Last updated: December 13, 2023
Sponsor: Hangzhou Agile Groups Network Technology Co., Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Anemia
Treatment
Minayo Yeast Drink Product
Clinical Study ID
NCT06066151
23-RD-09-MY-001
Ages 18-35 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female, aged 18 to 35;
- Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria foranemia;
- 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 thetrial;
- Willing to refrain from participating in other interventional clinical studies duringthe trial period;
- Be able to fully understand the purpose, benefits and potential risks including sideeffects of the research;
- Willing to obey all test requirements and procedures;
- Informed consent signed.
Exclusion
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 intestinalfunction, such as history of gastrointestinal resection, colon or rectal cancer,inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenitalmegacolon, scleroderma, anorexia nervosa, etc.;
- Controlling diet, exercising, or taking medications to control weight or affectappetite in the last 3 months;
- Subject who has any of the following medical history or clinical findings that mayaffect 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 maycause bowel dysfunction or can affect test result evaluation;
- Frequently use of medications that may affect gastrointestinal function or the immunesystem according to investigator's judgment;
- Take laxatives or other substances that promote digestion 2 weeks before the trailstart;
- Subject who used drugs or supplements of iron agent 10 days before the beginning ofthe 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.
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Minayo Yeast Drink Product
Phase:
Study Start date:
September 10, 2023
Estimated Completion Date:
December 15, 2023
Connect with a study center
Shanghai Raison CMA Lab
Shanghai, Shanghai
ChinaActive - Recruiting
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