Unique ID issued by UMIN | UMIN000005622 |
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Receipt number | R000006374 |
Scientific Title | A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE |
Date of disclosure of the study information | 2011/05/20 |
Last modified on | 2012/10/30 11:00:52 |
A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE
A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED CHOCOLATE
A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE
A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED CHOCOLATE
Japan |
hypercholestemia
Endocrinology and Metabolism |
Others
NO
To evaluate the effect on cholesterol reduction and the safety under the consumption of a plant sterol-enriched chocolate for 12 weeks
Safety,Efficacy
Bloodchemisty, hematology and physical examination at 4-week, 8-week, 12-week consumption and 4-week after consumption period
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Effectiveness and safety after 12 weeks of
test food consumption compared to before
comsumption
Effectiveness and safety of 12-week test
food consumption compared to placebo control
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) Subject with total cholesterol serum level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160
mg/dL
2) Subject, aged from 20 to 65 years (bounds included)
3) Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent
1) Subject taking any hypocholesterolemic
treatment
2) Subfect currently involved in other clinical trial
3) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study
4) For female subject: pregnancy or possibility of pregnancy, or intention to be pregnant during the study
5) For female subject: breast feeding
6) Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products
7) Subject having sitosterolemia
8) Subject receiving treatment for serious
liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders
9) Subject deemed unsuitable by the investigator
80
1st name | |
Middle name | |
Last name | Yoshitaka Kajimoto |
Senrichuo Ekimae Clinic
Director
Senri Life Science Center 3F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka.
1st name | |
Middle name | |
Last name |
Soiken Inc.
Department of Clinical Evaluation System
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka.
06-6871-8888
Soiken Inc.
Soiken Inc.
Profit organization
NO
2011 | Year | 05 | Month | 20 | Day |
Unpublished
Completed
2010 | Year | 12 | Month | 17 | Day |
2011 | Year | 01 | Month | 01 | Day |
2011 | Year | 05 | Month | 20 | Day |
2012 | Year | 10 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006374
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