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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031919
Receipt No. R000036451
Scientific Title The influence of protein density in very low calorie diet during rapid weight loss on body composition and mental status: a parallel group comparison study
Date of disclosure of the study information 2018/03/28
Last modified on 2019/04/18

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Basic information
Public title The influence of protein density in very low calorie diet during rapid weight loss on body composition and mental status: a parallel group comparison study
Acronym Protein density in very low calorie diet and body composition/ mental status
Scientific Title The influence of protein density in very low calorie diet during rapid weight loss on body composition and mental status: a parallel group comparison study
Scientific Title:Acronym Protein density in very low calorie diet and body composition/ mental status
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the influence of protein density in VLCD (4% or 40% energy) during rapid-weight loss without exercise on body composition and cognitive mental stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Body composition
Key secondary outcomes Mental status.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 VLCD with a protein density of 4 %EN for 5 days
Interventions/Control_2 VLCD with a protein density of 4 %EN for 5 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
40 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.
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 vegetable, fruit or dairy product.
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 are postmenopausal.
18.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 Yoshio
Middle name
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 270-1695
Address 1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL +81476981001
Email yssuzuki@juntendo.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Suzuki
Organization Juntendo University
Division name Graduate School of Health and Sports Science
Zip code 270-1695
Address 1-1, Hiragagakuendai, Inzai, Chiba, 270-1695 Japan
TEL +81476981001
Homepage URL
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University
Graduate School of Health and Sports Science
Institute
Department

Funding Source
Organization gram3.Inc.
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 Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address 1-1, Hiragagakuenndai, Inzai, Chiba, Japan
Tel +81476981001
Email sc-kyomu@juntendo.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 順天堂大学さくらキャンパス(千葉県)、関口クリニック(千葉県)、フォレストビレッジ(千葉県)、【Juntendo University Sakura campus(Chiba), Sekiguchi Clinic (Chiba), Forest Village (Chiba)】

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 28 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 24
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
2018 Year 02 Month 28 Day
Date of IRB
2018 Year 02 Month 28 Day
Anticipated trial start date
2018 Year 03 Month 29 Day
Last follow-up date
2018 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036451

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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