Healthy AgingMIDINCT05829382
A Study of Biological Effects of a Polyphenol Supplement
A study testing DailyColors™ in people with Healthy Aging, run by Helse Stavanger HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- DailyColors™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 15 Mar 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Cross-over Clinical Trial of Acute Safety and Biological Effects of a Polyphenol Supplement
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.
Read the 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
- Being tested
- DailyColors™, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DailyColors™Dietary supplement
Capsule containing active ingredient administred daily by the participant during the trial period
PlaceboDietary supplement
Capsule containing placebo administered daily by the participant during the trial period
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 weeks
Secondary outcomes (4)
Blood levels of biomarkers for inflammation
Change from baseline in the blood levels of inflammatory biomarkers, such as IL-6, TNF-α 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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, double-blind, placebo controlled, cross-over clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dag Aarsland, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829382
- Sponsor's protocol ID
- MIDI
- Acronym
- MIDI
- Status last verified
- May 2024
- First submitted
- 24 Feb 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Cross-over Clinical Trial of Acute Safety and Biological Effects of a Polyphenol Supplement
- ClinicalTrials.gov ID
- NCT05829382
- Acronym / sponsor ID
- MIDI / MIDI
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo controlled, cross-over clinical trial.
| Arm | Type | Receives |
|---|---|---|
| DailyColors™ group | Active comparator | Dietary Supplement: DailyColors™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% |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboMicro 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DailyColors™Capsule containing active ingredient administred daily by the participant during the trial period | Dietary supplement | DailyColors™ group |
| PlaceboCapsule containing placebo administered daily by the participant during the trial period | Dietary supplement | Placebo group |
Primary outcome
Blood levels of CD38
Time frame: 3 weeks
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.
Blood levels of NAD+
Time frame: 3 weeks
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.
4 secondary outcomes
Blood levels of biomarkers for inflammation
Time frame: 3 weeks
Blood-based measurement of total antioxidant capacity
Time frame: 3 weeks
Blood levels of 4-HNE
Time frame: 3 weeks
Blood levels of protein carbonyl
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Aarsland, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DailyColors™ in people with Healthy Aging, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels of CD38 (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.