NCT02268318已完成不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY TO EVALUATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT STEROL-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH HIGH LDL-C
Danone Japan2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Evolution of LDL-cholesterol concentration after 6 weeks of product consumption, expressed as a relative change from baseline.
研究概览
简要总结
INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH HIGH LDL-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An individual must fulfil all of the following criteria in order to be eligible for trial enrolment
- •To be checked at the inclusion visit (V1):
- •II 01: Male/female subject, aged from 20 to 75 years (bounds included).
- •II 02: Subject with body mass index (BMI) between 18.5 kg/m2 (bound included) and 30 kg/m2 (bound excluded).
- •II 03: Subject with LDL-cholesterol blood level between 120 mg/dL (3.1 mmol/L) and 160 mg/dL (4.14 mmol/L) (bounds included).
- •II 04: Subject with triglycerides under 200 mg/dL (2.3 mmol/L).
- •II 05: Non hypertensive subject defined with Systolic Blood Pressure (SBP) <140 mmHg and Diastolic Blood Pressure (DBP) <90 mmHg OR subject with treated and controlled hypertension defined with SBP <140 mmHg and DBP <90 mmHg since at least 1 month.
- •II 06: Subject who already received the dietary recommendations advisable for hyper or borderline hyper-LDL cholesterolemic subjects (according to Japan Atherosclerosis Society guidelines).
- •II 07: Subject agreeing not to consume any supplements/ food products enriched with plant sterols and plant stanols in any form and soy milk product during the study period.
- •II 08: Female subject must be postmenopausal for at least 12 months prior to trial entry or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or bilateral tubal ligation) OR if of child bearing potential, female subject must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively:
- •Oral birth control pills (at least 1 full monthly cycle prior to study product administration);
- •Intra-uterine device (IUD);
- •Double barrier methods (such as condoms and spermicide);
- •Abstinence, when in the opinion of the investigator, their occupation or life style gives efficient evidence that abstinence will be maintained throughout the study and for one month thereafter.
- •II 09: Subject covered by social security or covered by similar system.
- •II 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.
- •II 11: Subject having given written (dated and signed) inform consent to take part in the study.
- •II 12: Asian subjects originating from Japan.
- •II 13: Subject who is able to communicate well with the investigator and to comply with the requirements of the entire study.
- •II 14: Subject having a fridge at home for study products storage with sufficient capacity.
- •To be checked at the randomization visit (V2):
- •RI 01: Subject with LDL-cholesterol blood level between 120 mg/dL (3.1 mmol/L) and 160 mg/dL (4.14 mmol/L) (bounds included).
- •RI 02: Subject with triglycerides under 200 mg/dL (2.3 mmol/L).
- •RI 03: Subject having compliance to the product during the run-in period 80%.
- •RI 04: Subject having followed the dietary recommendations advisable for hypercholesterolaemic patients.
排除标准
- •An individual fulfilling any of the following criteria is to be excluded from trial enrolment
- •To be checked at the inclusion visit (V1):
- •IE 01: Subject under hypocholesterolaemic treatment.
- •IE 02: Subjects having stopped taking their hypocholesterolemic drugs or products (statins, ezetimibe, sequesterants, niacin, nicotinates, probucol, omega-3 fatty acids (EPA-DHA, ALA...), and fibrates) less than 3 months ago.
- •IE 03: Subject with known allergy or hypersensitivity to plant sterols and to any component of the study product (milk protein for example).
- •IE 04: Subjects having sitosterolemia.
- •IE 05: Subject having experienced any cardiovascular event (cardiac infarction, angina attack, surgical or endoscopic coronary angioplasty, stroke, arterial disease, etc.).
- •IE 06: Subject suffering from any serious or chronic liver, renal, cardiovascular, respiratory, endocrine or metabolic disorders.
- •IE 07: Subject with gastro-intestinal disorders (such as diarrhoea, constipation, irritable bowel syndrome) or using laxatives.
- •IE 08: Subject with diabetes Type I and Type II or Fasting Blood Sugar test (FBS) > 125 mg/dL (7.0 mmol/L) at screening visit.
- •IE 09: Subject who had any surgery or intervention requiring a general anesthesia in the preceding 4 weeks, or who plans to have one during the course of the study.
- •IE 10: Subject receiving (currently or in the 4 last weeks) systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
- •IE 11: Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study.
- •IE 12: 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 before the start of the present study.
- •IE 13: Subject with heavy alcohol intake (> 60 g/day).
- •IE 14: Subject taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits (e.g. hypolipemic, hypoglycaemic treatments).
- •IE 15: For female subject: pregnant woman or woman planning to become pregnant during the study; breast-feeding woman.
- •IE 16: For female subject: subject likely to change her contraceptive method or hormone replacement therapy during the study.
- •IE 17: Subject in a situation, which in the investigator's opinion could interfere with optimal participation in the present study (e.g. non-dairy-products consumer) or could constitute a special risk for the subject.
- •IE 18: Subject who is susceptible to not comply with dietary qualitative restriction during the study period.
- •IE 19: Vulnerable subjects defined as individuals whose willingness to volunteer in the clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention.
- •IE 20: Subjects with known lactose intolerance or known allergy to plant sterols.
- •IE 21: Subjects being a heavy soybean milk consumer.
- •IE 22: Subject expected to be living in the same home as a current participating subject and to concomitantly receive some study products.
结局指标
主要结局
Evolution of LDL-cholesterol concentration after 6 weeks of product consumption, expressed as a relative change from baseline.
时间窗: baseline and 6 weeks
次要结局
- - Evolution of LDL-cholesterol concentration after 6 weeks of product consumption, expressed as a raw change from baseline. - Evolution of LDL-cholesterol concentration after 3 and 12 weeks of product consumption, expressed as a relative and raw changes(baseline, 3 / 6 / 12 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Compare Effects of EpiCor and Vitamin C to Vitamin C Alone on the Common Cold or Influenza in Healthy ChildrenSigns and Symptoms, RespiratoryNCT04093206Cargill221
进行中（未招募）
不适用
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDModerate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 18.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 18.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855EUCTR2014-004712-10-GBPearl Therapeutics, Inc.1,614
进行中（未招募）
1 期
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDModerate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 19.0Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855EUCTR2014-004712-10-PLPearl Therapeutics, Inc.1,614
进行中（未招募）
1 期
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDEUCTR2014-004712-10-CZPearl Therapeutics, Inc.1,614
进行中（未招募）
1 期
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPDModerate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 19.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855MedDRA version: 19.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855EUCTR2014-004712-10-HUPearl Therapeutics, Inc.1,614