The Effects of a Longevity Supplement on Aging and Photoaging

Study Overview
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Brief Summary
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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.

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

Conditions
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Photoaging

Intervention / Treatment
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* Dietary Supplement: Anti-aging Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-aging Supplement<br>Mixture (powder) of vitamins and nutrients | Dietary Supplement: Anti-aging Supplement<br>* Mixture of different vitamins and nutrients<br>|
| Placebo Comparator: Placebo excipients<br>All excipients in powder WITHOUT vitamins and nutrients | Dietary Supplement: Placebo<br>* Excipient powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| 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 | 6 months | 
| 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 | 6 months | 
| Skin hydration | Skin hydration measured by non-invasive device | 6 months | 
| Skin elasticity | Skin viscoelasticity measured by non-invasive device | 6 months | 
| Fasting lipids | Change in fasting lipids (LDL, HDL) | 6 months | 
| Hemoglobin A1c | Change in Hemoglobin A1c | 6 months | 
| Ultra-sensitive CRP | Change in ultra-sensitive CRP | 6 months | 
| Blood pressure | Change in blood pressure (diastolic and systolic) | 6 months | 
| Mental health survey | Assessment of mental health status by survey | 6 months | 
| Subjective skin health survey | Subjective assessment of skin health by survey | 6 months | 
| Epigenetic signals | Evaluation of epigenetic expression changes | 6 months |