Effects of Barley Green in Patients With Hyperuricemia

Dietary Supplement Clinical Trial

Official title:

Effects of Barley Green in Patients With Hyperuricemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04438486
• Other study ID #: 2019-411
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pianhong Zhang, MS
• Phone: +86057187783852
• Email: zrlcyyzx[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This experiment evaluates the effect of Barley Green in patients with hyperuricemia ， and explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids, blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm B will receive dietary guidance and Barley Green.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years old those who are willing to accept assessment and sign informed consent.

• Under the normal purine diet, two fasting blood uric acid levels on different days:

420umol/l <blood uric acid <540 umol/l (male), 360 umol/l <blood uric acid <540 umol/l (female)

Exclusion Criteria:

• Patients currently receiving treatment for hyperuricemia;

• Suffering from diseases that affect the digestion and absorption(such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcers, after gastrointestinal resection, cholecystitis/cholecystectomy, etc.);

• Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases;

• At the same time receive other functional food nutrition support (plant active substances, health food);

• Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal renal function (serum creatinine exceeds the upper limit of normal value);

• Suffering from infectious diseases such as active tuberculosis and AIDS;

• People who are severely allergic to the ingredients of research;

• During pregnancy or lactation;

• Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, suffering from serious diseases not included in the discharge criteria);

• Gouty arthritis attack = 2 times;

• One episode of gouty arthritis with blood uric acid >480 umol/l, or any of the following: age <40 years old, evidence of gout stone or urate deposition in the joint cavity, uric acid nephrolithiasis or renal impairment (GFR=89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency;

• Blood uric acid>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal impairment (GFR=89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.

Related Conditions & MeSH terms

• Dietary Supplement
• Hyperuricemia

Intervention

Behavioral:
• Group A
specific dietary advice for Hyperuricemia

Dietary Supplement:
• Group B
Barely Green(three times a day, 5g(10 tablets)) dietary advice for Hyperuricemia as Group A

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital	Beijing
China	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang cancer hospital	Hangzhou	Zhejiang
China	Jinhua municipal central hospital	Jinhua	Zhejiang
China	Quzhou Kecheng People's Hospital	Quzhou	Zhejiang
China	The first affiliated hospital of Wenzhou medical university	Wenzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Beijing Shijitan Hospital, Capital Medical University, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uric acid level		3 months