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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000003779 |
Receipt No. | R000004575 |
Scientific Title | A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK - Effectiveness and Long-term Safety Study - |
Date of disclosure of the study information | 2010/06/18 |
Last modified on | 2010/12/20 |
Basic information | ||
Public title | A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study - |
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Acronym | A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study - |
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Scientific Title | A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study - |
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Scientific Title:Acronym | A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Effectiveness and Long-term Safety Study - |
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Region |
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Condition | ||
Condition | hypercholestemia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | To evaluate the effect on cholesterol reduction and the safety under the consumption of yoghurt drink enriched with plant sterols for 12 weeks |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Bloodchemisty, hematology and physical examination after 4-week, 8-week and 12-week consumption |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Effectiveness and safety after 12 weeks of test food consumption compared to before consumption | |
Interventions/Control_2 | Effectiveness and safety of 12-week test food consumption compared to placebo control | |
Interventions/Control_3 | Effectiveness and safety of 12-week high-dose test food consumption compared to low-dose test food consumption | |
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Subject with total cholesterol plasma 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 with BMI between 19 - 30 kg/m2; (bounds included) 4) Subject with triglycerides under 400 mg/dL 5) Non diabetic subjects (BS<=125 mg/dL) 6) Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg) 7) Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subjects (according to Japan Atherosclerosis Society guidelines) 8) Subject agreeing not to consume any supplements/excessive plant sterols in any form during the study priod (from initial to final visit) 9) 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. |
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Key exclusion criteria | 1) Subject currently involved in other clinical trial.
2) Subject taking any hypocholesterolemic treatment (statins, ezetimibe, niacin, omega-3 FA, 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 prior to the start of the present study. 4) For female subject: 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 lactose intolerance. 8) Subject having sitosterolemia 9) Diabetic subject (Type I and type II) 10) Subject with heavy alcohol intake (>60 g/day) 11) Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 12) Subject receiving a transplant or under immunosuppressor treatment 13) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 14) Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angor pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months 15) Subject deemed unsuitable by the investigator. |
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Target sample size | 117 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Senrichuo Ekimae Clinic | ||||||
Division name | Director | ||||||
Zip code | |||||||
Address | Senri Life Science Center 3F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | Soiken Inc. | ||||||
Division name | Department of Clinical Evaluation System | ||||||
Zip code | |||||||
Address | Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka | ||||||
TEL | 06-6871-8888 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | Soiken Inc. |
Institute | |
Department |
Funding Source | |
Organization | Soiken Inc. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004575 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |