Scaling production and clinical study of value-added products from by-product of Buk-Siam Maejo Hybrid catfish processing

Phase 1

• Conditions: Postmenopausal women; Calcium; Collagen; bone density; skin elasticity; menopausal women

• Registration Number: TCTR20231021002
• Lead Sponsor: niversity of Phayao and Maejo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-21
• Study Completion: 2023-10-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Menopausal woman volunteers aged 45-60 years
2. Good health, no swallowing problems. There were no serious illnesses or complications.
3. No history of receiving drugs in groups that suppress estrogen.
4. No history of regular consumption of alcoholic beverages or have used drugs
5. No history of smoking
6. Do not use anti-inflammatory drugs or antibiotics or steroid drugs. or did not receive any medication within 14 days before administration of the research product and do not continue to use or give it throughout the duration of the research project.
7. No use or intake of dietary supplements, vitamins or minerals, herbs, and/or birth control pills within 14 days prior to administration of the study product, and do not continue to use or give it throughout the duration of the research project.
8. Do not inject fillers or stem cells, fat cells, or botulinum injections. Area to be tested.
9. Never participated in any other clinical studies. within 30 days before joining the study
10. No blood donation within 90 days before joining the study.
11. Not planning to become pregnant during and for 1 month after the study.
12. Able to write, read and communicate in Thai.

Exclusion Criteria

1. Have a history of illness or symptoms of allergies, diabetes, cardiovascular disease, liver disease, kidney disease, gastrointestinal disease, blood disease and/or other diseases. that may affect education

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of Bio Calcium Plus and Collagen Peptide on bone mass 0, 2, 6 months Physical examination, Questionnaires, Check body composition

Secondary Outcome Measures

Name	Time	Method
The effect of Calcium Plus herbs and Collagen Peptides on skin moisture and hair loss 0, 2, 6 months Check calcium and estrogen in blood sample, Check biochemical of bone formation and reabsorption