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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040170
Receipt No. R000045797
Scientific Title Clinical study on the combined effects of the natural food of Burock Extract and Aqua Exercise in elderly
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/20

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Basic information
Public title Clinical study on the combined effect of Burdock Extract and Aqua Exercise in humans
Acronym BE: Burdock Extract
AE: Aqua Exercise
Scientific Title Clinical study on the combined effects of the natural food of Burock Extract and Aqua Exercise in elderly
Scientific Title:Acronym BE: Burdock Extract
AE: Aqua Exercise
Region
Asia(except Japan)

Condition
Condition a randomized, double-blind controlled trial
Classification by specialty
Endocrinology and Metabolism Laboratory medicine Blood transfusion
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the impact of AE and BE, individually or in combination, on body composition and sex-related hormone levels in elderly women with Metabolic Syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Our findings suggested that the combined AE/BE intervention had no synergistic and/or additive effects on any sex-related outcome measures in elderly women with Metabolic Syndrome.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food Other
Interventions/Control_1 Control: 16-week experiment
Interventions/Control_2 Burdock Extract: the participants consumed one 100-mL dose of BE, 3 times a day, after each meal (breakfast, lunch, and dinner), for a total of 300 mL of BE per day for 16-week.
Interventions/Control_3 Aqua Exercise: Aqua exercise was performed three times per week for 16-week at a swimming pool.
Interventions/Control_4 Burdock Extract and Aqua Exercise: It was conducted in the same way as independent treatment.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
67 years-old <=
Age-upper limit
84 years-old >=
Gender Female
Key inclusion criteria Participants did not have any diseases that could affect the experiment, and those who voluntarily participated were selected by fully understanding the purpose and purpose of the study.
Key exclusion criteria Participants did not practice regular physical activity and had no history of hormone replacement therapy, drug or alcohol abuse, smoking, allergies, chronic diseases, thyroid disease, eating disorders, consumption of any supplement, or atherosclerotic cardiovascular disease.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Min-Seong
Middle name
Last name Ha
Organization University of Tsukuba
Division name Division of Sports Neuroscience, Advanced Research Initiative for Human High Performance (ARIHHP), Faculty of Health and Sport Sciences
Zip code 305-8574
Address A209, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8574, Japan
TEL 080-3347-1142
Email ha.minseong.fn@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Min-Seong
Middle name
Last name Ha
Organization University of Tsukuba
Division name Division of Sports Neuroscience, Advanced Research Initiative for Human High Performance (ARIHHP), F
Zip code 305-8574
Address A209, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8574, Japan
TEL 080-3347-1142
Homepage URL
Email ha.minseong.fn@u.tsukuba.ac.jp

Sponsor
Institute Pusan National University, Republic of Korea
Institute
Department

Funding Source
Organization This research received no external funding.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Tsukuba
Address A209, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8574, Japan
Tel 080-3347-1142
Email ha.minseong.fn@u.tsukuba.ac.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
2020 Year 05 Month 20 Day

Related information
URL releasing protocol Not published yet.
Publication of results Unpublished

Result
URL related to results and publications Not published yet.
Number of participants that the trial has enrolled 24
Results
The percentage of abdominal fat was decreased in the AE group. Waist circumference was increased in the CON group, but not in the other groups. SHBG and estradiol were enhanced by both AE and BE, and correlated with changes in fat-related body composition. DHEA-S only increased in the BE group, consistently with changes in lean body mass. Testosterone was decreased in the CON group, which correlated with changes in lean body mass, skeletal muscle mass, body fat, and waist circumference.
Results date posted
2020 Year 04 Month 15 Day
Results Delayed
Delay expected
Results Delay Reason Not published yet
Date of the first journal publication of results
Baseline Characteristics
Thirty-two elderly women volunteers with Metabolic Syndrome from South Korea were initially enrolled (average age: 74.31).
Participant flow
Twenty-four subjects (average age: 75.25) were finally selected for the 16-week experiment: (1) control group (CON: n = 7), (2) aquatic exercise group (AE: n = 6), (3) burdock root extract ingestion group (BE: n = 5), and (4) combination of aquatic exercise and burdock root extract ingestion group (AE+BE: n = 6). 
Adverse events
None
Outcome measures
The following parameters were tested before and after the 16-week intervention: body composition and circulating hormones.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 03 Day
Date of IRB
2015 Year 01 Month 05 Day
Anticipated trial start date
2015 Year 01 Month 10 Day
Last follow-up date
2015 Year 04 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 15 Day
Last modified on
2020 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045797

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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