Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829382
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2023-02-24
Brief Title:
A Study of Biological Effects of a Polyphenol Supplement
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Cross-over Clinical Trial of Acute Safety and Biological Effects of a Polyphenol Supplement
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDI
Brief 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 046 at a power 90 To account for dropout the investigators will include 26 subjects in total
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 046 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 placeboDailycolors for a week in random order In addition participants will be invited to participate in an open-label extension study for 3 months
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 placeboDailycolors for a week in random order In addition participants will be invited to participate in an open-label extension study for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None