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

NCT07380438 | Completed

• 1 other identifier: 25-K540049EPE
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition Assessment

Keywords

antioxidant; carotenoid

Outcome Measures

Primary Outcomes (7)

• Skin carotenoid score via Prysm iO device

  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

  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

  8 weeks

• Perceived Immunity

  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

  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

  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)

  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

Study Arms (2)

Active

ACTIVE COMPARATOR

LifePak Optimum nutritional supplement

Dietary Supplement: LifePak Optimum nutritional supplement

Placebo

PLACEBO COMPARATOR

Placebo supplement

Dietary Supplement: Placebo supplement

Interventions

Placebo supplement DIETARY_SUPPLEMENT

Placebo supplement

Placebo

LifePak Optimum nutritional supplement DIETARY_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)

Active

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanex: lead
• Yonsei University: collaborator

Study Sites (1)

I.E.C. Korea

Suwon, Gyeonggi-do, 16690, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: February 2, 2026
• Study Start: October 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: January 8, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

KR (1)