A Study of Biological Effects of a Polyphenol Supplement

NCT05829382 | Completed

• 1 other identifier: MIDI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Blood levels of biomarkers for inflammation

  3 weeks

• Blood-based measurement of total antioxidant capacity

  3 weeks

• Blood levels of 4-HNE

  3 weeks

• Blood levels of protein carbonyl

  3 weeks

Study Arms (2)

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%

Dietary Supplement: DailyColors™

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.

Dietary Supplement: Placebo

Interventions

DailyColors™ DIETARY_SUPPLEMENT

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

DailyColors™ group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger Universitetssjukehus

Stavanger, Norway

Location

Study Officials

• Dag Aarsland, PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo controlled, cross-over clinical trial.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: April 25, 2023
• Study Start: March 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)