Unique ID issued by UMIN | UMIN000016239 |
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Receipt number | R000018845 |
Scientific Title | Body fat-reducing effect of tablets containing lactoferrin and cacao extract: A randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2015/01/16 |
Last modified on | 2017/03/27 18:15:22 |
Body fat-reducing effect of tablets containing lactoferrin and cacao extract: A randomized, double-blind, placebo-controlled, parallel-group study
Body fat-reducing effect of tablets containing lactoferrin and cacao extract
Body fat-reducing effect of tablets containing lactoferrin and cacao extract: A randomized, double-blind, placebo-controlled, parallel-group study
Body fat-reducing effect of tablets containing lactoferrin and cacao extract
Japan |
No (healthy adults or slightly overweight subjects)
Not applicable |
Others
NO
We conducted a randomized controlled trial to examine the body fat, including visceral fat, reducing effect of tablets containing lactoferrin and cacao extract in healthy adults or overweight subjects.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1) Visceral fat area
2) Total fat area
3) Subcutaneous fat area
measured before and 12 weeks after ingestion of the tablets.
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Ingestion of 4 tablets containing lactoferrin and cacao extract once a day for 12 weeks
Ingestion of 4 tablets not containing lactoferrin and cacao extract once a day for 12 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
(1) Males and females aged 20 to 64 years old.
(2) Subjects have three square meals a day.
(3) Subjects whose BMI are 23 to 24.9 or 25 to 29.9.
(4) Subjects with visceral fat areas of more than 80 cm2 (on CT analysis) at the screening test.
(5) Subjects giving written informed consent.
(1) Subjects who use medications affecting obesity, hyperlipidemia, lipid metabolism, and so on.
(2) Subjects who can't stop using supplements and/or functional foods affecting obesity, hyperlipidemia, lipid metabolism, and so on.
(3) Subjects who are pregnant or lactating.
(4) Subjects who have under treatment or a history of drug addiction and/or alcoholism.
(5) Subjects who are planned to participate in other clinical study.
(6) Subjects who are judged as unsuitable for the study by the investigator for the other reason.
60
1st name | |
Middle name | |
Last name | Naoya Sekiguchi |
Sekiguchi Clinic
Director
5-17-27 Nekozane, Urayasu-shi, Chiba
047-306-3557
scfira@royal.ocn.ne.jp
1st name | |
Middle name | |
Last name | Yoshika Komori |
KSO Corporation
Sales department
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
yoshi@kso.co.jp
KSO Corporation
LION Corporation
Profit organization
NO
せきぐちクリニック(千葉県)
2015 | Year | 01 | Month | 16 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 28 | Day |
2015 | Year | 01 | Month | 18 | Day |
2015 | Year | 01 | Month | 16 | Day |
2017 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018845
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