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

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 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


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

Value
https://center6.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