UMIN-CTR Clinical Trial

Basic information
Public title	Verification of effective dietary content for improving postprandial hyperphosphatemia
Acronym	Verification of effective dietary content for improving postprandial hyperphosphatemia
Scientific Title	Verification of effective dietary content for improving postprandial hyperphosphatemia
Scientific Title:Acronym	Verification of effective dietary content for improving postprandial hyperphosphatemia
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the impact of diets with widely differing protein sources on human phosphorus metabolic kinetics.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome endpoint of this study will be the measurement of blood and urinary phosphorus concentrations before and after dietary intake to determine the phosphorus metabolic kinetics of a diet with widely differing protein sources.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Consume one meal containing 70% plant protein and 30% animal protein out of total protein.
Interventions/Control_2	Consume one meal containing 30% plant protein and 70% animal protein out of total protein.
Interventions/Control_3	Consume one meal that contains 30% vegetable protein and 70% animal protein out of the total protein and the same amount of fiber as the Control 1 meal.
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	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who component to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria	(1) Be at least 18 years of age. (2) Have no problems with renal function (3) Normal serum phosphorus level (4) No allergy to the food to be served (5) Must be able to give informed consent.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Kido
Organization	KINDAI University
Division name	Laboratory of Clinical Nutrition, Department of Food Science and Nutrition, Faculty of Agriculture
Zip code	631-8505
Address	3327-204, Nakamachi, NARA 631-8505, JAPAN
TEL	0742-43-8006
Email	skido@nara.kindai.ac.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Kido
Organization	KINDAI University
Division name	Laboratory of Clinical Nutrition, Department of Food Science and Nutrition, Faculty of Agriculture
Zip code	631-8505
Address	3327-204, Nakamachi, NARA 631-8505, JAPAN
TEL	0742-43-8006
Homepage URL
Email	skido@nara.kindai.ac.jp

Sponsor
Institute	KINDAI University
Institute
Department

Funding Source
Organization	KINDAI University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Committee of Faculty of Agriculture, KINDAI University
Address	3327-204, Nakamachi, NARA 631-8505, JAPAN
Tel	0742-43-1894
Email	syomu-info@nara.kindai.ac.jp

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	2022 Year 10 Month 24 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	33
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	2015 Year 09 Month 01 Day
Date of IRB	2015 Year 09 Month 12 Day
Anticipated trial start date	2015 Year 09 Month 25 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 10 Month 18 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055870