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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06889961
Eligibility Criteria:
Inclusion Criteria:
1. Participants are required to have clinical histories consistent with normal aging or mild cognitive impairment (MCI).
2. Age 50 to 80 years.
3. Adequate visual acuity and hearing to allow neuropsychological testing.
4. Screening laboratory tests without significant abnormalities that might interfere with the study.
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Exclusion Criteria:
1. Diagnosis of probable Alzheimer's disease or any other dementia (e.g. vascular, Lewy body, frontotemporal)
2. Evidence of other neurological or physical illness that can produce cognitive deterioration. Determination of dementia will be based on the clinical evaluation including assessment of functional abilities, and cognitive screening (using the Mini Mental State Examination
3. Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale \[38\].
4. Uncontrolled hypertension (systolic blood pressure (BP) \> 170 or diastolic BP \> 100).
5. Consume spices regularly \> 5g day
6. Allergy or sensitivity to spices. Subjects will be excluded if there is a prior history of such sensitivity. Since these foods are commonly eaten and allergies are rare, subjects should be aware of this sensitivity prior to entering the study. To determine this, a positive history of spices ingestion without incident will be requested. In addition, any subject with a history of allergy or anaphylaxis of any kind will be excluded.
7. Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
8. Current diagnosis or alcoholism or substance addiction.
9. Eating a high fiber/polyphenol diet or taking any medication or dietary supplement which interfere with the absorption of polyphenols.
10. Frequently using prebiotics, probiotics, yogurt, and/or any fiber supplements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT06889961
Study Brief:
Protocol Section:
NCT06889961