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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028497
Receipt No. R000032612
Scientific Title The influence of protein intake during rapid weight loss on body composition and mental stress:a parallel group comparison study
Date of disclosure of the study information 2017/08/04
Last modified on 2017/09/13

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Basic information
Public title The influence of protein intake during rapid weight loss on body composition and mental stress:a parallel group comparison study
Acronym The influence of protein intake during rapid weight loss
Scientific Title The influence of protein intake during rapid weight loss on body composition and mental stress:a parallel group comparison study
Scientific Title:Acronym The influence of protein intake during rapid weight loss
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the influence of protein intakes of 4% and 13% energy during rapid-weight loss without exercise on body composition and cognitive mental stress.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Body composition
Key secondary outcomes physical/mental status

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Energy restricted meal with 4 %EN of protein for 7 days
Interventions/Control_2 Energy restricted meal with 13 %EN of protein for 7 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 Female
Key inclusion criteria 1.Healthy female adults, aged 20 to 60 years
2.Subjects in good physical condition such that they can perform testing safely.
3.Subjects who are sedentary and not currently engaging in any regular exercise.
4.Subjects who agree to maintain their current level of activity throughout the trial period.
5.Subjects who have given voluntary, written, informed consent to participate in the study.

Key exclusion criteria 1.Subjects who are smokers.
2.Subjects who have experienced more than 5% of weight loss in the past 3 months prior to the screening day
3.Subjects diagnosed with heart problems or disease
4.Subjects with uncontrolled hypertension (> 159 mmHg).Subjects with history of seizure
6.Present or history of neurological disorders or significant psychiatric illness
7.Subjects with gout
8.Subject with significant heart, liver, kidney, blood or respiratory disease
9.Subjects with Type I or Type II diabetes
10.Subjects with unstable thyroid disease
11.Subjects who participated in another clinical study within 3 months of the screening visit
12.Subjects with an allergy or sensitivity to the investigational meal ingredient.
13.Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months
14.Subjects who currently consume greater than 2 standard alcoholic drinks per day.
15.Subjects who have participated in a clinical research trial within 30 days prior to randomization.
16.Subjects who are cognitively impaired and/or who are unable to give informed consent
17.Subjects who have abnormal laboratory results or any other medical or psychological condition.

Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
Address 1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL +81-476-98-1001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code
Address 1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL +81-476-98-1001
Homepage URL
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Jntendo University, Graduate School of Health & Suports Science
Institute
Department

Funding Source
Organization Este Pro Labo Co.,Ltd.(Tokyo, Japan)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 08 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 Completed
Date of protocol fixation
2017 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 05 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 08 Month 02 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032612

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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