UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035980 |
|---|---|
| Receipt number | R000040982 |
| Scientific Title | The effects of combination of maslinic acid supplementation and physical exercise on body composition: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2019/03/05 |
| Last modified on | 2020/02/23 09:33:58 |
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Basic information
Public title
The effects of combination of maslinic acid supplementation and physical exercise on body composition: a randomized, double-blind, placebo-controlled trial
Acronym
Maslinic acid and daily exercise trial
Scientific Title
The effects of combination of maslinic acid supplementation and physical exercise on body composition: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
Maslinic acid and daily exercise trial
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of combination of maslinic acid (olive fruit extract) intake and daily physical exercise on body composition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass (baseline, after 6 weeks, after 12 weeks)
Key secondary outcomes
body weight, body mass index, body composition, one leg standing time with open eyes, 10-meters walking speed, 10-meters walking speed with obstruction, handgrip strength, isometric knee extension strength, QOL(SF-8), JKOM scores
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The participants consume capusules including 30 mg maslinic acid per day after breakfast for 12 weeks. In addition, they practice the programmed strength training during the trial everyday.
Interventions/Control_2
The participants consume capusules including 60 mg maslinic acid per day after breakfast for 12 weeks. In addition, they practice the programmed strength training during the trial everyday.
Interventions/Control_3
The participants consume placebo capusules per day after breakfast for 12 weeks. In addition, they practice the programmed strength training during the trial everyday.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 40 years of age or older
(2) can practice daily exercise (resistance training and walking)
(3) can agree to participate by their own will and provide written informed consent before entry.
Key exclusion criteria
(1) having allergy against olive
(2) pregnancy, and engagement in breast-feeding
(3) undergoing rehabilitation by knee or waist pain
(4) have participated another clinical trial within 3 month befer agreement
(5) judged inadequate for participation by the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
791-0243
Address
1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL
089-904-7811
tetsu@shin-science.co.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Institute of Social Epidemiology
Zip code
791-0243
Address
1383-2 Hiraimachi, Matsuyama-city, Ehime
TEL
089-904-7811
Homepage URL
tetsu@shin-science.co.jp
Sponsor or person
Institute
Institute of Community Life Sciences Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIPPON FLOUR MILLS CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Borad, Sapporo Urinokai Hospital
Address
11-186, Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.jp
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
| 2019 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
69
Results
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
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 22 | Day |
Last modified on
| 2020 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040982
