Unique ID issued by UMIN | UMIN000033084 |
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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 |
An investigation on the visceral fat reduction effect and the safety of coffee.
An investigation on the visceral fat reduction effect and the safety of coffee.
An investigation on the visceral fat reduction effect and the safety of coffee.
An investigation on the visceral fat reduction effect and the safety of coffee.
Japan |
N/A(People with a BMI of at least 25 kg/m2 and less than 30kg/m2.)
Adult |
Others
NO
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.
Safety,Efficacy
Confirmatory
Not applicable
Visceral Fat
Measured at initial, 4 week, 8 week, and 12 week visits
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Placebo (30 patients)
Coffee.
Consumption period of 12 weeks. 1 drink per day.
Intervention (30 patients)
Coffee.
Consumption period of 12 weeks. 1 drink per day.
20 | years-old | <= |
65 | years-old | > |
Male and Female
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
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
60
1st name | Tsuguyoshi |
Middle name | |
Last name | Asano |
Asano Kanamachi Clinic
Director
125-0041
1-18-3, Higashikanamachi, Katsushika-ku, Tokyo, Japan Postal Code: 125-0041
03-3609-7511
dr-asano@syd.odn.ne.jp
1st name | Kazuo |
Middle name | |
Last name | Haruna |
Increase Co., Ltd.
Clinical Development Department
103-0002
1-5-6, Nihonbashi Bakuro-cho, Chuo-ku, Tokyo Imasu Office Bakurocho Bldg 8F Postal Code: 103-0002
03-6231-1394
key001@inc-cro.co.jp
Tsuguyoshi Asano
Key Coffee Inc.
Profit organization
Japan
Tokyo Allergies
1-8-6 Kuramae Taito-ku, Tokyo
03-6264-9792
hayashi_sayaka@mdv.co.jp
NO
あさの金町クリニック(東京都)、ふたばクリニック(東京都)
2018 | Year | 06 | Month | 21 | Day |
http://lifescience.co.jp/yk/
Published
http://lifescience.co.jp/yk/
62
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.
2021 | Year | 05 | Month | 19 | Day |
The subjects included patients attending the two participating facilities and volunteers with metabolic syndrome concerns, for a total of 62 subjects.
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.
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.
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.
Completed
2018 | Year | 05 | Month | 25 | Day |
2018 | Year | 01 | Month | 25 | Day |
2018 | Year | 06 | Month | 25 | Day |
2019 | Year | 02 | Month | 28 | Day |
2018 | Year | 06 | Month | 21 | Day |
2021 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037726
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