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The goal of this randomized, double-blind, placebo controlled study is to learn about the efficacy of Minayo Iron-rich Nutritional Gummies on females who are aged 18-45 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is:
- whether the Anemia (measured by serum ferritin level and hemoglobin concentration Level in blood) is improved after the intervention
36 qualified participants will be enrolled and assigned to two equal-size groups with study product (Minayo Iron-rich Nutritional Gummies) and placebo product (common gummies) in one study center in Shanghai. The study will last 4 weeks and three site visits will be made, during which all clinical data will be captured and entered to EDC system for statistical analysis and reporting.
Researchers will find out whether the study product (Minayo Iron-rich Nutritional Gummies) is effective to improve Anemia, skin conditions, and Qi-blood deficiency symptoms by comparing the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minayo Iron-rich Nutritional Gummies | Active Comparator | Minayo Iron-rich Nutritional Gummies, 3g/piece, each piece contains 7mg of iron. Main ingredients: Maltitol liquid, isomaltitol, erythritol, gelatin, ferrous gluconate, ferrous fumarate, ferric ammonium citrate, acerola cherry powder, cranberry powder, red beetroot powder, raspberry powder, acai powder, salmon hydrolyzed protein peptides, blood protein polypeptides, albumin peptides, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin C, α-cyclodextrin, purple carrot concentrated juice, grape skin extract, agar, citric acid, DL-malic acid, natural food flavoring, octane, glyceryl caprate, and carnauba wax .. |
|
| Common Gummies | Placebo Comparator | common gummies with main ingredient - Maltodextrin, 3g/piece |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minayo Iron-rich Nutritional Gummies | Dietary Supplement | Participants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Serum Ferritin Level | The change of serum ferritin level in blood, ng/mL (12~135ng/mL for healthy female, 27~375ng/mL for healthy male) | baseline day, end of week 4 |
| Change of Hemoglobin Concentration Level | The change of hemoglobin concentration level in blood, g/L (115-150g/L) | baseline day, end of week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Facial image capturing and analysis | The facial images capturing and analysis by VISIA-CR® imaging system, the degree of facial ruddiness/redness, number of wrinkle lines | baseline day, end of week 4 |
| Change of hand temperature |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects, aged 18 to 45
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| Name | Affiliation | Role |
|---|---|---|
| Charlie Zhang, MD | Raison Biotech Co., Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Raison CMA Lab | Shanghai | Shanghai Municipality | China |
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| Common Gummies | Dietary Supplement | Participants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks. |
|
The change of hand temperature in celsius degree measured by FLIR E60 thermal imaging camera
| baseline day, end of week 4 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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