The Effects of a Longevity Supplement on Aging and Photoaging

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05262036
• Other study ID #: NS-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 31, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Photoaging
• Skin Diseases

Intervention

Dietary Supplement:
• Anti-aging Supplement
Mixture of different vitamins and nutrients
• Placebo
Excipient powder

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	AgeLess Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

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