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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DailyColors™ group | Active Comparator | Capsules of 150 mg of the DailyColors™ blend The investigational product is a capsule containing 150mg of the following phytonutritients: Item Name Percent of Formula Apple Extract 10.0% Pomegranate Extract 10.0% Tomato Powder 2.5% Beet - Spray Dried 2.5% Olive Extract 7.5% Rosemary Extract 7.5% Green Coffee Bean Extract (C.A) 7.5% Kale - Freeze Dried 2.5% Onion Extract 10.0% Ginger Extract 10.0% Grapefruit Extract 2.5% Carrot - Air Dried 2.5% Grape Skin Extract 17.5% Blueberry Extract 2.5% Currant - Freeze Dried 2.5% Elderberry - Freeze Dried 2.5% |
|
| Placebo group | Placebo Comparator | Micro crystalline cellulose will be used as the placebo, which will be produced with similar appearance as the active compound visually and regarding smell and taste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DailyColors™ | Dietary Supplement | Capsule containing active ingredient administred daily by the participant during the trial period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dag Aarsland, PhD | Helse Stavanger HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger Universitetssjukehus | Stavanger | Norway |
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A randomized, double-blind, placebo controlled, cross-over clinical trial.
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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 asked for consent to be contacted for participation in an open-label extension study for 3 months at a later date.
| Placebo | Dietary Supplement | Capsule containing placebo administered daily by the participant during the trial period |
|
| 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. |
| 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. | 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. | 3 weeks |