A Clinical Study to Evaluate the Efficacy of a Nutritional Supplement to Improve Carotenoid Content as Measured by a Non-invasive Hyperspectral Absorption Device

January 28, 2026 updated by: Pharmanex

A Clinical Study to Evaluate the Efficacy of Nutritional Supplements on Human Health and to Assess the Reliability of Sponsor's Device

The goal of this clinical trial is to evaluate a nutritional supplement in an otherwise healthy adult population. The main questions it aims to answer are:

  • Do antioxidant carotenoid levels increase in after supplementation as measured by a non-invasive device?
  • Do wellness factors correlate with supplementation?

Researchers will compare the nutritional supplement arm to a placebo group to assess its effects.

Participants will take either the nutritional supplement or placebo once daily for 8 weeks. Participants will be scanned by a non-invasive hyperspectral absorption device to obtain a skin carotenoid score. Participants will also have facial images taken, dermal spectrophotometry measurements of their face, and complete self-assessment questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

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

  • South Korea
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16690
        • I.E.C. Korea

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 20-60 years.
  • all skin types
  • BMI between 18.5-23
  • No allergy with carotenoid-containing supplements

Exclusion Criteria:

  • subject who have undergone organ excision, organ transplantation, or experienced a skull concussion with extended loss of consciousness in the past 5 years, or with current after effects.
  • subjects with diseases such as heart disease, myocardial infarction, cancer, tuberculosis, chronic or acute renal failure, poliomyelitis, arthritis, or asthma
  • Subjects undergoing or schedule for long-term treatment, particularly with anti-inflammatory agents, steroids, sedatives, diabetes treatments, medications for blood pressure, hormone therapies, antihistamines, and/or drugs with similar functions,
  • subjects who have taken contraceptives or herbal medicines continuously for more than 2 months within the past 3 weeks,
  • subjects with any current medical condition, including gynecological disorders, or those undergoing hospital treatment,
  • subjects with known allergies to aspirin, antibiotics, fruits, laboratory substances, sunlight or metals;
  • Subjects who experience herpes outbreaks more than five times a year or suffer from acute swelling of the skin or mucous membranes;
  • Subjects with a history of psychiatric disorders, including sleep disorders or panic disorder

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo supplement
Dietary supplement: Placebo supplement
Placebo supplement
Active Comparator: Active
LifePak Optimum nutritional supplement
Dietary supplement: LifePak Optimum nutritional supplement
Ca(mg) Vit C(mg) Mg(mg) Se(㎍) Cr(㎍) Vit E(mg a-TE) Mo(㎍) Pantothenic acid(mg) Vit B12(㎍) Niacin(mgNE) Zn(mg) Vit B6(mg) Biotin(㎍) Vit D(㎍) Vit B1(mg) Vit B2(mg) Cu(mg) Mn(mg) Vit K(㎍) Folic acid(㎍)_Folic acid Iodine(㎍) Beta-carotene(mg) Lycopene(mg) Lutein(mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin carotenoid score via Prysm iO device
Time Frame: 8 weeks
The Prysm iO device will provide a numerical score between 0-1000. The score is an indicator of skin carotenoid concentration/nutritional wellness. The higher the score the more positive the outcome.
8 weeks
Short-Form 36 Health Survey
Time Frame: 8 weeks
The Short-Form 36 Health Survey is a validated questionnaire that measures multidimensional health-related quality of life, including specific domains of everyday life. The questionnaire has a 1-5 scale, with the higher score reflected a better perception of health-related outcomes.
8 weeks
Skin color measurement via Spectrophotometer
Time Frame: 8 weeks
8 weeks
Perceived Immunity
Time Frame: 8 weeks
Perceived Immunity Scale, a validated questionnaire to assess individuals' beliefs about the strength of their immune system. The assessment uses a 1-6 point Likert scale, where a lower score indicates greater disagreement with the statement, and a higher score indicates greater agreement with the statement.
8 weeks
Psychological Scales Related to Physical Condition
Time Frame: 8 weeks
Short Health Anxiety Inventory (SHAI) a validated questionnaires using a 1-5 point Likert scale, (where a lower score indicates greater disagreement, and higher score indicates greater agreement) to assess feelings about health and recovery.
8 weeks
Fatigue and Vitality Status Assessment
Time Frame: 8 weeks
Multi-Dimensional Fatigue Inventory--a validated questionnaire using a 1-7 Likert scale (where a lower score indicates greater disagreement, and a higher score indicates greater agreement) to assess an individual's fatigue state.
8 weeks
Brief Resilience Scale (BRS)
Time Frame: 8 weeks
The Brief Resilience Scale (BRS) is a validated questionnaire, using a 1-5 point Likert scale (where a lower score indicates greater disagreement, and a higher score indicates greater agreement), to assess the ability to bounce back from feelings of stress.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmanex

Collaborators

Yonsei University

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 20, 2025

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

January 8, 2026

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-K540049EPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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