UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of protein intake during rapid weight loss on body composition and mental stress:a parallel group comparison study
Title of the study (Brief title)	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	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
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	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health and Sports Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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