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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT01965795
Eligibility Criteria:
Inclusion Criteria:
* Age: Participants must be 45-55 years old. Investigators have selected an age range of 40-55 years to enhance the chance of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is expected to be higher, may perform at a ceiling level, with less room for improvement by the product under study. An emerging body of data suggests speculation that natural polyphenols can combat age-related cognitive decline, which is often accompanied by depression and potentially by reduced levels of hippocampal neurogenesis (Ogle et al., 2013).
* Language: Subjects must be fluent in English (in order to provide consent, complete questionnaires,\& cognitive testing)
* BMI: Body mass index values ≥ 18 kg/m2 and ≤ 25 kg/m2
* Vital signs: must be within the clinically acceptable normal range (i.e., resting pulse between 50 and 90 beats/min (bpm), blood pressures between 85-150 mm Hg systolic and 45-90 mm Hg diastolic
* Pregnancy prevention: if female, must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal,) or agree to use a reliable form of contraception (e.g., birth control pills, intrauterine device, condoms, or spermicide) during the trial and to provide a negative pregnancy urine test before randomization.
Exclusion Criteria:
* Certain medical conditions: Participants may not have a medical condition that, in the study physician's judgment, may interfere with safe participation (e.g., active tuberculosis, unstable cardiac, renal, pulmonary or liver disease, unstable diabetes)
* Neurological disorder: Participants should not have a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make compliance difficult or would compromise informed consent
* Psychiatric disorder: must not have an Axis I psychiatric disorder as assessed by the Structured Clinical Inventory for DSM-IV-TR (SCID)
* Suicide Attempt(s): Participants may not have a history of attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past month as assessed by the SCID
* Prescription medications: must not be taking a prescription medication that can affect brain function
* Alcohol dependence: Must not have a history of alcohol dependence within the past 3 years
* Pregnancy or nursing
* Heart abnormality: Participants should not have a clinically significant heart disease or hypertension; ECG showing cardiac ischemia or other clinically significant abnormality
* Smoking: Participants must be current non-smokers
* Illicit drug use: Participants must not have a current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR
* Other: Participants may not have any other circumstance that, in the opinion of investigators, would compromise safety
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT01965795
Study Brief:
Protocol Section:
NCT01965795