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The objective of this study is to evaluate the effect of liquid vitamin C and glutathione supplements on human skin condition improvement and anti-oxidation.
This study is a single-center, placebo-controlled, double-blinded, parallel human trial designed to evaluate the skin beauty and anti-oxidant effect of liquid vitamin C and glutathione supplements.
Healthy adult participants aged 18-65 years will be enrolled. Participants will be informed to consume test samples daily for 12 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after 4, 8 weeks, and 12 weeks of consumption. Fasting blood samples will be collected at baseline and after 12 weeks of consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo sachet | Placebo Comparator |
| |
| Vitamin C and Glutathione Liquid Sachet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo sachet | Dietary Supplement | consume 1 sachet of the test samples daily for 12 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of skin tone | Chroma Meter MM500 was utilized to measure face skin tone. Units: Individual Typology Angle (ITA°) | Change from Baseline skin tone at 12 weeks |
| The change of visible spots | VISIA Complexion Analysis was utilized to measure visible spots on face. Units: the amount of detectable visible spots | Change from Baseline visible spots at 12 weeks |
| The change of UV spots | VISIA Complexion Analysis was utilized to measure UV spots on face. Units: the amount of detectable UV spots | Change from Baseline UV spots at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of skin hydration | Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120. | Change from Baseline skin hydration at 12 weeks |
| The change of skin redness |
| Measure | Description | Time Frame |
|---|---|---|
| The change of self-assessment skin condition | Skin condition was evaluated using a 5-point Likert scale (0-4) to assess the severity of skin-related symptoms. The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. | Change from Baseline skin condition at 12 weeks |
| The change of self-assessment fatigue level |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chia-Hua Liang, Ph.D. | Contact | +886-06-2664911 | 2441 | tinna_ling@mail.cnu.edu.tw |
| Ping Lin | Contact | +886-02-87977811 | candice.lin@tci-bio.com |
| Name | Affiliation | Role |
|---|---|---|
| Chia-Hua Liang, Ph.D. | Chia Nan University of Pharmacy ＆ Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chia Nan University of Pharmacy & Science | Recruiting | Pingtung City | 928 | Taiwan |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Vitamin C and Glutathione Liquid Sachet | Dietary Supplement | consume 1 sachet of the test samples daily for 12 consecutive weeks |
|
|
Chroma Meter MM500 was utilized to measure face skin redness. Units: a* value
| Change from Baseline skin redness at 12 weeks |
| The change of skin melanin index | Mexameter® MX18 (CK, Germany) was utilized to measure face skin melanin level. Units: arbitrary units | Change from Baseline skin melanin index at 12 weeks |
| The change of skin elasticity | Skin elasticity (Softplus, Italy) was utilized to measure face skin elasticity. Units: arbitrary units | Change from Baseline skin elasticity at 12 weeks |
| The change of brown spots | VISIA Complexion Analysis was utilized to measure brown spots on face. Units: the amount of detectable brown spots | Change from Baseline brown spots at 12 weeks |
| The change of wrinkles around the eyes | VISIA Complexion Analysis was utilized to measure wrinkles around the eyes. Units: the amount of detectable wrinkles | Change from Baseline wrinkles around the eyes at 12 weeks |
| The change of skin texture | VISIA Complexion Analysis was utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 12 weeks |
| The change of skin collagen density | DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units | Change from Baseline skin collagen density at 12 weeks |
| The change of total antioxidation capacity (TAC) | A fasting blood sample will be collected for TAC testing. | Change from Baseline TAC at 12 weeks |
| The change of Superoxide Dismutase (SOD) | A fasting blood sample will be collected for SOD testing. | Change from Baseline SOD at 12 weeks |
| The change of Glutathione S-transferase-Red Blood Cells (GST-RBC) | A fasting blood sample will be collected for GST-RBC testing. | Change from Baseline GST-RBC at 12 weeks |
| The change of Malondialdehyde (MDA) | A fasting blood sample will be collected for MDA testing. | Change from Baseline MDA at 12 weeks |
Fatigue Symptom Inventory (FSI) was collected and evaluate fatigue level. Most items are rated on an 11-point Likert scale ranging from 0 to 10. The scores are generally averaged to create subscales for intensity and interference. |
| Change from Baseline fatigue level at 12 weeks |
| The change of self-assessment Low Immunity level | Low Immunity level was evaluated using a 5-point Likert scale (0-4) to assess the severity of Low Immunity-related symptoms. The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe. | Change from Baseline Low Immunity level at 12 weeks |
| The change of blood liver function biomarkers (AST, ALT) | A fasting blood sample will be collected for liver function biomarkers testing. | Change from Baseline liver function biomarkers at 12 weeks |
| The change of blood renal function biomarkers (creatinine, BUN) | A fasting blood sample will be collected for renal function biomarkers testing. | Change from Baseline renal function biomarkers at 12 weeks |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |