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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT05513404
Eligibility Criteria:
Inclusion Criteria:
* Healthy men or post-menopausal women
* Aged ≥40 and ≤ 70 years old.
* BMI ≥ 18.5 kg/m2
* HbA1c \<6.5%
Neuropsychological screening tasks will include the Mini-Mental State Examination (MMSE), the National Adult Reading Test (NART), the Geriatric Depression Scale (GDS), the Trail Making Test (TMT), the Controlled Oral Word Association Test (COWAT), the Hopkins Verbal Learning Test (HVLT),
* MMSE \>= 27
* NART, TMT, COWAT and HVLT within acceptable norms
Exclusion Criteria:
* Exclusion Criteria
Those with any of the following will be excluded from participation:
We will ask the volunteers to complete a questionnaire to state current health complaints and current medication use.
Chronic illness, including: thromboembolic or coagulation disease unregulated thyroid disease kidney disease hepatic disease severe gastrointestinal disorders pulmonary disease (e.g. chronic bronchitis, COPD, pacemaker implant) Alcohol or any other substance abuse Eating disorders a history of neurological abnormalities, Women who are lactating or breastfeeding, pregnant Allergic/intolerant to foods provided in the study (Fruit allergy). Alcohol and/or other substance abuse Smoking and the use of e-cigarettes Physically active at a competitive level (exercising strenuously on a daily basis for long periods of time)
Medication exclusion criteria Oral steroids Tricyclic antidepressants, neuroleptics Anticoagulants Digoxin and anti-arrhythmics Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin. Chronic use of anti-inflammatories (e.g. \> 200mgs doses of aspirin, ibuprofen), current psycho-active medication chlorphenamine
Neuropsychological exclusion criteria
* MMSE \< 27
* GDS \> 5
* Self-report of prior diagnosis of dementia, probable dementia, or mild cognitive impairment
* History of stroke, severe head injury or other neurological condition which may adversely affect cognition
* history of anxiety and depression
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT05513404
Study Brief:
Protocol Section:
NCT05513404