UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048081 |
|---|---|
| Receipt number | R000054804 |
| Scientific Title | Effects of a dietary weight loss program including the replacement of animal proteins with plant proteins on phosphorus metabolism: A randomized controlled trial |
| Date of disclosure of the study information | 2022/06/18 |
| Last modified on | 2023/07/04 14:00:59 |
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Basic information
Public title
Effects of a dietary weight loss program including the replacement of animal proteins with plant proteins on phosphorus metabolism: A randomized controlled trial
Acronym
A dietary weight loss program including the replacement of animal proteins with plant proteins
Scientific Title
Effects of a dietary weight loss program including the replacement of animal proteins with plant proteins on phosphorus metabolism: A randomized controlled trial
Scientific Title:Acronym
A dietary weight loss program including the replacement of animal proteins with plant proteins
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of a dietary weight loss program including the replacement of animal proteins with plant proteins
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Change in serum fibroblast growth factor 23 levels over three months
Key secondary outcomes
Change in estimated phosphate concentration of the proximal tubule fluid over three months
Change in urinary phosphorus excretion over three months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group-based weight loss support program and provision of weight-loss tools
Interventions/Control_2
Group-based weight loss support program, provision of weight-loss tools, support program to replace animal proteins with plant proteins, and provision of plant-based food
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Body mass index: 25-40 kg/m2
More than 1 year after menopause (only women)
No soy allergies
Can eat animal products
Can agree to the content of the study
Can participate in weight loss support program
Have a computer and understand basic operations such as email
Key exclusion criteria
Participation in a clinical trial during the previous 6 months
Have severe heart disease, cerebrovascular disease, and renal dysfunction
Drug treatment for diabetes
Having participated in one's family living together in this study
A medical doctor can not agree with participation in the study
Past smoking within 1 year
Giving problems to the progress of the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Keisei |
| Middle name | |
| Last name | Kosaki |
Organization
University of Tsukuba
Division name
Factory of Health and Sports Sciences
Zip code
3058574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-2683
kosaki.keisei.gm@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Yoshioka |
Organization
University of Tsukuba
Division name
Factory of Health and Sports Sciences
Zip code
3058574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
Homepage URL
masakiyoshioka1129@gmail.com
Sponsor or person
Institute
Factory of Health and Sports Science, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Green Culture, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of the Faculty of Health and Sport Sciences at the University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
029-853-2571
tg-kenkyurinri@un.tsukuba.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 | 06 | Month | 18 | 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
25
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
| 2022 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054804
