NCT01630668已完成2 期
Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.
研究概览
简要总结
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.
Objective: The purpose of the study is to determine the lipid lowering efficacy of a One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12 weeks in subjects with hypercholesterolemia.
Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period and a 12-week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Males and females, aged 20 to 75 years (bounds included).
- •LDL-C ≥ 3.40 mmol/L (<15% variation between visits V0 and V2-1).
- •TG < 4.00 mmol/L (confirmed at visits V0 and V2-1).
- •BMI range will be 23.0 to 32.5 kg/m2 (bounds included).
- •Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines).
- •Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated.
- •Signed informed consent form prior to inclusion in the study.
- •Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.
- •If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- •Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- •Intrauterine devices
- •Vasectomy of partner
- •Total abstinence
排除标准
- •Use of cholesterol lowering prescription drugs within the last 6 months.
- •Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription supplements within last 1 month.
- •History of chronic use of alcohol (> 2 drinks/d).
- •History of heavy smoking (≥ 20 cigarettes/d).
- •Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
- •Immune-compromised subjects (e.g. AIDS, lymphoma, subjects undergoing long-term corticosteroid treatment)
- •Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months.
- •Subjects with elevated LDL-C (≥ 3.40 mmol/L) and high (>20%) CVD risk estimated by the Framingham risk score.
- •Previously diagnosed Type I or Type II diabetes.
- •Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
- •Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
- •History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
- •Clinically significant abnormal laboratory results at screening.
- •Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives.
- •History of eating disorders.
- •Exercise greater than 15 miles/wk or 4,000 kcal/wk.
- •For female subjects: Pregnancy, breast feeding, or intent to get pregnant.
- •Allergy or sensitivity to test product ingredients
- •Allergy or sensitivity to all 3 antibiotics (Clindamycin, Erythromycin and Ampicillin).
研究组 & 干预措施
One-a-Day L. reuteri NCIMB 30242 supplement capsule
Experimental
干预措施: One-a-Day L. reuteri NCIMB 30242 supplement capsule (Dietary Supplement)
One-a-Day placebo capsule
Placebo Comparator
干预措施: One-a-Day placebo capsule (Dietary Supplement)
结局指标
主要结局
The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.
时间窗: Week 0 and Week 12 of intervention period
次要结局
未报告次要终点
研究者
研究点 (1)
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