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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT05306093
Eligibility Criteria:
Inclusion Criteria:
* Adults aged between 20 and 65 years (limits included);
* Body Mass Index (BMI) ≥19 and \< 30 kg/m²;
* Considered healthy based on their medical history and clinical examination;
* Subjects self-reporting anhedonia based on SHAPS questionnaire. Score ≥ 3 allows the inclusion;
* Subjects with depressive mood disturbance based on POMS depression subscale. Score ≥ 4 allows the inclusion;
* Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form;
* Affiliated with a social security scheme;
* Agreeing to be registered on the national file of the volunteers in biomedical research.
Exclusion Criteria:
* Suffer from mental health other than mild depressive or anxiety symptoms as measured by the Patient Health Questionnaire (PHQ-9). Volunteers with PHQ-9 score \>14 could not be included;
* Having suicidal thoughts: score ≥1 at the item 9 of the PHQ-9;
* Diagnosis of medical or psychiatric conditions including (but not limited to):
* psychiatric disorder (other than mild-to-moderate depression symptoms, anhedonia or anxiety),
* neurological disease (Parkinson's, Alzheimer's disease, intracranial haemorrhage, head or brain injury),
* cancer/malignancy,
* cardiovascular disease (other than hypertension),
* Immunological disease,
* endocrine disease (including diabetes or thyroid diseases, Chronic kidney disease, hematological abnormalities);
* Smokers (more than 5 cigarettes per day);
* Uncontrolled hypertension with medication (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) or without medication (SBP ≥ 140mmHg or DBP ≥ 90 mmHg);
* Taking drugs (anxiolytics, antidepressants, antihistamine drug more than 7 day/month) known to have an impact on mental health in the month preceding inclusion and / or likely to consume them during the study and/or Illicit drug;
* Undergoing a psychotherapy in the month preceding inclusion or during the study;
* Consuming more than 3 standard drinks of alcoholic beverage daily;
* Weight change above 10% body weight within the past 6 months before inclusion;
* Currently under prescribed diet regimen, whatever the reason;
* Consuming foods supplement known to have an influence on mental health in the month preceding the inclusion and / or likely to take during the study;
* Consuming more than 50g of chocolate/day;
* For females: Pregnant or planning pregnancy during the study or breastfeeding;
* Any intolerance or allergy documented or suspected to one of the components of the study products;
* Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
* Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study;
* Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
* Presenting a psychological or linguistic incapability to sign the informed consent and to answer the study questionnaires
* Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT05306093
Study Brief:
Protocol Section:
NCT05306093