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Enrolling by Invitation

NCT Number: NCT06749808

A 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.

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nu Skin

Provo, Utah, 84601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

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Exclusion criteria

  • 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.
  • Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study supplement.
  • Concurrent therapy with any medication either topical or oral that might interfere with the study.
  • 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.
  • 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.
  • Subjects who are cigarette smokers. 11. Subjects who regularly use supplements containing >2mg carotenoids such as: LifePak, Beauty Focus Collagen+, ageLOC Youth.
  • Subjects who are unwilling or unable to comply with the requirements of the protocol.
  • Subjects who are participating in another similar research study.

Treatment and study plan

Carotenoid Nutritional Supplement

Dietary 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

Placebo

Dietary 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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Skin Attribute Assessment

    Time frame: 8 weeks

    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.

  2. Product Safety

    Time frame: 8 weeks

    Adverse event monitoring. Self-reported to primary investigator and documented.

  3. Product Safety

    Time frame: 8 weeks

    Weight (in kg) will be recorded to calculate for BMI (kg/m^2).

  4. Product Safety

    Time frame: 8 weeks

    Height: will be recorded in meters to used in BMI calculations (kg/m^2).

Sponsors and collaborators

Lead sponsor

Pharmanex

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled, Single Center Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 31, 2024

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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