Effects of black bone chicken consumption on uricemia in healthy volunteer

Phase 1

Recruiting

• Conditions: Healthy volunteers with serum uric acid level more than 5 mg/dl; Black bone chicken, Gout, Hyperuricemia, Functional food

• Registration Number: TCTR20240403004
• Lead Sponsor: Office of National Higher. Education Science Research and Innovation Policy Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Last Update Posted: 19 August 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

1. Healthy male with age more than 20 years old.
2. Volunteers must read, communicate and write Thai language.
3. Volunteers have a willingness to participate in the study after being informed.
4. Volunteers are willing to perform activities or avoid activities according to the guidelines.
Volunteers have clinical laboratory test values of kidney function within normal limits (eGFR more than or equal to60 mL/min/1.73m2 by CKD-EPI) and liver function values within normal limits, including FBS and HbA1c values.
5. Volunteers have a blood uric acid level more than 5 mg/dl

Exclusion Criteria

1. Volunteers have a history of allergy to chicken products (chicken meat or chicken ingredients) or seasonings that are ingredients of the products, such as soybeans, wheat, seasoning powder, salt, shiitake mushroom powder, etc.
2. Volunteers have a history of taking medicine or dietary supplements that have the ability to stimulate or decrease kidney function or may affect the uric acid level in the blood.
3. Volunteers have a disease that requires taking medicine continuously on a regular basis.
4. Volunteers have a history of major surgery within the past 1 year.
5. Volunteers have a history of regularly drinking alcoholic beverages (at least 1 glass per day, or approximately 250 ml).
6. Volunteers have a history of participating in other research projects which is a test of dietary supplements, oral medicine for less than 1 month before participating the project or is currently undergoing testing.
7. Volunteers whose serum uric acid value changes by more than 15 percent (after repeated testing within 7 days) or volunteers whose serum uric acid value changes by no more than 15 percent (after repeated testing within 7 days) but blood uric acid level less than or equal 5 mg/dL.
8. There is a change in kidney function values of more than 25 percent (after repeated testing within 7 days).
9. Volunteers ate foods that affect blood uric acid levels 2 days before coming to have their blood drawn. The foods that affect the uric acid level in the blood include energy drinks, vitamin C or dietary supplements or products obtained from milk such as cheese, milk, yogurt, fruit juice, cherries, etc.
10. Volunteers drank more than 2 cups of tea, coffee, both caffeinated and non-caffeinated per day.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum uric acid at day 0, 7, 14 and 21 Blood test,24 hour urine uric acid at day 0, 7, 14 and 21 Urine test,24 hour urine creatinine at day 0, 7, 14 and 21 Urine test

Secondary Outcome Measures

Name	Time	Method
Kidney function: Blood urea nitrogen (BUN), Creatinine, Estimated Glomerular filtration rate (eGFR) at day 0, 7, 14 and 21 Blood and urine test,Liver function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) at day 0, 7, 14 and 21 Blood test,Serum Xanthine oxidase activity at day 0, 7, 14 and 21 Blood test