Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
95
Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days
Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days
Aspen Clinical Research
Orem, Utah, United States
Determine effects of investigational supplement on gene expression profiles.
Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel
Time frame: Day 0, Day 28, Day 56
Establish a safety profile of investigational supplement
Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline.
Time frame: Day 0, Day 28, Day 56
Determine effects of investigational supplement on markers of inflammation
Time frame: Day 0, Day 28, Day 56
Determine effects of investigational supplement on composite cognitive index
Time frame: Day 0, Day 28, Day 56
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)
Questionnaire: Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 0, Day 28, Day 56
Determine changes in Quality of Life
SF-36 (Quality of Life Assessment)
Time frame: Day 0, Day 28, Day 56
Determine changes in sleep patterns and quality
Sleep measurement scale.
Time frame: Day 0, Day 28, Day 56
Determine changes to overall health
Abbreviated Physical Exam
Time frame: Day 0, Day 28, Day 56
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Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)
Digital Pulse Wave Analyzer
Time frame: Day 0, Day 28, Day 56
Determine changes in Biophotonic Scanner Scores
Measure antioxidants in the palm of the skin.
Time frame: Day 0, Day 28, Day 56
Determine changes in skin advanced glycation endproducts (AGE) levels
AGE Reader
Time frame: Day 0, Day 28, Day 56