UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040170 |
|---|---|
| Receipt number | 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 09:13:55 |
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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
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
ha.minseong.fn@u.tsukuba.ac.jp
Sponsor or person
Institute
Pusan National University, Republic of Korea
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045797
