Effects of six weeks of omega 3-fatty acids, curcumin, and citicoline supplementation on cognitive function
Cognitive function
Screening: Potential study participants will undergo a phone screening using the study phone script to determine general eligibility. If they pass this initial screening, they will be invited to a familiarization session. If they do not pass, their data will be stored and safeguarded in the same manner as the data for those who do pass. Familiarization: During the familiarization, which will take approximately one hour, participants will be informed about the study, sign informed consent statements in compliance with University IRB, and complete a health history form included with the general screening form. Participants will respond to health history questionnaires and undergo a general health assessment including having height and weight measured on a calibrated scale, resting blood pressure (RBP) determined using a blood pressure cuff, and resting heart rate (RHR) measured. These measurements will be recorded on the General Screening Form and Case Report Form (Familiarization). Participants will next be informed of the general methods of the study and allowed to practice the COMPASS cognitive function tests. They will also be given instructions on how to complete the 4-day food log. Participants will be asked to record food and fluid intake for 4 days prior to testing, fast for 12 hours, avoid intense exercise for 24 hours, and refrain from consuming atypical amounts of caffeine and other stimulants not normally consumed in their diet for 48 hours prior to testing. Those eligible to participate will be scheduled for baseline assessments. Testing: The baseline testing session will take approximately one to two hours. Participants will first report to the Exercise & Sport Nutrition Lab (ESNL) and return their 4-day food log. Next, participants will be asked to complete a series of questionnaires including 1.) The Mini-Mental State Examination (MMSE). The MMSE is effective as a screening tool for cognitive impairment in older, community-dwelling, hospitalized, and
1. Must have the ability to complete the study, comply with the study procedures, consume the investigational product daily for the duration of the study, and provide voluntary written informed consent in English (i.e., English literacy) to participate in the study 2. Must have the ability to refrain from alcohol intake and ingesting caffeinated foods and beverages (chocolate, coffee, tea, energy drinks, etc.) 48-hours prior to each testing session 3. Must agree to abstain from dietary supplements (e.g., caffeine, gingko biloba, ashwagandha, paraxanthine, arginine, etc.) that may affect cognitive function during the study 4. Must have the ability to complete and understand the cognitive function practice tests in English (i.e., English literacy)
1. Known vitamin B12/B6 or folate deficiency 2. Known homocystinuria (a rare inherited metabolic disorder that prevents the body from processing the amino acid methionine) 3. High homocysteine levels (> 50 μmol/L) 4. A history of kidney disease requiring dialysis 5. Diagnosed with a cognitive impairment or neurological disease (e.g., Alzheimer’s disease, Parkinson’s disease, etc.) 6. Pregnant (confirmed via a negative pregnancy test for all female participants), breastfeeding, or wishing to become pregnant during the study 7. Uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease or medically treated major psychological or depressive disorder that may affect results of the study 8. A known allergy or are you sensitive to meat or fish (containing GAA and Cr) or any of the ingredients in the supplement products (GAA, Cr, Omega-3 fatty acids, curcumin, citicoline, and maltodextrin placebo) 9. Additional conditions which, in the PI’s opinion, may adversely affect your ability to complete the study, its measurements, or pose a significant risk