NCT04438486

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 11, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

June 17, 2020

Last Update Submit

August 3, 2021

Conditions

Dietary Supplement

Outcome Measures

Primary Outcomes (1)

  • uric acid level

    3 months

Study Arms (2)

dietary advice

ACTIVE COMPARATOR
Behavioral: Group A

dietary advice+ Barely Green

EXPERIMENTAL
Dietary Supplement: Group B

Interventions

Group ABEHAVIORAL

specific dietary advice for Hyperuricemia

dietary advice
Group BDIETARY_SUPPLEMENT

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

dietary advice+ Barely Green

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Jinhua municipal central hospital

Jinhua, Zhejiang, 321000, China

RECRUITING

Quzhou Kecheng People's Hospital

Quzhou, Zhejiang, 324000, China

RECRUITING

The first affiliated hospital of Wenzhou medical university

Wenzhou, Zhejiang, 325000, China

RECRUITING

Beijing Shijitan Hospital

Beijing, Beijing, China

RECRUITING

Central Study Contacts

Pianhong Zhang, MS

CONTACT

+86057187783852zrlcyyzx@zju.edu.cn

Xiaoxu Huang, MS

CONTACT

+8618067961987xiaoxuhuang0909@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 18, 2020

Study Start

April 1, 2020

Primary Completion

October 1, 2021

Study Completion

July 1, 2022

Last Updated

August 11, 2021

Record last verified: 2021-07

Locations

CN(6)