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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035980
Receipt No. 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 2019/09/15

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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
Email 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
Email tetsu@shin-science.co.jp

Sponsor
Institute Institute of Community Life Sciences Co., Ltd.
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040982

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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