The Effects of a Longevity Supplement on Aging and Photoaging

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Photoaging
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Anti-aging Supplement

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: AgeLess Sciences Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): August 9, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: NS-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No