UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021481 |
|---|---|
| Receipt number | R000024778 |
| Scientific Title | Study of effect of food containing plant ingredient on postprandial serum uric acid |
| Date of disclosure of the study information | 2017/04/29 |
| Last modified on | 2017/03/22 11:14:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of effect of food containing plant ingredient on postprandial serum uric acid
Acronym
Study of food containing plant ingredient on postprandial serum uric acid
Scientific Title
Study of effect of food containing plant ingredient on postprandial serum uric acid
Scientific Title:Acronym
Study of food containing plant ingredient on postprandial serum uric acid
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of food containing plant ingredient on postprandial serum uric acid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum uric acid
Key secondary outcomes
Urinary uric acid
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food containing plant ingredient, 1 food
Interventions/Control_2
Food not containing plant ingredient, 1 food
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) individuals who are the age of 20 to less than the age of 65 years old.
(2)Individuals whose fasting serum uric acid levels are from 6.0 mg/dL to 7.0 mg/dL.
(3)Individuals giving written informed consent.
Key exclusion criteria
(1)Individuals who use oral medication or supplements or functional foods affecting uric acid metabolism.
(2)Individuals who is not suitable for subjects by pre-test questionnaire.
(3)Individuals who declare the allergy symptoms against test diets.
(4)Individuals who have a chronic disease and use medicines continuously.
(5)Individuals who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(6)Individuals who have a history of digestive disease affecting digestion and absorption.
(7)Individuals who are judged as unsuitable for the study based on the results of blood test.
(8)Individuals who are planned to participate in other clinical study.
(9)Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study.
(10)Individuals with excessive alcohol-drinking behaviors (over 20 g alcohol/day).
(11)Individuals who can't stop drinking for 3 days until the pre-check day and check days.
(12)Individuals who is diagnosed as severe anemia and not suitable for frequent collection of blood.
(13)Individuals who have under treatment or a history of drug addiction and/or alcoholism.
(14)Individuals who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(15)Individuals who are working for a functional food company.
(16)Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Saito |
Organization
Medical station clinic
Division name
Medical station clinic
Zip code
Address
3-12-8 Takaban Meguro-ku, Tokyo
TEL
03-6271-9140
j.saito@med-station.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruo Saito |
Organization
TTC Co., Ltd
Division name
Site Management Organization Division
Zip code
Address
1-10-10 Ebisu-nishi, Shibuya-ku, Tokyo
TEL
03-6455-0880
Homepage URL
t.saito@ttc-smo.jp
Sponsor or person
Institute
TTC Corporation
Institute
Department
Personal name
Funding Source
Organization
Kirin 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 | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2016 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Protocol No. 27055
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2017 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024778
