Unique ID issued by UMIN | UMIN000044936 |
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Receipt number | R000051319 |
Scientific Title | A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study- |
Date of disclosure of the study information | 2021/07/21 |
Last modified on | 2021/07/21 16:23:17 |
A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study-
A study to evaluate the effects of functional food on body fat mass
A study to evaluate the effects of functional food on body fat mass -Randomized, placebo-controlled, double-blind, parallel group comparison study-
A study to evaluate the effects of functional food on body fat mass
Japan |
None
Not applicable | Adult |
Others
NO
To investigate safety and efficacy of intake of the test food for 12 weeks on body fat mass in in healthy adults classified as pre-obese or obese class I
Safety,Efficacy
Abdominal visceral fat area
Body weight, BMI, body fat percentage, abdominal total fat area, abdominal subcutaneous fat area, body composition (In Body), circumference, questionnaire survey
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Intake 5 tablets of the test food for 12 weeks
Intake 5 tablets of the placebo food for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
1) Males and females aged of 20-64 years at the date of informed consent
2) Subjects whose BMI 24 kg/m2 or more and less than 30 kg/m2
3) Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study
1)Subjects who use pharmaceuticals affecting the study
2)Subjects who have a history of severe kidney disease, heart disease, respiratory disease, endocrine disease, diabetes, etc., and undergoing treatment for them (excluding transient treatment such as colds)
3)Subjects who cannot stop taking supplements and health foods (including foods for specified health use and foods with functional claims) that may affect something for the test in the study period
4)Subjects who declare some allergies to the components of the test food
5)Subjects who have a history of drug/alcohol dependence or a current medical history
6)Subjects who have metal by surgery and others in measurement areas for CT scan
7)Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators
8)Claustrophobic
9)Subjects who are currently pregnant or lactating, or who plan to become pregnant in the study period
10)Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past month from the date of consent, or who plan to participate in others
11)Subjects judged as unsuitable for this study by the principal investigator
80
1st name | Toru |
Middle name | |
Last name | Sagami |
Shinagawa Season Terrace Health Care Clinic
Doctor
108-0075
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
03-3452-3382
shibaura@sempos.or.jp
1st name | Eiji |
Middle name | |
Last name | Yoshikawa |
KSO Corporation
Sales department
108-0023
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
03-3452-7733
yoshikawa@kso.co.jp
KSO Corporation
NatureLab.Co.,Ltd.
Profit organization
Ethical Committee of Kobuna Orthopedics Clinic
311-2, Gokammachi, Maebashi Shi, Gumma Ken, 371-0813, Japan
027-212-5608
sagawa@mc-connect.co.jp
NO
一般財団法人船員保険会 品川シーズンテラス健診クリニック(東京都)
2021 | Year | 07 | Month | 21 | Day |
Unpublished
Preinitiation
2021 | Year | 05 | Month | 11 | Day |
2021 | Year | 05 | Month | 13 | Day |
2021 | Year | 07 | Month | 10 | Day |
2021 | Year | 12 | Month | 12 | Day |
2021 | Year | 07 | Month | 21 | Day |
2021 | Year | 07 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051319
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