Evaluating a Yeast Drink for Improving Anemia and Skin Conditions in Young Women

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

This study is testing if a special iron-rich yeast drink can help young women with anemia and skin problems feel better after drinking it daily for four weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Hangzhou Agile Groups Network Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06066151 on ClinicalTrials.gov

What this trial studies

This open-label study aims to assess the efficacy of Minayo Iron-rich Yeast Drink with SOD in females aged 18-35 suffering from nutritional anemia, skin conditions, and Qi-blood deficiency syndrome. Fourteen participants will consume the drink daily for four weeks, with four site visits to monitor clinical data. The primary outcome is to determine if serum ferritin levels improve post-intervention by comparing blood test results before and after the treatment.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 35 with hemoglobin levels below 110g/L due to nutritional anemia.

Not a fit: Patients with anemia caused by organic diseases or those with gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve anemia and skin conditions in young women.

How similar studies have performed: While similar approaches have been explored, this specific intervention using Minayo Iron-rich Yeast Drink with SOD is novel.

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Raison CMA Lab — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Charlie Zhang, MD — Raison Biotech Co., Ltd.
• Study coordinator: Charlie Zhang, MD

Conditions Anemia; Skin Condition; Minayo Iron-rich Yeast Drink; SOD; GSH