The Effects of a Longevity Supplement on Aging and Photoaging

NCT05262036 | Unknown

• 1 other identifier: NS-1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (12)

• Appearance of facial redness

  6 months

• Appearance of facial pigmentation

  6 months

• Appearance of facial texture

  6 months

• Skin hydration

  6 months

• Skin elasticity

  6 months

Study Arms (2)

Anti-aging Supplement

EXPERIMENTAL

Mixture (powder) of vitamins and nutrients

Dietary Supplement: Anti-aging Supplement

Placebo excipients

PLACEBO COMPARATOR

All excipients in powder WITHOUT vitamins and nutrients

Dietary Supplement: Placebo

Interventions

Anti-aging Supplement DIETARY_SUPPLEMENT

Mixture of different vitamins and nutrients

Anti-aging Supplement

Placebo DIETARY_SUPPLEMENT

Excipient powder

Placebo excipients

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• AgeLess Sciences Inc.: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Integrative Dermatologist

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: March 2, 2022
• Study Start: August 4, 2022
• Primary Completion: August 9, 2023
• Study Completion: December 31, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)