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

Primary Purpose

Anemia, Skin Condition

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minayo Yeast Drink Product
Sponsored by
Hangzhou Agile Groups Network Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring Minayo Iron-rich Yeast Drink, SOD, GSH

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Raison CMA LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minayo Yeast Drink Product

Arm Description

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.

Outcomes

Primary Outcome Measures

Change of Hemoglobin Concentration Level
The change of hemoglobin concentration level, g/L (110~150g/L for healthy female, 120~160g/L for healthy male)

Secondary Outcome Measures

Superoxide Dismutase (SOD) Concentration Level
The change of Superoxide dismutase (SOD) concentration in blood, U/ml (1000~2000U/ml)
Glutathione (GSH) Concentration Level
The change of Glutathione (GSH) concentration level in blood, mg/L (280~380mg/L)
Skincare Measurement - Lines/Wrinkles
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Hangzhou Agile Groups Network Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06066151
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Agile Groups Network Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 hemoglobin concentration 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Skin Condition
Keywords
Minayo Iron-rich Yeast Drink, SOD, GSH

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minayo Yeast Drink Product
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Minayo Yeast Drink Product
Intervention Description
Participants need to drink one piece of the products each day, for 4 consecutive weeks.
Primary Outcome Measure Information:
Title
Change of Hemoglobin Concentration Level
Description
The change of hemoglobin concentration level, g/L (110~150g/L for healthy female, 120~160g/L for healthy male)
Time Frame
baseline day, end of week 4
Secondary Outcome Measure Information:
Title
Superoxide Dismutase (SOD) Concentration Level
Description
The change of Superoxide dismutase (SOD) concentration in blood, U/ml (1000~2000U/ml)
Time Frame
baseline day, end of week 4
Title
Glutathione (GSH) Concentration Level
Description
The change of Glutathione (GSH) concentration level in blood, mg/L (280~380mg/L)
Time Frame
baseline day, end of week 4
Title
Skincare Measurement - Lines/Wrinkles
Description
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system
Time Frame
baseline day, end of week 4

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females, aged 18 to 35
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@raisonbiotech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlie Zhang, MD
Organizational Affiliation
Raison Biotech Co., Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Raison CMA Lab
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@raisonbiotech.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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