A Single Arm, Open-label Study of the Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change of Serum Ferritin Level
Study Overview
Brief Summary
The goal of this single arm, open-label study is to learn about the efficacy of Minayo Iron-rich Yeast Drink with SOD on females who are aged 18-35 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is:
- whether the serum ferritin level in blood is improved after the intervention
14 qualified participants will be enrolled to drink the product "Minayo Iron-rich Yeast Drink with SOD" for four weeks, once a day. Four site visits will be made for each participant so that all relevant clinical data will be captured and recorded for data analysis and reporting.
Researchers will compare the final blood test result (hemoglobin concentration level, Glutathione (GSH), Superoxide Dismutase (SOD)) against the baseline to conclude whether the product will be effective in improving Anemia and skin conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female, aged 18 to 35;
- •Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria for anemia;
- •Agree not to take any drugs, supplements, or other dairy products during the trial;
- •Agree not to take any other medications or supplements containing iron during the trial;
- •Willing to refrain from participating in other interventional clinical studies during the trial period;
- •Be able to fully understand the purpose, benefits and potential risks including side effects of the research;
- •Willing to obey all test requirements and procedures;
- •Informed consent signed.
Exclusion Criteria
- •Anemia caused by organic diseases;
- •Subject who is in the treatment of gastrointestinal symptoms;
- •Lactose intolerance;
- •Subject who is currently presence of other organic diseases affecting intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc.;
- •Controlling diet, exercising, or taking medications to control weight or affect appetite in the last 3 months;
- •Subject who has any of the following medical history or clinical findings that may affect the evaluation of the trial effect: significant gastrointestinal disorders, liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;
- •Abuse alcohol or other drugs, supplement or OTC drugs currently or n the past may cause bowel dysfunction or can affect test result evaluation;
- •Frequently use of medications that may affect gastrointestinal function or the immune system according to investigator's judgment;
- •Take laxatives or other substances that promote digestion 2 weeks before the trail start;
- •Subject who used drugs or supplements of iron agent 10 days before the beginning of the trial;
- •Pregnant or lactating women or those planning to become pregnant during the trial;
- •PI deems that subjects could not fully cooperate with trial arrangements.
Outcomes
Primary Outcomes
Change of Serum Ferritin Level
Time Frame: baseline day, end of week 4
The change of serum ferritin level in blood, ng/mL (12\~135ng/mL for healthy female, 27\~375ng/mL for healthy male)
Secondary Outcomes
- Superoxide Dismutase (SOD) Concentration Level(baseline day, end of week 4)
- Glutathione (GSH) Concentration Level(baseline day, end of week 4)
- Skincare Measurement - Lines/Wrinkles(baseline day, end of week 4)
- Hemoglobin Concentration Level(baseline day, end of week 4)