A Study of Biological Effects of a Polyphenol Supplement

Healthy Aging Clinical Trial

— MIDI  

Official title:

A Randomized, Double-blind, Placebo Controlled, Cross-over Clinical Trial of Acute Safety and Biological Effects of a Polyphenol Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05829382
• Other study ID #: MIDI
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Dietary Supplement:
• DailyColors™
Capsule containing active ingredient administred daily by the participant during the trial period
• Placebo
Capsule containing placebo administered daily by the participant during the trial period

Locations

Country	Name	City	State
Norway	Stavanger Universitetssjukehus	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood levels of biomarkers for inflammation	Change from baseline in the blood levels of inflammatory biomarkers, such as IL-6, TNF-a and IL-10, and IL-8 at week 1 and 3. All blood biomarkers are measured using commercially available immunoassays. All biomarkers have the same unit of measure, namely pg/mL.	3 weeks
Secondary	Blood-based measurement of total antioxidant capacity	Change from baseline in the blood-based total antioxidant capacity at week 1 and 3, which are measured using commercially available assays.	3 weeks
Secondary	Blood levels of 4-HNE	Change from baseline in the blood levels of 4-HNE at week 1 and week 3, which are measured using commercially available assays.	3 weeks
Secondary	Blood levels of protein carbonyl	Change from baseline in the blood levels of protein carbonyl at week 1 and week 3, which are measured using commercially available assays.	3 weeks