UMIN-CTR Clinical Trial

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

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Body composition

Key secondary outcomes

physical/mental status

Study type

Interventional

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

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

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

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

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

Institute

Jntendo University, Graduate School of Health & Suports Science

Institute

Department

Personal name

Organization

Este Pro Labo Co.,Ltd.(Tokyo, Japan)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

08

Month

02

Day

Last modified on

2017

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032612