
* Subjects with surgery or hospitalization in the last 30 days
* Subjects prescribed with 5 or more drugs
* Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study
* Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)
* Subjects with history of drug, alcohol or other substances abuse.
* Eating behavior disorders
* Pacemaker carrier
* Urinary incontinence
* Vegetarians or vegans
* Subjects underwent bariatric surgery
* Type 1 or type 2 diabetes mellitus
* Altered blood clotting
* Severe heart failure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04192357
Study Brief:
Protocol Section:
NCT04192357