Clinical trial NCT06066151: The Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia
Skin Condition
Keywords: Minayo Iron-rich Yeast Drink
SOD
GSH
Lead sponsor: Hangzhou Agile Groups Network Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change of Serum Ferritin Level
timeFrame: baseline day, end of week 4
Secondary outcomes:
measure: Hemoglobin Concentration Level
timeFrame: baseline day, end of week 4
measure: Superoxide Dismutase (SOD) Concentration Level
timeFrame: baseline day, end of week 4
measure: Glutathione (GSH) Concentration Level
timeFrame: baseline day, end of week 4
measure: Skincare Measurement - Lines/Wrinkles
timeFrame: baseline day, end of week 4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Raison CMA Lab
state: Shanghai
Study officials:
affiliation: Raison Biotech Co., Ltd.
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: