UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062808 |
|---|---|
| Receipt number | R000071905 |
| Scientific Title | Effect of Reduced Inorganic Phosphate Intake from Food Additives on Urinary Phosphate Excretion: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/09/03 18:08:28 |
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Basic information
Public title
Effect of Reducing Inorganic Phosphate from Food Additives on Urinary Phosphate Excretion
Acronym
IP-RED Study
Scientific Title
Effect of Reduced Inorganic Phosphate Intake from Food Additives on Urinary Phosphate Excretion: A Randomized Crossover Trial
Scientific Title:Acronym
IP-RED Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of reducing inorganic phosphate intake from food additives on 24-hour urinary phosphate excretion in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hour urinary phosphate excretion
Key secondary outcomes
1. Urinary nutritional biomarkers
2. Physical activity and sedentary behavior
3. Daily nutrient and dietary intake
4. Anthropometric variables
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention 1: Control condition
Participants consume the control experimental diet containing the usual amount of inorganic phosphate derived from food additives for one day.
Interventions/Control_2
Intervention 2: P-250 condition
Participants consume an experimental diet containing 250 mg less inorganic phosphate derived from food additives than the control diet for one day.
Interventions/Control_3
Intervention 3: P-100 condition
Participants consume an experimental diet containing 100 mg less inorganic phosphate derived from food additives than the control diet for one day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 18 years or older.
2. Individuals who have received a sufficient explanation of the study and provided written informed consent voluntarily.
3. Individuals who are able to comply with the study procedures, including consumption of the provided experimental diets and 24-hour urine collection.
Key exclusion criteria
1. Individuals with kidney disease, cardiovascular disease, diabetes mellitus, or other diseases that may affect participation in the study.
2. Individuals who regularly use medications or supplements that may affect phosphate, calcium, or sodium metabolism.
3. Individuals with allergies to any foods included in the experimental diets.
4. Individuals who are pregnant or breastfeeding.
5. Individuals judged by the investigators to be unsuitable for participation in the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shoya |
| Middle name | |
| Last name | Mori |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
1568502
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo, Japan
TEL
+81-3-5477-2453
sm208754@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Shoya |
| Middle name | |
| Last name | Mori |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
1568502
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo, Japan
TEL
+81-3-5477-2453
Homepage URL
sm208754@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Human Research Ethics Committees at Tokyo University of Agriculture
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo, Japan
Tel
+81-3-5477-2532
human@nodai.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
東京農業大学
Tokyo University of Agriculture
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 04 | 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
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071905
