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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019870
Receipt No. 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

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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
Email 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
Email nakata@md.tsukuba.ac.jp

Sponsor
Institute Food Science Research Laboratories, Meiji Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022938

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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