Trials / Completed
CompletedNCT05829382
A Study of Biological Effects of a Polyphenol Supplement
A Randomized, Double-blind, Placebo Controlled, Cross-over Clinical Trial of Acute Safety and Biological Effects of a Polyphenol Supplement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Helse Stavanger HF · Other Government
- Sex
- All
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | DailyColors™ | Capsule containing active ingredient administred daily by the participant during the trial period |
| DIETARY_SUPPLEMENT | Placebo | Capsule containing placebo administered daily by the participant during the trial period |
Timeline
- Start date
- 2023-03-15
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2023-04-25
- Last updated
- 2024-05-16
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT05829382. Inclusion in this directory is not an endorsement.