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| Name | Class |
|---|---|
| Yonsei University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | LifePak Optimum nutritional supplement |
|
| Placebo | Placebo Comparator | Placebo supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifePak Optimum nutritional supplement | Dietary Supplement | Ca(mg) Vit C(mg) Mg(mg) Se(㎍) Cr(㎍) Vit E(mg a-TE) Mo(㎍) Pantothenic acid(mg) Vit B12(㎍) Niacin(mgNE) Zn(mg) Vit B6(mg) Biotin(㎍) Vit D(㎍) Vit B1(mg) Vit B2(mg) Cu(mg) Mn(mg) Vit K(㎍) Folic acid(㎍)_Folic acid Iodine(㎍) Beta-carotene(mg) Lycopene(mg) Lutein(mg) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 8 weeks |
| Skin color measurement via Spectrophotometer | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.E.C. Korea | Suwon | Gyeonggi-do | 16690 | South Korea |
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| Placebo supplement | Dietary Supplement | Placebo supplement |
|
| 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. | 8 weeks |