UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-ranging study to evaluate efficacy of amino acid mixture on body fat reduction in overweight adults
Title of the study (Brief title)	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	Yoshio Nakata
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba
TEL	029-853-3076
Email	nakata@md.tsukuba.ac.jp

Public contact
Name of contact person	Yoshio Nakata
Organization	University of Tsukuba
Division name	Faculty of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/28740413
Results	Compared with placebo, a medium or low dose of the amino acid mixture may facilitate abdominal fat reduction among overweight adults.
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