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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000040170
受付番号 R000045797
科学的試験名
一般公開日(本登録希望日) 2020/05/20
最終更新日 2020/05/20

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title
Clinical study on the combined effect of Burdock Extract and Aqua Exercise in humans
一般向け試験名略称/Acronym
BE: Burdock Extract
AE: Aqua Exercise
科学的試験名/Scientific Title
Clinical study on the combined effects of the natural food of Burock Extract and Aqua Exercise in elderly
科学的試験名略称/Scientific Title:Acronym
BE: Burdock Extract
AE: Aqua Exercise
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
a randomized, double-blind controlled trial
疾患区分1/Classification by specialty
内分泌・代謝病内科学/Endocrinology and Metabolism 検査医学/Laboratory medicine
輸血医学/Blood transfusion 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/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.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 4
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
食品/Food その他/Other
介入1/Interventions/Control_1
Control: 16-week experiment
介入2/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.
介入3/Interventions/Control_3
Aqua Exercise: Aqua exercise was performed three times per week for 16-week at a swimming pool.
介入4/Interventions/Control_4
Burdock Extract and Aqua Exercise: It was conducted in the same way as independent treatment.
介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
67 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
84 歳/years-old 以下/>=
性別/Gender 女/Female
選択基準/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.
除外基準/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.
目標参加者数/Target sample size 32

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Min-Seong
ミドルネーム
Ha
所属組織/Organization
University of Tsukuba
所属部署/Division name
Division of Sports Neuroscience, Advanced Research Initiative for Human High Performance (ARIHHP), Faculty of Health and Sport Sciences
郵便番号/Zip code 305-8574
住所/Address
A209, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8574, Japan
電話/TEL 080-3347-1142
Email/Email ha.minseong.fn@u.tsukuba.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Min-Seong
ミドルネーム
Ha
組織名/Organization
University of Tsukuba
部署名/Division name
Division of Sports Neuroscience, Advanced Research Initiative for Human High Performance (ARIHHP), F
郵便番号/Zip code 305-8574
住所/Address
A209, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8574, Japan
電話/TEL 080-3347-1142
試験のホームページURL/Homepage URL
Email/Email ha.minseong.fn@u.tsukuba.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Pusan National University, Republic of Korea
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 This research received no external funding.
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
None
その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
University of Tsukuba
住所/Address
A209, 1-1-1 Tennoudai, Tsukuba, Ibaraki 305-8574, Japan
電話/Tel 080-3347-1142
Email/Email ha.minseong.fn@u.tsukuba.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 05 20

関連情報/Related information
プロトコル掲載URL/URL releasing protocol Not published yet.
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications Not published yet.
組み入れ参加者数/Number of participants that the trial has enrolled 24
主な結果/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.
主な結果入力日/Results date posted
2020 04 15
結果掲載遅延/Results Delayed
遅れる予定/Delay expected
結果遅延理由/Results Delay Reason
Not published yet
最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics
Thirty-two elderly women volunteers with Metabolic Syndrome from South Korea were initially enrolled (average age: 74.31).
参加者の流れ/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).
有害事象/Adverse events
None
評価項目/Outcome measures
The following parameters were tested before and after the 16-week intervention: body composition and circulating hormones.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2014 10 03
倫理委員会による承認日/Date of IRB
2015 01 05
登録・組入れ開始(予定)日/Anticipated trial start date
2015 01 10
フォロー終了(予定)日/Last follow-up date
2015 04 15
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 04 15
最終更新日/Last modified on
2020 05 20


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045797
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045797

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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