The Efficacy of Minayo Iron-rich Nutritional Gummies on Female Anemia, Skin Condition and Qi-blood Deficiency Syndrome

NCT06869824 | Completed

• 1 other identifier: 25-RD-01-MY-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized, double-blind, placebo controlled study is to learn about the efficacy of Minayo Iron-rich Nutritional Gummies on females who are aged 18-45 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is: \- whether the Anemia (measured by serum ferritin level and hemoglobin concentration Level in blood) is improved after the intervention 36 qualified participants will be enrolled and assigned to two equal-size groups with study product (Minayo Iron-rich Nutritional Gummies) and placebo product (common gummies) in one study center in Shanghai. The study will last 4 weeks and three site visits will be made, during which all clinical data will be captured and entered to EDC system for statistical analysis and reporting. Researchers will find out whether the study product (Minayo Iron-rich Nutritional Gummies) is effective to improve Anemia, skin conditions, and Qi-blood deficiency symptoms by comparing the two groups.

Conditions

Anemia; Skin Condition; Qi-blood Deficiency Syndrome

Keywords

Minayo; Iron-rich Nutritional Gummies; Serum ferritin; Hemoglobin

Outcome Measures

Primary Outcomes (2)

• 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

• Change of Hemoglobin Concentration Level

  The change of hemoglobin concentration level in blood, g/L (115-150g/L)

  baseline day, end of week 4

Secondary Outcomes (2)

• Facial image capturing and analysis

  baseline day, end of week 4

• Change of hand temperature

  baseline day, end of week 4

Study Arms (2)

Minayo Iron-rich Nutritional Gummies

ACTIVE COMPARATOR

Minayo Iron-rich Nutritional Gummies, 3g/piece, each piece contains 7mg of iron. Main ingredients: Maltitol liquid, isomaltitol, erythritol, gelatin, ferrous gluconate, ferrous fumarate, ferric ammonium citrate, acerola cherry powder, cranberry powder, red beetroot powder, raspberry powder, acai powder, salmon hydrolyzed protein peptides, blood protein polypeptides, albumin peptides, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin C, α-cyclodextrin, purple carrot concentrated juice, grape skin extract, agar, citric acid, DL-malic acid, natural food flavoring, octane, glyceryl caprate, and carnauba wax ..

Dietary Supplement: Minayo Iron-rich Nutritional Gummies

Common Gummies

PLACEBO COMPARATOR

common gummies with main ingredient - Maltodextrin, 3g/piece

Dietary Supplement: Common Gummies

Interventions

Minayo Iron-rich Nutritional Gummies DIETARY_SUPPLEMENT

Participants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks.

Minayo Iron-rich Nutritional Gummies

Common Gummies DIETARY_SUPPLEMENT

Participants need to eat one piece of the assigned product after meal three times a day, for 4 consecutive weeks.

Common Gummies

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female subjects, aged 18 to 45
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects, aged 18 to 45;
• young women with mild anemia (hemoglobin value between 90-110 g/l) were recruited based on WHO diagnostic criteria for anemia. 10 of the subjects always have coffee and milk tea more than once per day;
• Participants agree not to take any drugs, supplements, or other dairy products during the trial;
• Participants agree not to take any other medications or supplements containing iron during the trial;
• Antibiotics may be used unless medically required, but the type and dosage and days taken should be recorded;
• Willing to refrain from participating in other interventional clinical studies during the trial period;
• Fully understand the nature, purpose, benefits and possible risks and side effects of the study;
• Willing to obey all test requirements and procedures;
• Sign informed consent form.

You may not qualify if:

• Anemia due to organic conditions;
• 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 in 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.

Sponsors & Collaborators

• Hangzhou Agile Groups Network Technology Co., Ltd.: lead

Study Sites (1)

Shanghai Raison CMA Lab

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Anemia; Skin Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charlie Zhang, MD

  Raison Biotech Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: March 17, 2025
• Primary Completion: April 13, 2025
• Study Completion: April 13, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)