UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040109
Receipt number 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 2021/10/12 11:31:29

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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 or person

Institute

Hokkaido Information University

Institute

Department

Personal name



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

Value
https://center6.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