NCT02734706已完成不适用
Efficacy of a Supplement Capsule Containing LRC™ (L. Reuteri NCIMB 30242) on Managing Cholesterol Levels in Adults
UAS Labs LLC2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Serum LDL-cholesterol after 9 weeks of product consumption.
研究概览
简要总结
To investigate the effect of a supplement capsule containing LRC™ (L. reuteri NCIMB 30242), taken twice daily with lunch and dinner (NLT 2.5E9 CFU per dose), versus placebo capsule on serum low density lipoprotein (LDL)-cholesterol in otherwise healthy hypercholesterolemic adults after 9 weeks of product consumption.
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.
- •LDL-C ≥ 3.40 mmol/L at visits V0 and V2-1 (<15% variation between visits V0 and V2-1).
- •TG < 4.00 mmol/L (checked at visits V0 and V2-1).
- •BMI between 23.0 to 32.5 kg/m
- •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.
- •Subjects taking stable doses of thyroid hormone and anti-hypertensive agents will be permitted, as long as these are continued equivalently throughout the duration of study.
- •Agreement to maintain current level of physical activity throughout the 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.
- •Voluntary, written, informed consent to participate in the study.
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 or any other endocrine disorders such as adrenal insufficiency, Cushing's disease, hyperthyroidism, hypopituitarism or polycystic ovary syndrome.
- •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).
- •Diagnosis of anemia or bleeding disorders
研究组 & 干预措施
LRC™ capsule
Experimental
干预措施: LRC™ capsule (Dietary Supplement)
Placebo capsule
Placebo Comparator
干预措施: Placebo capsule (Other)
结局指标
主要结局
Serum LDL-cholesterol after 9 weeks of product consumption.
时间窗: 9 weeks
次要结局
- Serum total cholesterol after 6 and 9 weeks of product consumption.(6 and 9 weeks)
- Serum LDL-cholesterol after 6 weeks of product consumption.(6 weeks)
- Serum HDL-cholesterol after 6 and 9 weeks of product consumption.(6 and 9 weeks)
- Plasma fibrinogen after 9 weeks of product consumption.(9 weeks)
- GI health questionnaire score after 6 and 9 weeks of product consumption.(6 and 9 weeks)
- Plasma homocysteine after 9 weeks of product consumption.(9 weeks)
- Serum triglycerides after 6 and 9 weeks of product consumption.(6 and 9 weeks)
- Serum apolipoprotein B-100 after 6 and 9 weeks of product consumption.(6 and 9 weeks)
- Serum non-HDL-cholesterol after 6 and 9 weeks of product consumption.(6 and 9 weeks)
- Serum hs-CRP after 9 weeks of product consumption.(9 weeks)
研究者
研究点 (2)
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