NCT06066151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

29 days

First QC Date

September 27, 2023

Last Update Submit

September 9, 2025

Conditions

Keywords

Minayo Iron-rich Yeast DrinkSODGSH

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hemoglobin Concentration Level

    baseline day, end of week 4

  • Superoxide Dismutase (SOD) Concentration Level

    baseline day, end of week 4

  • Glutathione (GSH) Concentration Level

    baseline day, end of week 4

  • Skincare Measurement - Lines/Wrinkles

    baseline day, end of week 4

Study Arms (1)

Minayo Yeast Drink Product

EXPERIMENTAL

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

Interventions

Minayo Yeast Drink ProductDIETARY_SUPPLEMENT

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

Minayo Yeast Drink Product

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales, aged 18 to 35
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Raison CMA Lab

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

AnemiaSkin Diseases

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Charlie Zhang, MD

    Raison Biotech Co., Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 4, 2023

Study Start

September 10, 2023

Primary Completion

October 9, 2023

Study Completion

December 15, 2023

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations