- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513597
Assessment of the Effects of a Daily Supplement 4Life Transfer Factor Vista Containing AREDS2 Formula on Skin Carotenoid Levels Using a Non-invasive Detection
March 31, 2026 updated by: 4Life Research, LLC
Assessment of the Effects of a Daily Supplement 4Life Transfer Factor Vista Containing the AREDS2 Formula on Skin Carotenoid Levels Using a Non-Invasive Method
The goal of the clinical study is to evaluate the impact of daily use of a dietary supplement TF Vista containing AREDS2 formula ingredients, astaxanthin (Haematococcus pluvialis) microalgae, bilberry (Vaccinium myrtillus) fruit powder and black currant (Ribes nigrum) fruit powder organic on skin carotenoid levels over an 8-week period for a Cohort 1(n= 20 participants) and 12 weeks for a Cohort 2 (n= 4 participants).
Results will be compared using two devices - the Veggie Meter and the Samsung Watch - both of which utilize reflection spectroscopy technology.
For Cohort 2 (n = 4 participants), in addition to assessing skin carotenoid levels, the study will also evaluate changes in macular pigment optical density (MPOD) before and after supplementation.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Sandy City, Utah, United States, 84070
- 4Life Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy subjects ≥ 18 years of age. Committed to maintain the same eating, exercise, and other lifestyle routines for the whole duration of the study.
Exclusion Criteria:
- • Pregnant and/or lactating women or planning to become pregnant in the following 12 weeks.
- Participants were not allowed to participate if they have a known allergy or adverse reaction to any of the ingredients in the study product.
- Participants were not allowed to participate if they have used AREDS2 formula products over the past 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 4lLife TF Vista
Participants were supplied with two bottles of the study product (for Cohort-1) and three bottles (for Cohort-2) labeled with the participant number during the study.
They were required to take the product consisting of 4 capsules per day, taken with 8 oz. of fluid and preferably with a meal.
|
Study product 4Life TF Vista contains Tri Factor (bovine colostrum and egg yolk), bilberry (Vaccinium myrtillus) fruit powder, black currant (Ribes Nigrum) powder, lutein, zeaxanthin (Tagetes erecta), vitamin C, vitamin A, vitamin E, zinc, and copper.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin Carotenoid Levels
Time Frame: From enrollment to the end of treatment at 8 weeks for Cohort-1 and 12 weeks for Cohort-2
|
Skin carotenoid levels measured via a portable Veggie Meter, Longevity Link Corp. device using reflection spectroscopy on a participant's fingerprint.
|
From enrollment to the end of treatment at 8 weeks for Cohort-1 and 12 weeks for Cohort-2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Antioxidant Levels
Time Frame: From enrollment to the end of treatment at 8 weeks for Cohort-1 and 12 weeks for Cohort-2.
|
Antioxidant levels assessed by a Samsung Watch device via skin absorption spectra.
The bioactive sensor measures reflected light after emitting LED light.
The test requires the participant to press the thumb on the sensor for a few seconds to get a reading.
|
From enrollment to the end of treatment at 8 weeks for Cohort-1 and 12 weeks for Cohort-2.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Macular Pigment Optical Density (MPOD)
Time Frame: At enrollment and at the end of the treatment (week-12)
|
Macular Pigment Optical Density (MPOD) testing measurement of the density of the light-absorbing pigments in the center of the retina.
This tests is performed only for participants in Cohort-2.
|
At enrollment and at the end of the treatment (week-12)
|
|
Visual Acuity Test
Time Frame: From enrollment to the end of treatment at 8 weeks.
|
Visual Acuity Test to measure sharpest vision using a Snellen eye chart, to determine the smallest detail a participant can see from 20 feet distance.
Test will be performed only for participants included in Cohort-1
|
From enrollment to the end of treatment at 8 weeks.
|
|
Amsler Grid Chart Test
Time Frame: From enrollment to the end of treatment at 8 weeks.
|
Amsler Grid Chart Test to monitor central vision for changes like way, blurry, or missing lines.
Test performed only on participants included in Cohort-1.
|
From enrollment to the end of treatment at 8 weeks.
|
|
Visual Functioning Questionnaire-25 (VFQ-25)
Time Frame: From enrollment to the end of treatment at 8 weeks.
|
Visual Functioning Questionnaire-25 (VFQ-25) to assess participants self-reported vision- related quality of life.
For participants included in Cohort-1.
|
From enrollment to the end of treatment at 8 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Vollmer, 4Life Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2025
Primary Completion (Actual)
December 17, 2025
Study Completion (Actual)
February 14, 2026
Study Registration Dates
First Submitted
March 31, 2026
First Submitted That Met QC Criteria
March 31, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4LIFE2026-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Carotenoids
-
Stanford UniversityRecruitingNo Condition | Skin Carotenoids and Immune-agingUnited States
-
USDA, Western Human Nutrition Research CenterCompletedBioavailability of CarotenoidsUnited States
-
National University, SingaporeClinical Nutrition Research Centre, SingaporeCompletedCarotenoidsSingapore
-
Purdue UniversityCompletedAbsorption of Carotenoids From VegetablesUnited States
-
Institut National de la Recherche AgronomiqueAix Marseille Université; Hôpital de la ConceptionCompletedDigestion Chambers | Stability and Metabolism of Carotenoids and Vitamin EFrance
-
Instituto de Ciencia y Tecnología de Alimentos...Instituto de Salud Carlos III; Puerta de Hierro University Hospital; Comunidad...CompletedBiological Availability | Carotenoids | Humans | LuteinSpain
-
Penn State UniversityOrlando Regional Medical Center; MacuHealthCompleted
-
AB Biotics, SAKaneka Americas Holding Inc.; HellobiomeNot yet recruitingSkin | Skin Microbiome | Skin Microbiota | Skin Ageing
Clinical Trials on Dietary Supplement
-
Bionos Biotech S.L.CompletedSkin Hydration in Healthy Volunteers | Skin Ageing | Facial Wrinkles - Rough Texture - HyperpigmentationSpain
-
Biosearch S.A.Universidad de Granada; University Hospital Virgen de las NievesTerminatedKnee DiscomfortSpain
-
University of Novi Sad, Faculty of Sport and Physical...Completed
-
Fonterra Research CentreCompleted
-
Universidade Federal do AmazonasCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Hospital Universitario... and other collaboratorsCompletedOverweight | HypercholesterolemiaBrazil
-
Larissa University HospitalRecruitingDumping Syndrome | Gastric SurgeryGreece
-
Texas Tech UniversityEHP LabsCompletedBody Weight Changes | Body Composition Changes | Anthropometric Changes | Metabolism Changes | Hemodynamic ChangesUnited States
-
University Hospital OstravaRecruitingCritical Illness | Prolonged Mechanical VentilationCzechia
-
Ultra Botanica LLCActive, not recruitingJoint Discomfort | Quality of Life (QOL)United States
-
NeuroEnergy Ventures, Inc.Active, not recruiting