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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT04417504
Eligibility Criteria:
Inclusion Criteria:
* Male or female;
* Born between 1981 and 1996;
* Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2;
* Normoglycemic according to American Diabetes Association criteria \[Fasting Plasma Glucose \< 100 mg/dl, 2-h plasma glucose value during a 75 g oral glucose tolerance test (OGTT) \< 140 mg/dl)\];
* Healthy.
Exclusion Criteria:
* Overweight or obese (BMI ≥ 25,0 kg/m2);
* Recent body weight loss/gain \>10%, within previous 3 months;
* Being on a weight loss/other special diet (e.g. Paleo diet, Atkins diet, flexitarian diet or ketogenic diet), within previous 3 months;
* Clinically significant illness, including:
type 1 or type 2 diabetes; liver disease e.g. cirrhosis; malignancy; pancreatitis or other malabsorption; gastrointestinal disorders e. g. intestinal bowel disorder, celiac disease; previous weight loss surgery e.g. bariatric surgery; chronic respiratory, neurological, psychiatric, musculoskeletal diseases/conditions; diagnosed eating disorders.
* Individuals who don't regularly consume breakfast;
* Having taken antibiotics within the 12 weeks prior to beginning the study;
* Taking other medication that could potentially affect body weight, glucose metabolism and/or appetite (e.g. GLP-1 analogues);
* Being engaged in competitive sports;
* Having \>14 or \>8 (males and females, respectively) alcoholic units/week; misuse of drugs;
* Having donated blood within one month prior to the beginning of the study;
* Nut or milk allergy, or other food allergy or intolerance that would compromise compliance with the study protocol;
* Pregnant or breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
23 Years
Maximum Age:
38 Years
Study:
NCT04417504
Study Brief:
Protocol Section:
NCT04417504