UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053812 |
|---|---|
| Receipt number | R000058922 |
| Scientific Title | Validation of an effective diet composition for improving postprandial hyperphosphatemia |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/03/09 11:46:35 |
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Basic information
Public title
Validation of an effective diet composition for improving postprandial hyperphosphatemia
Acronym
Validation of an effective diet composition for improving postprandial hyperphosphatemia
Scientific Title
Validation of an effective diet composition for improving postprandial hyperphosphatemia
Scientific Title:Acronym
Validation of an effective diet composition 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 effects of dieta with widley differing protein sources on human phosphorus metabolsim and blood glucose variability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the dynamics of phosphorus metabolism after consumption of diets with widely fifferent protein sources,urinary phosphorus concentraiton and CPP (calciprotien particles) will be measured before and after the meal.
Key secondary outcomes
To examine postprandial blood glucose variability before and after meal ingestion to examine postprandial blood glucose variability after ingestion of meals with widely different protein sources.
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One meal containing 17.2 g protein/722.7 kcal. This will be the reference meal .
Interventions/Control_2
Consume one meal adjusted to contain 70% vegetable protein and 30% animal protein out of the dietary protein (25.2 g/718.9 kcal).
Interventions/Control_3
Consume one meal adjusted to include 30% vegetable protein and 70% animal protein out of the dietary protein (24.5 g/737.9 kcal).
Interventions/Control_4
One meal containing 8.7 g protein/728.2 kcal. This will be the reference meal.
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) 18 years of age or older
(2) No renal function problems (eGFR > 60 ml/min/1.73 m2)
(3) No glucose tolerance problems
(4) Normal serum phosphorus concentration
(5) Must not have any allergies to the food to be served
(6) Must be able to give informed consent
Target sample size
40
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
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
skido@nara.kindai.ac.jp
Sponsor or person
Institute
KINDAI University
Institute
Department
Personal name
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
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
| 2024 | Year | 03 | Month | 30 | 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
35
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
| 2023 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058922
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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