Clinical trial NCT05829382: A Study of Biological Effects of a Polyphenol Supplement
Official title: A Randomized, Double-blind, Placebo Controlled, Cross-over Clinical Trial of Acute Safety and Biological Effects of a Polyphenol Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, double-blind, placebo controlled, cross-over clinical trial.
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

* Male or female, (NB Equal number of male and female participants)
* Age between 55 and 80
* Body Mass Index (BMI) over 25 (since this group is expected to have a some degree of inflammation and other metabolic changes and more likely to respond to the supplement)
* Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
* Provided voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Alcohol or drug abuse in past year
* Subject has a known allergy to the test material's active or inactive ingredients
* Subjects with unstable, life-threatening medical conditions
* Use of polyphenol or phytochemical supplements
* Use of dietary supplements last month, except from cod liver oil or other vitamin D supplements
* Vegetarians and Vegans
* Clinically significant abnormal laboratory results at screening
* Participation in a clinical research trial within 30 days prior to randomization
* Individuals with dementia and/or who are unable to give informed consent
* Individuals with unusual high intake of fruit, berries, vegetable and/ or coffee intake, \> 5 portions of fruit, berries and/or vegetables per day or \> 5 cups of coffee per day
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.

Primary outcomes:
measure: Blood levels of CD38
timeFrame: 3 weeks
measure: Blood levels of NAD+
timeFrame: 3 weeks
Secondary outcomes:
measure: Blood levels of biomarkers for inflammation
timeFrame: 3 weeks
measure: Blood-based measurement of total antioxidant capacity
timeFrame: 3 weeks
measure: Blood levels of 4-HNE
timeFrame: 3 weeks
measure: Blood levels of protein carbonyl
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger Universitetssjukehus
Study officials:
affiliation: Helse Stavanger HF
name: Dag Aarsland, PhD
role: PRINCIPAL_INVESTIGATOR
References: