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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT02770833
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women
* Between 18 and 50 years of age
* BMI between 25.0 and 30.0 kg×m-2
* Fasting blood glucose \< 5.9 mmol/L (measured at the screenings visit)
* Non-smoker
Exclusion Criteria:
* Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
* Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
* Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
* Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
* Menopausal women and women with an irregular menstrual cycle
* Food allergies
* Substance abuse
* Vigorous physical activity more than 10 hours/week
* Alcohol intake above the recommendations from the Danish Health and Medicines Authority
* Caffeine intake above 300 mg/day
* Night- or shift work
* Blood donation \<1 month before study commencement and during study period
* Simultaneous participation in other clinical studies
* Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
* Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02770833
Study Brief:
Protocol Section:
NCT02770833