Clinical trial NCT05262036: The Effects of a Longevity Supplement on Aging and Photoaging
Official title: The Effects of a Longevity Supplement on Skin Health, Blood Biomarkers and Mental Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Photoaging
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: AgeLess Sciences Inc.
First posted: 2022-03-02
Enrollment: 38
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Appearance of Fine Lines and Wrinkles
timeFrame: 6 months
Secondary outcomes:
measure: Appearance of facial redness
timeFrame: 6 months
measure: Appearance of facial pigmentation
timeFrame: 6 months
measure: Appearance of facial texture
timeFrame: 6 months
measure: Skin hydration
timeFrame: 6 months
measure: Skin elasticity
timeFrame: 6 months
measure: Fasting lipids
timeFrame: 6 months
measure: Hemoglobin A1c
timeFrame: 6 months
measure: Ultra-sensitive CRP
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Mental health survey
timeFrame: 6 months
measure: Subjective skin health survey
timeFrame: 6 months
measure: Epigenetic signals
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: