UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031919 |
|---|---|
| Receipt number | 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 15:03:23 |
* 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
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
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
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Graduate School of Health and Sports Science
Institute
Department
Personal name
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
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
Value
https://center6.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 |
