UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009324 |
|---|---|
| Receipt number | R000010911 |
| Scientific Title | Development of phosphatemic index and explore lower phosphate-loading food |
| Date of disclosure of the study information | 2012/12/26 |
| Last modified on | 2012/11/13 12:56:08 |
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Basic information
Public title
Development of phosphatemic index and explore lower phosphate-loading food
Acronym
Development of phosphatemic index
Scientific Title
Development of phosphatemic index and explore lower phosphate-loading food
Scientific Title:Acronym
Development of phosphatemic index
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of food selection tool helping to carry out low phosphors and high protein score diet must be useful to treat hyperphosphatemia and protein-energy wasting in chronic kidney disease patients. Glycemic index (GI) has been established and available to improve post-prandial hyperglycemia. GI is also utilized to develop a novel functional food. In this study, we investigate the difference of post-prandial serum phosphate increase or urinary phosphate excretion when different representative foods are ingested in healthy young volunteers. The goal of this study is establish the phosphatemic index of foods, and exploration and development of the low phosphatemic index foods.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
post-prandial serum phosphate, post-prandial urinary phosphate excretion, post-prandial intact-PTH, and post-prandial endothelial function (FMD and/or endo-PAT)
Key secondary outcomes
Post-prandial blood glucose, serum creatinine, blood urea nitrogen, blood pressure, serum Na, K, Cl, Ca, triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol, uric acid, insulin, 1,25-dihydroxyvitamin D, FGF23, urinary creatinine excretion, urinary Na excretion, urinary K excretion, urinary Ca excretion.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Experimental period: 2 years
Number of times: single dose, 30 times (at least 1 week interval)
Test article: commercially available foods (30 different foods) containing 200 mg phosphate.
A subject are received 30 different foods randomly and crossover, then evaluated post-prandial serum phosphate, urinary phosphate excretion, and serum intact-PTH changes.
Interventions/Control_2
Experimental period: 1 day
Number of times: single dose
Test article: 200 mg phosphate supplement
A subject are received 200 mg of phosphate supplement, then evaluated post-prandial serum phosphate, urinary phosphate excretion, and serum intact-PTH changes.
Interventions/Control_3
Experimental period: 1 month
Number of times: single dose, 4 times, dose-response
Test article: 50, 100, 200 , 300 mg phosphate containing food.
A subject are received food containing different amount of phosphate (50, 100, 200, 300 mg), then evaluated post-prandial serum phosphate, urinary phosphate excretion, and serum intact-PTH changes.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy young men and women (20-39 years old). Subjects should not be: BMI=25 or higher, smoker, under pregnancy and lactation.
Key exclusion criteria
Following subject(s) should be excluded: history or under treatment of heart disease, kidney disease, liver disease, gastrointestinal disease, brain disease, diabetes, hypertension and/or dyslipidemia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Taketani |
Organization
University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Clinical Nutrition
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL
+81-88-633-9597
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Taketani |
Organization
University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Clinical Nutrition
Zip code
Address
3-18-15, Kuramoto-cho, Toksuhima 770-8503, Japan
TEL
+81-88-633-9597
Homepage URL
taketani@nutr.med.tokushima-u.ac.jp
Sponsor or person
Institute
Department of Clinical Nutrition, Institute of Health Biosciences, University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical, Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Grant-in-aid for Scientific Research (KAKENHI) from MEXT, Japan.
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
徳島大学大学院ヘルスバイオサイエンス研究部臨床栄養学分野
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 13 | Day |
Last modified on
| 2012 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010911
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