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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025186
Receipt No. R000028965
Scientific Title Randomized controlled trial to examine efficacy on body fat reduction and safety of amino acid mixture during physical activity promotion in overweight adults
Date of disclosure of the study information 2016/12/10
Last modified on 2018/06/09

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Basic information
Public title Randomized controlled trial to examine efficacy on body fat reduction and safety of amino acid mixture during physical activity promotion in overweight adults
Acronym Efficacy of amino acid mixture during physical activity promotion
Scientific Title Randomized controlled trial to examine efficacy on body fat reduction and safety of amino acid mixture during physical activity promotion in overweight adults
Scientific Title:Acronym Efficacy of amino acid mixture during physical activity promotion
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 efficacy on body fat reduction and safety of amino acid mixture
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes 3-month changes in abdominal fat areas
Key secondary outcomes 3-month changes in body weight, percent body fat, waist circumference, hip circumference, waist-hip ratio, blood pressure, BMI, triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting plasma glucose, HbA1c, insulin, and HOMA-R

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 2
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 4 physical activity sessions and daily intake of placebo drink for 3 months
Interventions/Control_2 4 physical activity sessions and daily intake of test drink for 3 months
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Body mass index is 25 or more but less than 30 at the screening measurement
2. Individuals who understand the purpose and contents of the study, have ability to provide written consent, and give the written informed consent form
Key exclusion criteria 1. Constant use of oral medication potentially affecting body weight and lipid metabolism
2. Those who have severe hepatic disorder, cardiovascular disorder, breathing disorder, endocrine disorder, metabolism disorder, or food allergy
3. Those who cannot stop use of health food products or supplements potentially affecting body weight and lipid metabolism
4. Current or past history of drug or alcohol dependence
5. Those who cannot abstain from alcohol drinking for 2 days before measurements
6. Those who have some metal implanted in their abdominal site
7. With cardiac pacemaker or implanted defibrillator
8. Diagnosed with phenylketonuria or hyperphenylalaninemia
9. Diagnosed with familial hyperlipidemia
10. Those who are currently pregnant or nursing or desire pregnancy during the study
11. Those who have extremely irregular dietary habits or lifecycle such as midnight work
12. Those who participate or are willing to participate clinical trials of other food products, drugs, or beauty products.
13. Those who have claustrophobia
14. Those who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical examination and treatment management family chief director
Zip code
Address The 5th floor of Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
TEL 03-3452-3381
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales Department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Food Science Research Laboratories, Meiji Co., Ltd.
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
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 品川シーズンテラス健診クリニック/Shinagawa Season Terrace Health Care Clinic

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/29520158
Number of participants that the trial has enrolled
Results
A-mix supplementation in combination with physical activity promotion facilitated abdominal fat reduction in 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
2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 13 Day
Last follow-up date
2017 Year 05 Month 21 Day
Date of closure to data entry
2017 Year 07 Month 30 Day
Date trial data considered complete
2017 Year 08 Month 31 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information Diabetes Metab Syndr Obes. 2018 Feb 26;11:23-33. doi: 10.2147/DMSO.S153151.

Management information
Registered date
2016 Year 12 Month 08 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=R000028965

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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