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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT03526120
Eligibility Criteria:
Inclusion Criteria:
1. Healthy women;
2. Age: lower age limit 18 years, upper age limit: 50 years (included);
3. Body Mass Index: lower limit 19 kg/m²; upper limit 29.9 kg/m²; weight stable within ± 2 kg in the last 3 months;
4. Habitual energy intake, as indicated by an initial intake report (diary method, three days) within the 95% confidence interval (CI) of the habitual energy intake of a similar population (as provided by internal reference data collected by CREABio-RA from previous studies in similar conditions);
5. Participant not pregnant, not presently breast feeding or having breastfed in the last 3 months, and not planning to become pregnant during the study (negative pregnancy test at inclusion or morning of V1);
6. Pre-menopausal participant on effective contraception since at least 3 months (regular 28-day cycle) and who agree to continue their contraception throughout the study;
7. Participant registered with the French Social Security;
8. participant having signed informed consent
Exclusion Criteria:
1. Subject under legal protection or deprived of liberty by judicial or administrative decision.
2. Currently diagnosed somatic pathology;
3. On medication affecting metabolism, weight, energy intake, or energy expenditure in the last 6 months;
4. Major psychiatric disorder, particularly eating disorders as defined by the DSM-V;
5. High level of "Restrained Eating" or "Disinhibition", as revealed by the TFEQ or similar questionnaire;
6. Strong initial dislike of nuts, specially pistachios, as revealed by questioning about food habits initial dietary questionnaire;
7. Habitual consumption of pistachios as revealed by the 3-d intake report (more than twice a week);
8. Participants smoking more than 10 cigarettes per day or planning to stop smoking in the next 3 months;
9. Currently pregnant, lactating (as specified in article L1121-5 of the Public Health Code) or less than 6 month post-partum;
10. Any kind of food allergy, especially allergies or intolerance to nuts;
11. Participant not capable of understanding the constraints of the study, who does not agree to abide, and/or unable to communicate normally with investigators;
12. Person currently participating in another clinical study, or having used up her annual entitlement to compensation for participation in biomedical studies (4500 €).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03526120
Study Brief:
Protocol Section:
NCT03526120