UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033084
Receipt number R000037726
Scientific Title An investigation on the visceral fat reduction effect and the safety of coffee.
Date of disclosure of the study information 2018/06/21
Last modified on 2021/05/19 21:59:01

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Basic information

Public title

An investigation on the visceral fat reduction effect and the safety of coffee.

Acronym

An investigation on the visceral fat reduction effect and the safety of coffee.

Scientific Title

An investigation on the visceral fat reduction effect and the safety of coffee.

Scientific Title:Acronym

An investigation on the visceral fat reduction effect and the safety of coffee.

Region

Japan


Condition

Condition

N/A(People with a BMI of at least 25 kg/m2 and less than 30kg/m2.)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the visceral fat reduction effect and the safety of continuous consumption of coffee for a period of 12 weeks, using adult men and women with a BMI of at least 25 kg/m2 and less than 30kg/m2.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Visceral Fat
Measured at initial, 4 week, 8 week, and 12 week visits

Key secondary outcomes

Weight
Measured at initial, 4 week, 8 week, and 12 week visits

BMI
Measured at initial, 4 week, 8 week, and 12 week visits

Waist Circumference
Measured at initial, 4 week, 8 week, and 12 week visits


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Placebo (30 patients)
Coffee.
Consumption period of 12 weeks. 1 drink per day.

Interventions/Control_2

Intervention (30 patients)
Coffee.
Consumption period of 12 weeks. 1 drink per day.

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Adults (men and women) who are at least 20 and under 65 years of age when Informed Consent is taken
2. People with a BMI of at least 25 kg/m2 and less than 30 kg/m2
3. People who voluntary give written informed consent to participate in the study before study begins

Key exclusion criteria

1. People who have very irregular dietary habits
2. People on continuous treatment with medication
3. People with medicine or food allergies
4. People using medicine, foods for specified health uses, foods with functional claims, supplements, or diet products that may have an effect on the study
5. People with hypertension , diabetes mellitus, dyslipidemia ,or other lifestyle-related diseases
6. People with gastrointestinal dysfunction, significant liver dysfunction, significant kidney dysfunction, or significant cardiovascular disease
7. People with a history of a gastrectomy/extensive digestive tract excision
8. People with dependence on drugs or alcohol
9. People who are pregnant, nursing, or plan to become pregnant
10. Other people determined to be unsuitable for participation in the study by the principal investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tsuguyoshi
Middle name
Last name Asano

Organization

Asano Kanamachi Clinic

Division name

Director

Zip code

125-0041

Address

1-18-3, Higashikanamachi, Katsushika-ku, Tokyo, Japan Postal Code: 125-0041

TEL

03-3609-7511

Email

dr-asano@syd.odn.ne.jp


Public contact

Name of contact person

1st name Kazuo
Middle name
Last name Haruna

Organization

Increase Co., Ltd.

Division name

Clinical Development Department

Zip code

103-0002

Address

1-5-6, Nihonbashi Bakuro-cho, Chuo-ku, Tokyo Imasu Office Bakurocho Bldg 8F Postal Code: 103-0002

TEL

03-6231-1394

Homepage URL


Email

key001@inc-cro.co.jp


Sponsor or person

Institute

Tsuguyoshi Asano

Institute

Department

Personal name



Funding Source

Organization

Key Coffee Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Allergies

Address

1-8-6 Kuramae Taito-ku, Tokyo

Tel

03-6264-9792

Email

hayashi_sayaka@mdv.co.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

あさの金町クリニック(東京都)、ふたばクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 21 Day


Related information

URL releasing protocol

http://lifescience.co.jp/yk/

Publication of results

Published


Result

URL related to results and publications

http://lifescience.co.jp/yk/

Number of participants that the trial has enrolled

62

Results

In the blood and urine examination, blood pressure, heart rate and subjective symptom did not show adverse effects.
In conclusion,compared with control coffee, the chlorogenic acids-enriched coffee was significantly effective and safe to decrease visceral fat and serum triglyceride.

Results date posted

2021 Year 05 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects included patients attending the two participating facilities and volunteers with metabolic syndrome concerns, for a total of 62 subjects.

Participant flow

Forty-eight protocol-compliant subjects were included in the analysis, excluding 14 subjects with personal reasons, transfer, poor intake or difficulty in regular intake, dietary irregularities, or inadequate BMI among 62 subjects.

Adverse events

There were no significant changes in blood pressure, pulse rate, or physical examination, and no subjective symptoms of illness or gastrointestinal dysfunction were observed. No adverse events were observed in the follow-up survey.

Outcome measures

A comparison test of the amount and rate of change of visceral fat within and between the control and test food groups was conducted at 4, 8, and 12 weeks. In the within-group comparison, there was a significant decrease in the test food group at 4 and 12 weeks in both the amount and rate of change (Table 3). In the between-group comparison, there was a significant difference in the amount and rate of change at 4 and 12 weeks.

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 01 Month 25 Day

Anticipated trial start date

2018 Year 06 Month 25 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 21 Day

Last modified on

2021 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037726


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name