UMIN-CTR Clinical Trial

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	https://www.nature.com/articles/s41598-021-98612-6
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	Main results already published
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	2021 Year 10 Month 12 Day

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