Unique ID issued by UMIN | UMIN000003449 |
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Receipt number | R000004173 |
Scientific Title | A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK |
Date of disclosure of the study information | 2010/04/17 |
Last modified on | 2014/04/05 15:01:36 |
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK
Japan |
hypercholestemia
Endocrinology and Metabolism |
Others
NO
To investigate the safety of excessive consumption of a yoghurt drink enriched with plant sterols for 4 weeks
Safety
Bloodchemistry, hematology and physical examination after 2-week and 4-week consumption
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Safety of 4-week excessive consumption compared to before consumption
Safety of 4-week excessive consumption compared to placebo control
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1)Subject with total cholesterol plasma level of under 240 mg/dL (6.2 mmg/dL) (with half of the subjects at entry under 200 mg/dL or 5.2 mmol/L)
2)Subject with LDL-cholesterol plasma level of under 160 mg/dL (4.1 mmol/L) (with half of the subjects at entry under 120 mg/dL or 3.1 mmol/L)
3)Subject, aged from 20 to 65 years (bounds included)
4)Subject, BMI from 19 to 30 kg/m2 (bounds included)
5)Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
6)Non diabetic subjects (FBS≤125 mg/dL)
7)Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg)
8)Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subjects (according to Japan Atherosclerosis Society guidelines)
9)Subject agreeing not to consume any supplements/excessive plant sterols in any form during the study period (from initial to final visit)
10)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 currently involved in a clinical trial.
2)Subject taking any hypocholesterolemic treatment drugs (statins,ezetimibe, niacin, omega-3 fatty acids, fibrates)
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 of 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)Subjects having lactose intorelance
8) Subjects having sitosterolemia
9)Diabetic subject (Type I and type II)
10)Subject having lactose intolerance.
11)Subject with heavy alcohol intake (> 60g/day)
12)Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
13)Subject receiving a transplant or under immunosuppressor treatment
14)Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
15)Subject deemed unsuitable by the investigator.
40
1st name | |
Middle name | |
Last name | Yoshitaka Kajimoto |
Senrichuo Ekimae Clinic
Director
Senri Life Science Center 3F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6318-5745
kajimoto@senri-cl.com
1st name | |
Middle name | |
Last name | Tomohiro Sugino |
Soiken Inc.
Department of Clinical Evaluation System
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
06-6871-8888
sugino@soiken.com
Soiken Inc.
Soiken Inc.
Profit organization
NO
2010 | Year | 04 | Month | 17 | Day |
Unpublished
Completed
2009 | Year | 12 | Month | 19 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 04 | Month | 05 | Day |
2014 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004173
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