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NCT Number: NCT07380438

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

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Key information

Conditions

Nutrition Assessment

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I.E.C. Korea

Suwon, Gyeonggi-do, 16690, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Placebo supplement

Dietary Supplement

Placebo supplement

Primary outcomes

  1. 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.

  2. 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.

  3. Skin color measurement via Spectrophotometer

    Time frame: 8 weeks

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Collaborators

  • Yonsei University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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