The Impact of 12 Week Retention of Nutrients on Skin and the Perception of Physical Health Status
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinaNorm
About this trial
This is a randomized, double-blind, placebo-controlled clinical trial exploring the effects of a 12-week dietary supplement regimen on skin condition and perceived overall health status.
The study will involve 120 healthy Chinese adults aged 18 and above with low daily fruit and vegetable intake. Participants will be randomly assigned to one of two groups: one group will take a combination of Nu Skin's Vitamin C \& Green Tea Capsules and Multivitamin \& Mineral Capsules, while the other group will take a matching placebo.
The primary goal is to assess if the supplement combination improves skin health after 12 weeks, measured through specialized facial imaging (assessing spots, redness, evenness) and probe measurements (assessing elasticity, moisture, gloss). Secondary goals include evaluating changes in participants' self-perceived health status (via quality of life, fatigue, and digestive health questionnaires), psychological resilience, memory, and exploring a new method for measuring skin carotenoid levels.
This study is not intended to verify the approved health functions of the products but to explore the potential combined effects of antioxidant and nutritional supplementation on skin and general well-being.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Chinese adults of Asian descent aged 18 and above;
Daily fruit and vegetable intake < 240g (calculated based on the fruit and vegetable section of the food frequency questionnaire);
S3 measurement index < 30000;
Participants must possess basic Chinese reading comprehension and expression skills, and be able to independently complete questionnaire surveys;
Disqualifiers
Presence of open facial skin lesions, clearly visible scars, acne marks, etc.;
Skin lesions, scars, or significant pigmentation on the hand measurement area;
Symptoms of skin disease on the face or hand measurement areas;
Having undergone medical aesthetic procedures within the last 6 months;
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin C & Green Tea Capsules + Multivitamin & Mineral Capsules Combination
Dietary supplementParticipants take a combination of active supplements-specifically, Vitamin C \& Green Tea Capsules and Multivitamin \& Mineral Capsules-orally twice daily.
Placebo Combination (Matching)
Dietary supplementParticipants take a matching placebo combination (identical in appearance and taste to the active supplements) orally twice daily
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Supplement Combination GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Facial Image Capture VISIA-7
Time frame
Imaging sessions are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks)2
Skin Elasticity Test Probe Cutometer
Time frame
Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks)3
Skin Gloss Measurement Glossmeter
Time frame
Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).4
Skin Moisture Content Corneometer
Time frame
Measurements are conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks)Secondary outcomes
1
Skin Condition Survey
This survey assesses participants' subjective perception of their skin condition over the past month. It consists of two parts: 1) The Fitzpatrick Skin Typing Questionnaire determines the participant's skin type (I-VI) based on genetic predisposition, tanning ability, and sun reaction. 2) The Skin Status Self-Assessment uses a 100mm visual analog scale for participants to rate various aspects of their skin, including photo-damage (acute and chronic), brightness, glossiness, smoothness, hydration, pore appearance, evenness, softness, elasticity, overall wrinkles, appearance, plumpness, firmness, and spots.
Time frame
The scales and questionnaires are administered at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).2
Physical Health and Life Status Survey
This comprehensive survey evaluates participants' perceived physical health and quality of life over the past month. It incorporates five validated instruments: the SF-36 Health Survey, the Frequency of Physical Discomfort Questionnaire, the Gastrointestinal Discomfort Symptoms Questionnaire , the Population-Based Visual Fatigue Scale, and the TCM Constitution Classification and Determination Self-Assessment Table .
Time frame
The survey is administered at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).3
Psychological State and Memory Level
This component measures participants' subjective psychological state and memory function over the past month. It uses two main instruments: 1) The Brief Resilience Scale (BRS) assesses the ability to bounce back from stress and adversity (psychological resilience). 2) The Multifactorial Memory Questionnaire (MMQ) is divided into three subscales evaluating memory satisfaction/ability (Contentment), frequency of memory failures (Ability), and the use of compensatory strategies (Strategy).
Time frame
The assessment is conducted at T0 (baseline), T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks).4
Self-Evaluation Questionnaire
This questionnaire is specifically designed for participants to subjectively evaluate the effects of the product intervention. It assesses perceived improvements in areas such as energy levels, overall health status, immune function, recovery speed from illness, quality of life, and the product's contribution to long-term health using a Likert scale.
Time frame
This questionnaire is administered only at follow-up visits: T4w (4 weeks), T8w (8 weeks), and T12w (12 weeks). Source ClinicalTrials.gov