UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028718 |
|---|---|
| Receipt number | 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 15:39:42 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032841
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
