The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066151
• Other study ID #: 23-RD-09-MY-001
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: Hangzhou Agile Groups Network Technology Co., Ltd.
• Contact: Charlie Zhang, MD
• Phone: +8613901981272
• Email: charlie.zhang[@]raisonbiotech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 15, 2023
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Disease
• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Minayo Yeast Drink Product
Participants need to drink one piece of the products each day, for 4 consecutive weeks.

Locations

Country	Name	City	State
China	Shanghai Raison CMA Lab	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Agile Groups Network Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Hemoglobin Concentration Level	The change of hemoglobin concentration level in blood, g/L (115-150g/L)	baseline day, end of week 4
Secondary	Superoxide Dismutase (SOD) Concentration Level	The change of Superoxide dismutase (SOD) concentration in blood, U/ml (1000~2000U/ml)	baseline day, end of week 4
Secondary	Glutathione (GSH) Concentration Level	The change of Glutathione (GSH) concentration level in blood, mg/L (280~380mg/L)	baseline day, end of week 4
Secondary	Skincare Measurement - Lines/Wrinkles	The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system	baseline day, end of week 4