Effects of Barley Green in Patients With Hyperuricemia

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.

Study Overview

• Status: Recruiting
• Conditions: Dietary Supplement
• Intervention / Treatment: Behavioral: Group A; Dietary supplement: Group B

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pianhong Zhang, MS; Phone Number: +86057187783852; Email: zrlcyyzx@zju.edu.cn
• Study Contact Backup: Name: Xiaoxu Huang, MS; Phone Number: +8618067961987; Email: xiaoxuhuang0909@zju.edu.cn

Study Locations

• China
  • Beijing, China, Beijing
    • Recruiting
    • Beijing Shijitan Hospital
    • Contact: Hanping Shi; Phone Number: 01063926617
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Sa Ye; Phone Number: 057188122222
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Pianhong Zhang, MD; Phone Number: +86 057187783852; Email: zrlcyyzx@zju.edu.cn
    • Jinhua, Zhejiang, China, 321000
      • Recruiting
      • Jinhua municipal central hospital
    • Quzhou, Zhejiang, China, 324000
      • Recruiting
      • Quzhou Kecheng People's Hospital
      • Contact: Qiuxia Chen; Phone Number: 05708877120
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dietary advice	Behavioral: Group A; specific dietary advice for Hyperuricemia
EXPERIMENTAL: dietary advice+ Barely Green	Dietary supplement: Group B; Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
uric acid level	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: 2019-411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No