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PhotoagingNCT05262036

The Effects of a Longevity Supplement on Aging and Photoaging

A study testing Anti-aging Supplement in people with Photoaging, run by Integrative Skin Science and Research at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the use of an oral supplement to see if it can shift the function of the skin and the appearance of fine lines and wrinkles, its impact on biomarkers associated with aging, and its impact on mental health. Read more about this study

Who is it for?
Ages 35 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Photoaging
What is being tested?
Anti-aging Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
4 Aug 2022to 31 Dec 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 35 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female and male subjects
  • Subjects who are between the ages of 35 to 70.
  • Subjects must be able to read and comprehend study procedure and consent forms
  • Must be willing to comply with all protocol requirements
  • Must be willing to have facial photographic images taken

Who cannot join

  • Women who have been pregnant in the last three months, currently pregnant, preparing to become pregnant during the study, or breastfeeding.
  • Individuals who have a history of smoking or chewing tobacco or vaping nicotine based product within the past year or if the pack-year history of smoking tobacco is greater than 5 pack-years.
  • Those that have undergone a change in hormone-based therapies such as, but not limited to, oral contraceptive pills or progesterone pills within the last 2 months. Progesterone releasing IUDs are considered hormone-based therapy. Spironolactone is not considered a hormone-based therapy.
  • Subjects who are unwilling or unable to comply with the requirements of the protocol.
  • Subjects who have a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study in the opinion of the principal investigator.
  • Has a skin disease on the face that will interfere with image collection and assessment in the opinion of the investigator.
Show all 19Show fewer
  • History of any significant chronic disease including endocrine, inflammatory, cardiovascular, renal, liver, gastro-intestinal, psychiatric, neurological, neoplastic, or metabolic disease for at least 90 days prior to screening. Clinical significance of active disease will be assessed by the Qualified Investigator to determine eligibility.
  • Subjects with or who have recently experienced traumatic injury, infections, or major surgery at the discretion of the Qualified Investigator.
  • Subjects who are likely to start taking drugs/medication on a chronic basis or that will undergo surgery during the trial.
  • Subjects engaged in donation or who were recipients of blood products within 90 days before the start of the study.
  • Subjects with alcohol use of more than 2 alcoholic beverages per day within the past month.
  • Subjects participated in a clinical trial with a medicinal, supplemental, nutraceutical or drug within the past two months prior to the first dose in the current study.
  • Use of lipid, cholesterol and/or blood-sugar lowering agents (e.g. statins, fibrates, bile acid sequestrants, PCSK9 inhibitors, prescription-based nicotinic acid derivatives (e.g. niacin extended release), metformin, sulfonylureas, including fish oil). If participants take fish oil supplements, they will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
  • Subjects using anti-inflammatory drugs on a chronic basis (e.g. aspirin, ibuprofen, diclofenac, celecoxib, etc).
  • Subjects using supplements or substances present in formulation (malate, fisetin, glucosamine, alpha ketoglutaric acid, glycine, theanine, Rhodiola rosea, hyaluronic acid, ginger extract, pterostilbene, lithium). Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
  • Subjects using supplements or substances similar as those used in the formulation (e.g. resveratrol (similar to pterostilbene) or quercetin (similar to fisetin)). Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
  • Subjects taking NAD boosters, like NMN, nicotinamide riboside (NR), high-dose niacin (nicotinic acid), high-dose vitamin B3, high-dose nicotinamide (niacinamide) within 21 days before the start of the trial. Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
  • Subjects taking supplements or drugs or nutraceuticals to improve skin, such as hyaluronic acid, collagen, chondroitin, glucosamine. Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
  • Subjects with clinically significant abnormal laboratory results at screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Integrative Skin Science and Research

    Sacramento, California, 95815

Other trials in United States

About this study

Official title: The Effects of a Longevity Supplement on Skin Health, Blood Biomarkers and Mental Health

This study evaluates the use of an oral supplement to see if it can shift the function of the skin and the appearance of fine lines and wrinkles, its impact on biomarkers associated with aging, and its impact on mental health.

Conditions
Photoaging
Being tested
Anti-aging Supplement, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-aging SupplementDietary supplement

    Mixture of different vitamins and nutrients

  • PlaceboDietary supplement

    Excipient powder

Study groups in NCT05262036
Study groupRoleWhat they receive
Anti-aging SupplementExperimentalMixture (powder) of vitamins and nutrients
Receives: Dietary Supplement: Anti-aging Supplement
Placebo excipientsPlacebo comparatorAll excipients in powder WITHOUT vitamins and nutrients
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appearance of Fine Lines and Wrinkles

    Fine lines and wrinkles measured by high resolution photography (BTBP Clarity Pro) to measure wrinkle severity (combines depth and width). Measured by computer calculation.

    Measured: 6 months

Secondary outcomes (12)

  1. Appearance of facial redness

    Change in the appearance of facial redness by high resolution photography (BTBP Clarity Pro) and measures intensity of facial redness. Measured by computer calculation

    Measured: 6 months

  2. Appearance of facial pigmentation

    Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Measured by computer calculation

    Measured: 6 months

  3. Appearance of facial texture

    Change in the appearance of facial texture by high resolution photography (BTBP Clarity Pro) and measures evenness of skin surface. Measured by computer calculation

    Measured: 6 months

  4. Skin hydration

    Skin hydration measured by non-invasive device

    Measured: 6 months

  5. Skin elasticity

    Skin viscoelasticity measured by non-invasive device

    Measured: 6 months

  6. Fasting lipids

    Change in fasting lipids (LDL, HDL)

    Measured: 6 months

  7. Hemoglobin A1c

    Change in Hemoglobin A1c

    Measured: 6 months

  8. Ultra-sensitive CRP

    Change in ultra-sensitive CRP

    Measured: 6 months

  9. Blood pressure

    Change in blood pressure (diastolic and systolic)

    Measured: 6 months

  10. Mental health survey

    Assessment of mental health status by survey

    Measured: 6 months

  11. Subjective skin health survey

    Subjective assessment of skin health by survey

    Measured: 6 months

  12. Epigenetic signals

    Evaluation of epigenetic expression changes

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start4 Aug 2022
  3. Primary completion9 Aug 2023
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262036
Sponsor's protocol ID
NS-1
Status last verified
Oct 2023
First submitted
13 Feb 2022
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Anti-aging Supplement in people with Photoaging, run by Integrative Skin Science and Research at 1 site in United States.

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 19 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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 United States. 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?

Results are not available in the source record.

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?

Appearance of Fine Lines and Wrinkles (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262036.

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 23 Oct 2023.

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