Effects of Barley Green in Patients With Hyperuricemia

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04438486

Collaborator

Jinhua Municipal Central Hospital (Other), Quzhou Kecheng People's Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), Zhejiang Cancer Hospital (Other), Beijing Shijitan Hospital, Capital Medical University (Other)

130

Enrollment

Locations

Arms

Anticipated Duration (Months)

21.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplement	Behavioral: Group A Dietary Supplement: Group B	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Barley Green in Patients With Hyperuricemia

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

uric acid level [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009
2	Zhejiang cancer hospital	Hangzhou	Zhejiang	China	310022
3	Jinhua municipal central hospital	Jinhua	Zhejiang	China	321000
4	Quzhou Kecheng People's Hospital	Quzhou	Zhejiang	China	324000
5	The first affiliated hospital of Wenzhou medical university	Wenzhou	Zhejiang	China	325000
6	Beijing Shijitan Hospital	Beijing		China	Beijing

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04438486

Other Study ID Numbers:

2019-411

First Posted:

Jun 18, 2020

Last Update Posted:

Aug 11, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperuricemia

Study Results

No Results Posted as of Aug 11, 2021