A randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the Investigational Product "DailyColors™" (DC) on age-related pathways in adults. The aim of this study is to measure the effects of acute treatment with DC on key pathways relevant to healthy ageing using blood biomarkers. Based on power calculations a sample size of 20, is sufficient to detect an effect size of 0.46 at a power \> 90%. To account for dropout the investigators will include 26 subjects in total.
Aims: The aim of this study is to measure the effects of acute treatment with DC on key pathways relevant to healthy ageing using blood biomarkers. Hypotheses: There will be preliminary evidence that the IP has positive clinical effects on biologically relevant pathways related to healthy aging of brain and muscle including blood markers of inflammation, oxidative stress markers, and trophic factors. Design: A randomized, double-blind, placebo controlled, cross-over trial to investigate the effect of the Investigational Product (DailyColors™) on age-related pathways in adults. Participants will receive DailyColors™ or placebo for a week, then one week wash-out, and then placebo/Dailycolors™ for a week, in random order. In addition, participants will be invited to participate in an open-label extension study for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
Capsule containing active ingredient administred daily by the participant during the trial period
Capsule containing placebo administered daily by the participant during the trial period
Stavanger Universitetssjukehus
Stavanger, Norway
Blood levels of CD38
Change from baseline in the blood levels of CD38 at 1hour, 2 hours, 24 hours and week 1 and week 3. Blood CD38 is measured using commercially available immunoassays.
Time frame: 3 weeks
Blood levels of NAD+
Change from baseline in the blood levels of NAD+ at 1hour, 2 hours, 24 hours and week 1 and 3. Blood NAD+ is measured using commercially available assay kits.
Time frame: 3 weeks
Blood levels of biomarkers for inflammation
Change from baseline in the blood levels of inflammatory biomarkers, such as IL-6, TNF-α and IL-10, and IL-8 at week 1 and 3. All blood biomarkers are measured using commercially available immunoassays. All biomarkers have the same unit of measure, namely pg/mL.
Time frame: 3 weeks
Blood-based measurement of total antioxidant capacity
Change from baseline in the blood-based total antioxidant capacity at week 1 and 3, which are measured using commercially available assays.
Time frame: 3 weeks
Blood levels of 4-HNE
Change from baseline in the blood levels of 4-HNE at week 1 and week 3, which are measured using commercially available assays.
Time frame: 3 weeks
Blood levels of protein carbonyl
Change from baseline in the blood levels of protein carbonyl at week 1 and week 3, which are measured using commercially available assays.
Time frame: 3 weeks
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