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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028718
Receipt No. R000032841
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group study to investigate the hypouricemic effect of anserine ingestion
Date of disclosure of the study information 2017/08/19
Last modified on 2018/09/05

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Basic information
Public title A randomized, double-blind, placebo-controlled, parallel-group study to investigate the hypouricemic effect of anserine ingestion
Acronym Hypouricemic effect of anserine ingestion
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group study to investigate the hypouricemic effect of anserine ingestion
Scientific Title:Acronym Hypouricemic effect of anserine ingestion
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of anserine ingestion for 12 weeks on postprandial uric acid after loading purine-rich diet
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Serum uric acid at 4-week, 8-week, 12-week consumption
Key secondary outcomes Uric acid excretion in the urine, 8-OHdG in the urine, questionnaire of daily habit, SF-8 and visual analogue scale to evaluate fatigue severity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement containing anserine for 12 weeks
Interventions/Control_2 Ingestion of placebo without anserine for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy males and females aged 20 to 64 years old
2.Individuals whose serum uric acid are from 5.5 mg/dL to 7.0 mg/dL
3.Individuals who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria 1.Individuals who use medications affecting uric acid metabolism
2.Individuals who cannot stop using supplements and/or functional foods affecting serum uric acid
3.Individuals who contract hyperuricemia needing treatment
4.Individuals who have a history of gout or are under treatment of gout
5. Individuals who have drinking habit more than 60 g in terms of pure alcohol a day for more than 5 days a week
6. Individuals who cannot stop drinking from 2 days before visit
7. Individuals who have a history of food allergy
8. Individuals who are under treatment or have a history of disease e.g., serious hyperlipidemia, diabetes, kidney disease, liver disease, or heart disease., thyroid disease, adrenal disease, or metabolic diseases
9. Individuals who use a medicine
10. Individuals who have chronic disease and regularly use medicines
11. Individuals who have a history of gastroenterological disease or operation on digestive organ
12.Individuals who are judged as unsuitable for the study because of the result of blood chemistry and hematology test at screening test
13.Individuals who have donated blood components and/or blood a volume of 200 mL and over within one month prior to the current study
14. Individuals who have under treatment or a history of drug addiction and/or alcoholism
15.Individuals who are planning to participate or already participating in other clinical studies
16.Individuals who are judged as unsuitable for the study by the investigator for other reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Yaizu Suisankagaku Industry Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Oral administration of anserine has hypouricemic activity with no undesirable side effects.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 18 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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