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

NCT ID: NCT06066151

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-10
• Study Completion Date: 2023-12-15

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.

Conditions

Anemia; Skin Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Minayo Yeast Drink Product

Intervention Type: DIETARY_SUPPLEMENT

Participants need to drink one piece of the products each day, for 4 consecutive weeks.

Interventions

Minayo Yeast Drink Product

Participants need to drink one piece of the products each day, for 4 consecutive weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Agile Groups Network Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charlie Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Raison Biotech Co., Ltd.

Locations

Shanghai Raison CMA Lab

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

23-RD-09-MY-001

Identifier Type: -

Identifier Source: org_study_id