UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028022
Receipt No. R000032087
Scientific Title Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Date of disclosure of the study information 2017/09/01
Last modified on 2017/06/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Acronym Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Scientific Title Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Scientific Title:Acronym Inhibitory effects of dietary soy and whey proteins on muscle atrophy
Region
Japan

Condition
Condition muscle atrophy
Classification by specialty
Geriatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is designed to elucidate the inhibitory effects of soy and whey proteins on muscle atrophy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes We will give whey protein (8 g/day) or whey + soy proteins (8 g/day) to bed-ridden patients with PS 2 or 3 for 28 days. We will measure the volume and strength of quadriceps muscles.
Key secondary outcomes We will also measure urinary amounts of 8OHDG and 3-methylhistidine.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
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 Treatment
Type of intervention
Food
Interventions/Control_1 Whey protein or
8 gram per day, 28 days, with lunch
Interventions/Control_2 Soy protein + whey protein
8 gram per day, 28 days, with lunch
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients in hospital or Patients with day service
Patients with Performance Score 2 or 3
Key exclusion criteria Patients with muscle diseases, chronic kidney diseases, diabetes, steroid treatment, allergy against soy or whey protein
Patients getting supplement of soy-derived foods
Pregnant women
Patients with pace maker
Patients with claustrophobia

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nikawa
Organization Tokushima University Graduate School
Division name Institute of Biomedical Sciences
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9248
Email nikawa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nikawa
Organization Tokushima University Graduate School
Division name Institute of Biomedical Sciences
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9248
Homepage URL
Email nikawa@tokushima-u.ac.jp

Sponsor
Institute Department of Nutritional Physiology, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

Funding Source
Organization Fuji Foundation for Protein Research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 01 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
2017 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2017 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.