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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033270
Receipt No. R000037933
Official scientific title of the study Effect of test supplement on postprandial serum uric acid: A double blinded, placebo controlled, and cross over study
Date of disclosure of the study information 2018/07/12
Last modified on 2018/07/04

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Basic information
Official scientific title of the study Effect of test supplement on postprandial serum uric acid: A double blinded, placebo controlled, and cross over study
Title of the study (Brief title) Effect of test supplement on postprandial serum uric acid
Region
Japan

Condition
Condition Healthy male adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to verify the effect of test supplement on postprandial serum uric acid.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Postprandial serum uric acid AUC
Key secondary outcomes Postprandial serum uric acid levels, urinary excretion of uric acid,
uric acid clearance, creatinine clearance, ratio of uric acid clearance to creatinine clearance

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single intake of test food- single intake of placebo
Interventions/Control_2 Single intake of placebo-single intake of test 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
Key inclusion criteria 1. Subjects aged from 20 to 65 years old
2. Subjects whose fasting serum uric acid level is between 5.0 mg/dL and 7.0 mg/dL at the screening examination.
Key exclusion criteria 1. Subjects who usually take some medicine, foods for specified health uses, foods with function claims, health foods, or cosmetics including active ingredients
2. Subjects who have been taking foods affecting the study results once a week or more
3. Subjects who have gout in the past or are currently receiving treatment for hyperuricemia or gout (including exercise therapy, dietary guidance)
4. Subjects who are under treatment or have history of diseases (urinary stone, kidney stone, rheumatoid arthritis) which may influence the outcome of the study
5. Subjects who routinely use analgesics (non-steroidal analgesics, steroidal analgesics, etc.).
6.Subjects who habitually do intense exercise such as marathon
7. Subjects who cannot carry out the procedures of various inspections to be carried out during the research as specified
8. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication therapy
9. Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
10. Subjects with allergies to the test food in the study
11. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening examination
12. Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
13. Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
14. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 44

Research contact person
Name of lead principal investigator Kei Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person Shingo Yamamichi
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Address 1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL 03-5459-5329
Homepage URL
Email s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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 メディカルステーションクリニック
医療法人愛世会 愛誠病院 上野クリニック

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 12 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 28 Day
Anticipated trial start date
2018 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037933

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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