Clinical trial NCT06749808: A Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
Official title: A Randomized, Double-Blind, Placebo Controlled, Single Center Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nutrition Status
Keywords: carotenoids
nutritional supplement
nutritional status
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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:

1. Quality of Life Questionnaire
2. Diet and Lifestyle Questionnaire
3. Subject Skin Assessment
4. Biophotonic Scanner measurement
5. 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects male or female age 20-65 years old.
2. Subjects who score 30,000 or below on the Pharmanex BioPhotonic Scanner.
3. Subjects of Fitzpatrick skin types I-VI with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
4. Subjects must be able to read, understand and provide written informed consent.
5. 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.
6. 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.

  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.

Primary outcomes:
measure: Nutrient analysis
timeFrame: 8 weeks
measure: Wellness Assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Skin Attribute Assessment
timeFrame: 8 weeks
measure: Product Safety
timeFrame: 8 weeks
measure: Product Safety
timeFrame: 8 weeks
measure: Product Safety
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Provo
country: United States
facility: Nu Skin
state: Utah
Study officials:
References: