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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033410
Receipt No. R000038093
Scientific Title Effect of Daily Ingestion of Quercetin-Rich Onion on Visceral Fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2018/07/17
Last modified on 2019/08/05

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Basic information
Public title Effect of Daily Ingestion of Quercetin-Rich Onion on Visceral Fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym Beneficial Effects of Quercetin-Rich Onion on Visceral Fat
Scientific Title Effect of Daily Ingestion of Quercetin-Rich Onion on Visceral Fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym Beneficial Effects of Quercetin-Rich Onion on Visceral Fat
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate clinical benefits associated with 12 week daily ingestion of the processed food of quercetin-rich onion on visceral fat in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Visceral fat area at 12 weeks after beginning the ingestion of test food.
Key secondary outcomes total fat area, subcutaneous fat area, body weight, body mass index, body fat rate, abdominal circumference, hospital blood pressure, home blood pressure, TBARS, serum quercetin

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 NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily ingestion 9 g of quercetin-rich onion powder for 12 weeks.
Interventions/Control_2 Daily ingestion 9 g of quercetin-free onion powder for 12 weeks.
Interventions/Control_3
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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. Subjects whose BMI is >=23 kg/m2 and <30 kg/m2.
Key exclusion criteria 1.Subjects who are under physician's advice, treatment, and/or medication for obese, and/or hypertension.
2.Subjects who suspected obesity.
3.Pacemaker or defibrillator users.
4.Subjects whose hospital systolic blood pressure is >=160 mmHg and/or hospital diastolic blood pressure is >=100 mmHg.
5.Subjects who have (or suspected) secondary hypertension such as renovascular hypertension, renal parenchymal hypertension, primary aldosteronism, Cushing's syndrome, hypothyroidism, hyperthyroidism, etc.
6.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
7.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
8.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
9.Subjects with severe anemia.
10.Pre- or post-menopausal women complaining of obvious physical changes.
11.Subjects who are at risk of having allergic reactions to drugs or foods especially based on onion.
12.Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFR.
13.Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood pressure.
14.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
15.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
16.Pregnant or lactating women or women who expect to be pregnant during this study.
17.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
18.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name NISHIHIRA
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code 069-8585
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization NARO Bio-oriented Technology Research Advancement Institution
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1. Food Research Institute, NARO
2. Hokkaido Agricultural Research Center, NARO
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committee of Hokkaido Information University
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel 011-385-4411
Email soumu@do-johodai.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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 17 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 70
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 Completed
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
2018 Year 05 Month 25 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2018 Year 12 Month 20 Day
Date of closure to data entry
2019 Year 02 Month 26 Day
Date trial data considered complete
2019 Year 03 Month 05 Day
Date analysis concluded
2019 Year 03 Month 29 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 17 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038093

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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