A Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption

NCT06749808 | Enrolling By Invitation

• 1 other identifier: NSE-66-24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrition Status

Keywords

carotenoids; nutritional supplement; nutritional status

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 weeks

Secondary Outcomes (4)

• Skin Attribute Assessment

  8 weeks

• Product Safety

  8 weeks

• Product Safety

  8 weeks

• Product Safety

  8 weeks

Study Arms (2)

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

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

Dietary Supplement: Placebo

Interventions

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

Active

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

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Pharmanex: lead

Study Sites (1)

Nu Skin

Provo, Utah, 84601, United States

Location

Study Design

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

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 27, 2024
• Study Start: December 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)