| Eligibility |
Inclusion Criteria:
- Subjects with Mini-Mental State Examination (MMSE) score > 23 indicating a healthy
cognitive state.
- Subjects with Adult Memory Questionnaire (AMQ) score of 40-70% indicating subjective
memory lapse.
- Subjects with T score on 8-item Patient-Reported Outcomes Measurement Information
System (PROMIS) Depression Short Form: 50.0-59.9 (mild) as per Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) criteria.
- Males and Females of Age 18 - 60 years will be selected for the study.
- Subject who is willing to maintain his or her habitual diet and usual physical
activity patterns throughout the study.
- Subject who has no health conditions that would prevent him/her from fulfilling the
study requirements as judged by the Investigator on the basis of medical history and
routine laboratory test results.
- Subject should be willing to refrain from consuming alcohol 24 h prior to the test
days.
- Subject should be willing to refrain from consuming caffeine and caffeine-containing
products 12 h prior to test days.
- Subject should be willing to refrain from vigorous physical activity 12 h prior to
test days.
- Subject should be a non-smoker.
- Subject who understands the study procedures and signs forms providing informed
consent to participate in the study and authorization for release of relevant
protected health information to the study Investigator.
Exclusion Criteria:
- Subjects with MMSE score = 23 indicative of clinical dementia.
- Subjects with AMQ score <40 and >70 %.
- T score on 8-item PROMIS Depression Short Form <50 (normal) and =60 (moderate and
severe).
- Confirmed diagnosis of dementia/ Alzheimer's disease.
- Current evidence of hearing impairment or other information processing impairment.
- Subjects who are using amphetamines, barbiturates, benzodiazepines, cannabis, cocaine,
methamphetamines, methadone, 3,4-methylenedioxymethamphetamine, opiates or tricyclic
antidepressants, as disclosed at the screening visit.
- Subjects with uncontrolled hypertension (systolic blood pressure =160 mm Hg or
diastolic blood pressure =100 mm Hg) as defined by the average blood pressure measured
at the screening.
- Subjects with a history or presence of clinically important cardiac, renal, hepatic,
endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal,
pancreatic, or neurologic disorders that, in the judgment of the Investigator, would
interfere with the subject's ability to provide informed consent, comply with the
study protocol (which might confound the interpretation of the study results), or put
the subject at undue risk.
- Subject with a history, in the judgment of the Investigator, of a psychological
illness or condition such as to interfere with the subject's ability to understand the
requirements of the study or which could significantly influence cognitive abilities.
- Use of any sleep aid medication.
- Pregnant female subjects or planning to be pregnant during the study period,
lactating, or women of childbearing potential who are unwilling to commit to the use
of a medically approved form of contraception throughout the study period. The method
of contraception must be recorded in the source documentation.
- Excessive habitual caffeine consumption (>300 mg caffeine/d or =3 cups of caffeinated
coffee/d), following screening and throughout the study period.
- Use of any psychotropic medication within four weeks of screening and throughout the
study.
- Use of antibiotics or signs of active systemic infection. Treatment visits will be
rescheduled to allow the subject to wash off of the antibiotic for at least five days
prior to any test visit.
- Subject who has had exposure to any non-registered drug product within 30 days prior
to the screening visit.
- Subjects who are using any dietary supplements and or containing any of the
ingredients of the investigational product.
- Recent history of (within 12 months of screening visit 1) or strong potential for
alcohol or substance abuse.(Alcohol abuse is defined as >14 drinks per week.)
- Subject who has a known allergy or sensitivity to the study product or any ingredients
of the study product or meals provided.
- The subject is unable to perform the tests on the computer for participation in this
type of study.
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