The Effects of a Longevity Supplement on Aging and Photoaging
Primary Purpose
Photoaging
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-aging Supplement
Placebo
Sponsored by
About this trial
This is an interventional other trial for Photoaging
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.
Sites / Locations
- Integrative Skin Science and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anti-aging Supplement
Placebo excipients
Arm Description
Mixture (powder) of vitamins and nutrients
All excipients in powder WITHOUT vitamins and nutrients
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Skin hydration
Skin hydration measured by non-invasive device
Skin elasticity
Skin viscoelasticity measured by non-invasive device
Fasting lipids
Change in fasting lipids (LDL, HDL)
Hemoglobin A1c
Change in Hemoglobin A1c
Ultra-sensitive CRP
Change in ultra-sensitive CRP
Blood pressure
Change in blood pressure (diastolic and systolic)
Mental health survey
Assessment of mental health status by survey
Subjective skin health survey
Subjective assessment of skin health by survey
Epigenetic signals
Evaluation of epigenetic expression changes
Full Information
NCT ID
NCT05262036
First Posted
February 13, 2022
Last Updated
October 18, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
AgeLess Sciences Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05262036
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
AgeLess Sciences Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-aging Supplement
Arm Type
Experimental
Arm Description
Mixture (powder) of vitamins and nutrients
Arm Title
Placebo excipients
Arm Type
Placebo Comparator
Arm Description
All excipients in powder WITHOUT vitamins and nutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
Anti-aging Supplement
Intervention Description
Mixture of different vitamins and nutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Excipient powder
Primary Outcome Measure Information:
Title
Appearance of Fine Lines and Wrinkles
Description
Fine lines and wrinkles measured by high resolution photography (BTBP Clarity Pro) to measure wrinkle severity (combines depth and width). Measured by computer calculation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Appearance of facial redness
Description
Change in the appearance of facial redness by high resolution photography (BTBP Clarity Pro) and measures intensity of facial redness. Measured by computer calculation
Time Frame
6 months
Title
Appearance of facial pigmentation
Description
Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Measured by computer calculation
Time Frame
6 months
Title
Appearance of facial texture
Description
Change in the appearance of facial texture by high resolution photography (BTBP Clarity Pro) and measures evenness of skin surface. Measured by computer calculation
Time Frame
6 months
Title
Skin hydration
Description
Skin hydration measured by non-invasive device
Time Frame
6 months
Title
Skin elasticity
Description
Skin viscoelasticity measured by non-invasive device
Time Frame
6 months
Title
Fasting lipids
Description
Change in fasting lipids (LDL, HDL)
Time Frame
6 months
Title
Hemoglobin A1c
Description
Change in Hemoglobin A1c
Time Frame
6 months
Title
Ultra-sensitive CRP
Description
Change in ultra-sensitive CRP
Time Frame
6 months
Title
Blood pressure
Description
Change in blood pressure (diastolic and systolic)
Time Frame
6 months
Title
Mental health survey
Description
Assessment of mental health status by survey
Time Frame
6 months
Title
Subjective skin health survey
Description
Subjective assessment of skin health by survey
Time Frame
6 months
Title
Epigenetic signals
Description
Evaluation of epigenetic expression changes
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
12. IPD Sharing Statement
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The Effects of a Longevity Supplement on Aging and Photoaging
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