UMIN-CTR Clinical Trial
| 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 (Ver. 3) |
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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 |
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| 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 |
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| Condition | |||||
| Condition | a randomized, double-blind controlled trial | ||||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| 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 |
| 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 | |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| Results Delayed |
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| 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). |
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| 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). |
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| Adverse events | None |
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| Outcome measures | The following parameters were tested before and after the 16-week intervention: body composition and circulating hormones. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045797 |
