Nutrition AssessmentNCT07380438
A Clinical Study to Evaluate the Efficacy of a Nutritional Supplement to Improve Carotenoid Content as Measured by a Non-invasive Hyperspectral Absorption Device
A study testing LifePak Optimum nutritional supplement in people with Nutrition Assessment, run by Pharmanex at 1 site in South Korea.
Trial 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?… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Assessment
- What is being tested?
- LifePak Optimum nutritional supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-60 years.
- all skin types
- BMI between 18.5-23
- No allergy with carotenoid-containing supplements
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
- Being tested
- LifePak Optimum nutritional supplement, Placebo supplement
- Keywords
- antioxidant, carotenoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifePak Optimum nutritional supplementDietary 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 supplementDietary supplement
Placebo supplement
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | LifePak Optimum nutritional supplement Receives: Dietary Supplement: LifePak Optimum nutritional supplement |
| Placebo | Placebo comparator | Placebo supplement Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Skin color measurement via Spectrophotometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Oct 2025
- Primary completion20 Nov 2025
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yonsei University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380438
- Sponsor's protocol ID
- 25-K540049EPE
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy of Nutritional Supplements on Human Health and to Assess the Reliability of Sponsor's Device
- ClinicalTrials.gov ID
- NCT07380438
- Acronym / sponsor ID
- 25-K540049EPE
- Conditions
- Nutrition Assessment
- Keywords
- antioxidant, carotenoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Yonsei University
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: LifePak Optimum nutritional supplementLifePak Optimum nutritional supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementPlacebo supplement |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 20-60 years.
- all skin types
- BMI between 18.5-23
- No allergy with carotenoid-containing supplements
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifePak Optimum nutritional supplementCa(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) | Dietary supplement | Active |
| Placebo supplementPlacebo supplement | Dietary supplement | Placebo |
Primary outcome
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.
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.
Skin color measurement via Spectrophotometer
Time frame: 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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifePak Optimum nutritional supplement in people with Nutrition Assessment, run by Pharmanex at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin carotenoid score via Prysm iO device (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.