Clinical trial NCT04438486: Effects of Barley Green in Patients With Hyperuricemia
Official title: Effects of Barley Green in Patients With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dietary Supplement
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jinhua Municipal Central Hospital
name: Quzhou Kecheng People's Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Zhejiang Cancer Hospital
name: Beijing Shijitan Hospital, Capital Medical University
First posted: 2020-06-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: uric acid level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua municipal central hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou Kecheng People's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The first affiliated hospital of Wenzhou medical university
state: Zhejiang
city: Beijing
country: China
facility: Beijing Shijitan Hospital
Study officials:
References: