Nutrition StatusNCT06749808
A Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
A study testing Carotenoid Nutritional Supplement in people with Nutrition Status, run by Pharmanex at 1 site in United States.
Trial summary
The objective of this placebo controlled randomized research is to demonstrate the health benefits of a carotenoid nutritional supplement as compared to placebo in terms of nutrient levels, quality of life, feelings, of wellness, brain health, energy, immunity, and appearance. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Status
- What is being tested?
- Carotenoid Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects male or female age 20-65 years old.
- Subjects who score 30,000 or below on the Pharmanex BioPhotonic Scanner.
- Subjects of Fitzpatrick skin types I-VI with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be able to read, understand and provide written informed consent.
- Individuals must agree to continue to use all regular brands of cosmetics and the assigned test materials for the duration of the study. Individuals must refrain from using any new products other than the assigned test supplements.
- Subjects must agree to avoid excessive sun exposure (no more than 10-15 minutes of direct sunlight without SPF protection) and the use of artificial tanning methods for the duration of the study.
- -
Who cannot join
- 1. Individuals who are participating in any other research study. 2. Subjects who are regularly taking oral nutritional supplements containing carotenoids as specified by the sponsor.
- 3. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study supplement.
- 4. Concurrent therapy with any medication either topical or oral that might interfere with the study.
- 5. Subjects who are alcohol or narcotic addicts. 6. Subjects who are unwilling to leave their current oral medications unchanged for the duration of the study.
- 7. Subjects who use an indoor tanning booth. 8. Subjects, who are pregnant, breast feeding or planning a pregnancy. 9. Subjects with clinically significant unstable medical disorders, such as cancer, diabetes, neurodegenerative disorders, active autoimmune disease, liver or kidney disease, schizophrenia, depression, other major mental illness.
- 10. Subjects who are cigarette smokers. 11. Subjects who regularly use supplements containing >2mg carotenoids such as: LifePak, Beauty Focus Collagen+, ageLOC Youth.
- 12. Subjects who are unwilling or unable to comply with the requirements of the protocol.
- 13. Subjects who are participating in another similar research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Single Center Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
The objective of this placebo controlled randomized research is to demonstrate the health benefits of a carotenoid nutritional supplement as compared to placebo in terms of nutrient levels, quality of life, feelings, of wellness, brain health, energy, immunity, and appearance.
Read the detailed description
Female or male subjects will be enrolled in this single site study to evaluate the efficacy and tolerability of a nutritional supplement. Subjects who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled at the baseline visit. Vital signs will be obtained (height, weight, blood pressure, heart rate). Subjects must meet the study BMI requirements (≥18.5 and ≤29.9 kg/m2 ). Subjects will also complete BioPhotonic Scanner screening. If subjects meet all requirements, they will be randomized to receive either the active nutritional supplement or a placebo. Subjects will undergo phlebotomy for baseline lab work consisting of carotenoid analysis. Subjects will complete the following questionnaires/measurements:
- Quality of Life Questionnaire
- Diet and Lifestyle Questionnaire
- Subject Skin Assessment
- Biophotonic Scanner measurement
- Mini-4 Scanner measurement
The nutritional supplement will be started and the subjects will return to the research center at Weeks 4 and 8 for evaluation.
- Conditions
- Nutrition Status
- Being tested
- Carotenoid Nutritional Supplement, Placebo
- Keywords
- carotenoids, nutritional supplement, nutritional status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoid Nutritional SupplementDietary supplement
Carotenoid Nutritional Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 10 mg Lutein, 2 mg Zeaxanthin, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc
PlaceboDietary supplement
Placebo Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Carotenoid Nutritional Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 10 mg Lutein, 2 mg Zeaxanthin, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc Receives: Dietary Supplement: Carotenoid Nutritional Supplement |
| Placebo | Placebo comparator | Placebo Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient analysis
Nutrient levels as measured by blood serum carotenoids and correlated to BioPhotonic Scanner and Mini-4 scanner assessment. Higher blood serum carotenoid levels and scan scores indicate greater improvement.
Measured: 8 weeks
Wellness Assessment
Subject self-assessment of global wellness via questionnaire. Likert Scale: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree. Higher score indicates greater satisfaction/improvement.
Measured: 8 weeks
Secondary outcomes (4)
Skin Attribute Assessment
Assessment of facial skin improvements evaluated by self-perception questionnaire. Likert Scale: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree. Higher scores indicate greater satisfaction/improvement.
Measured: 8 weeks
Product Safety
Adverse event monitoring. Self-reported to primary investigator and documented.
Measured: 8 weeks
Product Safety
Weight (in kg) will be recorded to calculate for BMI (kg/m^2).
Measured: 8 weeks
Product Safety
Height: will be recorded in meters to used in BMI calculations (kg/m^2).
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 posted27 Dec 2024
- Study start1 Dec 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition StatusStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749808
- Sponsor's protocol ID
- NSE-66-24
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Single Center Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
- ClinicalTrials.gov ID
- NCT06749808
- Acronym / sponsor ID
- NSE-66-24
- Conditions
- Nutrition Status
- Keywords
- carotenoids, nutritional supplement, nutritional status
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Dec 2024 (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 objective of this placebo controlled randomized research is to demonstrate the health benefits of a carotenoid nutritional supplement as compared to placebo in terms of nutrient levels, quality of life, feelings, of wellness, brain health, energy, immunity, and appearance.
Detailed description
Female or male subjects will be enrolled in this single site study to evaluate the efficacy and tolerability of a nutritional supplement. Subjects who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled at the baseline visit. Vital signs will be obtained (height, weight, blood pressure, heart rate). Subjects must meet the study BMI requirements (≥18.5 and ≤29.9 kg/m2 ). Subjects will also complete BioPhotonic Scanner screening. If subjects meet all requirements, they will be randomized to receive either the active nutritional supplement or a placebo. Subjects will undergo phlebotomy for baseline lab work consisting of carotenoid analysis. Subjects will complete the following questionnaires/measurements:
- Quality of Life Questionnaire
- Diet and Lifestyle Questionnaire
- Subject Skin Assessment
- Biophotonic Scanner measurement
- Mini-4 Scanner measurement
The nutritional supplement will be started and the subjects will return to the research center at Weeks 4 and 8 for evaluation.
Study design
- Primary purpose
- Basic science
- 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: Carotenoid Nutritional SupplementCarotenoid Nutritional Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 10 mg Lutein, 2 mg Zeaxanthin, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects male or female age 20-65 years old.
- Subjects who score 30,000 or below on the Pharmanex BioPhotonic Scanner.
- Subjects of Fitzpatrick skin types I-VI with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be able to read, understand and provide written informed consent.
- Individuals must agree to continue to use all regular brands of cosmetics and the assigned test materials for the duration of the study. Individuals must refrain from using any new products other than the assigned test supplements.
Key exclusion criteria (8 listed)
- 1. Individuals who are participating in any other research study. 2. Subjects who are regularly taking oral nutritional supplements containing carotenoids as specified by the sponsor.
- 3. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study supplement.
- 4. Concurrent therapy with any medication either topical or oral that might interfere with the study.
- 5. Subjects who are alcohol or narcotic addicts. 6. Subjects who are unwilling to leave their current oral medications unchanged for the duration of the study.
- 7. Subjects who use an indoor tanning booth. 8. Subjects, who are pregnant, breast feeding or planning a pregnancy. 9. Subjects with clinically significant unstable medical disorders, such as cancer, diabetes, neurodegenerative disorders, active autoimmune disease, liver or kidney disease, schizophrenia, depression, other major mental illness.
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 |
|---|---|---|
| Carotenoid Nutritional SupplementCarotenoid Nutritional Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 10 mg Lutein, 2 mg Zeaxanthin, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc | Dietary supplement | Active |
| PlaceboPlacebo Supplement: capsules with 500 mg Vitamin C, 200 IU Vitamin E, 25 mg Zinc, 2 mg Copper, 70 mcg Selenium, 3mg boron, 255mg calcium, 100mcg chromium, 0.9mg copper, 150mcg iodide, 180mg magnesium, 75mcg molybdenum, 2.3mg manganese, 140mcg selenium, 20mcg vanadium, 15mg zinc | Dietary supplement | Placebo |
Primary outcome
Nutrient analysis
Time frame: 8 weeks
Nutrient levels as measured by blood serum carotenoids and correlated to BioPhotonic Scanner and Mini-4 scanner assessment. Higher blood serum carotenoid levels and scan scores indicate greater improvement.
Wellness Assessment
Time frame: 8 weeks
Subject self-assessment of global wellness via questionnaire. Likert Scale: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree. Higher score indicates greater satisfaction/improvement.
4 secondary outcomes
Skin Attribute Assessment
Time frame: 8 weeks
Product Safety
Time frame: 8 weeks
Product Safety
Time frame: 8 weeks
Product Safety
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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 Carotenoid Nutritional Supplement in people with Nutrition Status, run by Pharmanex at 1 site in United States.
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 7 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: enrolling by invitation, as of the sponsor's last update on 31 Dec 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Nutrient analysis (time frame: 8 weeks). The study lists 2 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 31 Dec 2024.