A Study of Biological Effects of a Polyphenol Supplement

NCT ID: NCT05829382

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-06-30

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.

Conditions

Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

DailyColors™ group

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%

Group Type: ACTIVE_COMPARATOR

DailyColors™

Intervention Type: DIETARY_SUPPLEMENT

Capsule containing active ingredient administred daily by the participant during the trial period

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Capsule containing placebo administered daily by the participant during the trial period

Interventions

DailyColors™

Capsule containing active ingredient administred daily by the participant during the trial period

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Capsule containing placebo administered daily by the participant during the trial period

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dag Aarsland, PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

Stavanger Universitetssjukehus

Stavanger, , Norway

Countries

Norway

Other Identifiers

MIDI

Identifier Type: -

Identifier Source: org_study_id