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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048081
Receipt No. 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 2022/06/17

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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
Email 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
Email masakiyoshioka1129@gmail.com

Sponsor
Institute Factory of Health and Sports Science, University of Tsukuba
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 10 Month 31 Day
Date of closure to data entry
2022 Year 10 Month 31 Day
Date trial data considered complete
2022 Year 11 Month 30 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2022 Year 06 Month 17 Day
Last modified on
2022 Year 06 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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