UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025186 |
|---|---|
| Receipt number | 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 09:21:14 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028965
