A Clinical Study to Evaluate the Efficacy of a Nutritional Supplement to Improve Carotenoid Content as Measured by a Non-invasive Hyperspectral Absorption Device

Pharmanex84 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nutrition Assessment

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 20-60 years. * all skin types * BMI between 18.5-23 * No allergy with carotenoid-containing supplements Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 8 weeks

Skin color measurement via Spectrophotometer

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks

A Clinical Study to Evaluate the Efficacy of a Nutritional Supplement to Improve Carotenoid Content as Measured by a Non-invasive Hyperspectral Absorption Device

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes