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

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

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 Overview

• Status: Recruiting
• Conditions: Anemia; Skin Condition
• Intervention / Treatment: Dietary supplement: Minayo Yeast Drink Product

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlie Zhang, MD; Phone Number: +8613901981272; Email: charlie.zhang@raisonbiotech.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Raison CMA Lab
      • Contact: Charlie Zhang, MD; Phone Number: +8613901981272; Email: charlie.zhang@raisonbiotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minayo Yeast Drink Product; Minayo Iron-rich Yeast Drink with SOD, 385 pieces, 25ml/piece, each piece contains 13mg of iron. Main ingredients: Water, erythritol, jujube juice concentrate, Wolfberry juice concentrate, ferrous gluconate, olive powder, SOD yeast powder, yeast extract (including glutathione), artichoke, etc.	Dietary supplement: Minayo Yeast Drink Product; Participants need to drink one piece of the products each day, for 4 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Glutathione (GSH) Concentration Level	The change of Glutathione (GSH) concentration level in blood, mg/L (280~380mg/L)	baseline day, end of week 4
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
Hemoglobin Concentration Level	The change of hemoglobin concentration level in blood, g/L (115-150g/L)	baseline day, end of week 4

Collaborators and Investigators

• Sponsor: Hangzhou Agile Groups Network Technology Co., Ltd.
• Investigators: Principal Investigator: Charlie Zhang, MD, Raison Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Actual): October 9, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: SOD; GSH; Minayo Iron-rich Yeast Drink
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Disease; Anemia; Skin Diseases
• Other Study ID Numbers: 23-RD-09-MY-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No