UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019870 |
|---|---|
| Receipt number | R000022938 |
| Scientific Title | Dose-ranging study to evaluate efficacy of amino acid mixture on body fat reduction in overweight adults |
| Date of disclosure of the study information | 2015/11/21 |
| Last modified on | 2018/06/09 09:18:03 |
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Basic information
Public title
Dose-ranging study to evaluate efficacy of amino acid mixture on body fat reduction in overweight adults
Acronym
Dose-ranging study of amino acid mixture
Scientific Title
Dose-ranging study to evaluate efficacy of amino acid mixture on body fat reduction in overweight adults
Scientific Title:Acronym
Dose-ranging study of amino acid mixture
Region
| Japan |
Condition
Condition
Overweight
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and effective dose of amino acid mixture on body fat reduction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
3-month changes in abdominal fat areas
Key secondary outcomes
3-month changes in body weight, percent body fat, waist circumference, skinfold thickness, dietary intake, physical activity, triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol and tryglyceride including 4 major classes and 20 subclasses, number of lipoprotein particle, fasting plasma glucose, hemoglobin A1c, and insulin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Physical activity promotion and drink A (amino acid mixture 3000 mg)
Interventions/Control_2
Physical activity promotion and drink B (amino acid mixture 1500 mg)
Interventions/Control_3
Physical activity promotion and drink C (amino acid mixture 750 mg)
Interventions/Control_4
Physical activity promotion and placebo drink
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals who understand the purpose and contents of the study, have ability to provide written consent, and give the written informed consent form
2. Body mass index is 25 or more but less than 30
3. Indivuduals who have no regular exercise (at least 30 minutes twice a week in one year)
Key exclusion criteria
1. Current or past history of severe diseases
2. Heavy alcohol drinkers
3. Heavy smokers
4. Individuals who have extremely irregular dietary habits
5. Individuals who are pregnant or nursing or desire pregnancy during the study
6. Constant use or past history during the last 6 months of oral medication or supplements potentially affecting the study outcomes
7. Phenylketonuria, and hyperphenylalaninemia
8. Participation in other clinical studies during the last 6 months
9. Individuals who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Nakata |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3076
nakata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Nakata |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3076
Homepage URL
nakata@md.tsukuba.ac.jp
Sponsor or person
Institute
Food Science Research Laboratories, Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Food Science Research Laboratories, Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28740413
Number of participants that the trial has enrolled
Results
Compared with placebo, a medium or low dose of the amino acid mixture may facilitate abdominal fat reduction among overweight adults.
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
| 2015 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022938
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| Registered date | File name |
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| Registered date | File name |
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