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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040109
Receipt No. R000045732
Scientific Title Effect of Daily Ingestion of tea containing citrus ingredients on abdominal visceral fat area reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Date of disclosure of the study information 2020/04/08
Last modified on 2020/06/23

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Basic information
Public title Effect of Daily Ingestion of tea containing citrus ingredients on abdominal visceral fat area reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym Effect of Daily Ingestion of tea containing citrus ingredients on abdominal visceral fat area reduction
Scientific Title Effect of Daily Ingestion of tea containing citrus ingredients on abdominal visceral fat area reduction: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym Effect of Daily Ingestion of tea containing citrus ingredients on abdominal visceral fat area reduction
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove clinical benefits associated with 12 weeks daily ingestion of tea containing citrus ingredients on abdominal visceral fat area reduction, in a randomized, double-blind, placebo-controlled, parallel group comparison study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Change in the visceral fat area after 12 weeks of ingestion.
Key secondary outcomes Abdominal subcutaneous fat area, abdominal total fat area, TC, LDL-C, HDL-C, TG, LDL/HDL, body weight, body fat percentage, BMI, lean body mass, muscle mass, blood cGMP, prothrombin time, cytokine, grip strength, leg strength.

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily ingestion of 13.6 g instant green tea for 12 weeks.
Interventions/Control_2 Daily ingestion of 13.6 g instant barley tea 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
30 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects whose LDL-C is more than 100 mg/dl and less than 140 mg/dl.
2. Subjects whose BMI is more than 23 kg/m 2 and less than 30 kg/m 2 .
3. Subjects who agree to participate in this study with a written informed consent.
Key exclusion criteria 1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes.
2. Pacemaker or defibrillator users.
3. Subject who disagree to cooperate with grip strength test and leg strength test at the time of screening test.
4. Subjects with familial hypercholesterolemia.
5. Subjects whose fasting blood glucose values are more than 126 mg/dl.
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 physical data and hematological data.
9. Subjects with severe anemia.
10. Pre- or post-menopausal women complaining of obvious physical changes.
11. Subjects s who regularly drink green tea.
12. Subjects who has high caffeine sensitivity.Subjects who are at risk of having allergic reactions to drugs or foods.
13. Subjects who has high caffeine sensitivity.
14. Subjects who regularly take medicine, functional foods, and/or supplements which would affect lipid metabolism.
15. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism.
16. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
17. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks, or blood components within 2 weeks, prior to the current study.
18. Pregnant or lactating women or women who expect to be pregnant during this study.
19. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
20. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 60

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
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 Toyota Motor Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Bioresource and Bioenvironment Kyushu University
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
2020 Year 04 Month 08 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 60
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 No longer recruiting
Date of protocol fixation
2020 Year 01 Month 22 Day
Date of IRB
2020 Year 01 Month 22 Day
Anticipated trial start date
2020 Year 06 Month 24 Day
Last follow-up date
2020 Year 10 Month 17 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 08 Day
Last modified on
2020 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045732

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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