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

Sponsor

Hangzhou Agile Groups Network Technology Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06066151

Collaborator

(none)

Enrollment

Location

Arm

3.2

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Skin Condition	Dietary Supplement: Minayo Yeast Drink Product	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

Nov 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Minayo Yeast Drink Product Participants need to drink one piece of the products each day, for 4 consecutive weeks.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Minayo Yeast Drink Product

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

Outcome Measures

Primary Outcome Measures

Change of Hemoglobin Concentration Level [baseline day, end of week 4]
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 [baseline day, end of week 4]
The change of Superoxide dismutase (SOD) concentration in blood, U/ml (1000~2000U/ml)
Glutathione (GSH) Concentration Level [baseline day, end of week 4]
The change of Glutathione (GSH) concentration level in blood, mg/L (280~380mg/L)
Skincare Measurement - Lines/Wrinkles [baseline day, end of week 4]
The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.