Effects of Barley Green in Patients With Hyperuricemia

Not Applicable

• Conditions: Dietary Supplement
• Interventions: Behavioral: Group A; Dietary Supplement: Group B

• Registration Number: NCT04438486
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Status Verified: 2021-07
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-11
• Primary Completion: 2021-10-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary advice	Group A	-
dietary advice+ Barely Green	Group B	-

Primary Outcome Measures

Name	Time	Method
uric acid level	3 months

Trial Locations

Locations (6)

Jinhua municipal central hospital; 🇨🇳 Jinhua, Zhejiang, China

The first affiliated hospital of Wenzhou medical university; 🇨🇳 Wenzhou, Zhejiang, China

Zhejiang cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China

Quzhou Kecheng People's Hospital; 🇨🇳 Quzhou, Zhejiang, China

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, China