UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050761 |
|---|---|
| Receipt number | R000057839 |
| Scientific Title | Effects of the intake of a "healthy diet" with different nutrient compositions on nutrient metabolic kinetics from the perspective of dietary acid-base load (PRAL). |
| Date of disclosure of the study information | 2023/04/05 |
| Last modified on | 2023/06/29 12:28:34 |
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Basic information
Public title
Research on the effect of adequate vegetable intake on metabolic indices.
Acronym
Effect of adequate vegetable intake on metabolic indices.
Scientific Title
Effects of the intake of a "healthy diet" with different nutrient compositions on nutrient metabolic kinetics from the perspective of dietary acid-base load (PRAL).
Scientific Title:Acronym
Effects of the intake of a "healthy diet" with different nutrient compositions on nutrient metabolic kinetics from the perspective of dietary acid-base load (PRAL). A
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of a healthy diet containing adequate amounts of protein and vegetables on metabolic indices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum low-density lipoprotein cholesterol concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test meal containing adequate vegetable for 5 days
Interventions/Control_2
Intake of the test meal that does not contain adequate vegetable for 5 days
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who received a sufficient explanation of the purpose and contents of the study, who have the capacity to consent, voluntarily volunteer with sufficient understanding, and agree to participate in the document.
Key exclusion criteria
1.Subjects who are allergic to any of the foods served during the study period
2.Those who take nutritional supplements
3.Currently, those who undergo medication for several diseases
4.Those who are heavy alcohol drinkers
5.Those who are smoker
6.Those who are pregnant or breastfeeding
7.Those who judged that the examination director and the test sharing doctor are inappropriate as subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5511
arai@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5511
Homepage URL
arai@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
The University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel
054-264-5103
tyous10@u-shizuoka-ken.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
| 2023 | Year | 04 | Month | 05 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 06 | 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
| 2023 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
