NCT02622425已完成2 期
The Effect of the Carotenoid-producing Bacillus Strain PD01 on Cardiovascular Health and Microbial Environment
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Effect on lipid peroxidation measured urinary F2-isoprostane excretion
研究概览
简要总结
This randomized, placebo-controlled trial aims to determine the effects of daily administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on cardiovascular health biomarkers, microbiota composition and functioning and intestinal barrier function in overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight men/women (BMI 25-35 kg/m2)
- •Healthy individuals
- •Age between 18 and 70 years
- •Fasting glucose < 7.0 mmol/L
- •Normal HbA1c (4.4 to 6.2%)
排除标准
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
- •History of (severe) cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- •Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
- •Use of medication interfering with endpoints
- •Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- •Use of antibiotics in the 90 days prior to the start of study
- •Known pregnancy, lactation
- •Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- •Blood donation within 3 months before study period
- •Plans to lose weight or following a hypocaloric diet during the study period;
- •Weight gain or loss > 3 kg in previous 3 months
- •High physical activity (>4.5 hours of running/week)
- •Hormone replacement therapy (women)
- •History of any side effects towards intake of pro- or prebiotic supplements of any kind
- •History of any side effects towards intake of carotenoids
- •Prohibited use of pro-, pre- or synbiotics during study period and from one month prior to start of study.
- •High intake of fruits and vegetables (more than the 75th percentile of dietary intake of fruits and vegetables)
- •Vegetarians/vegans
研究组 & 干预措施
Placebo
Placebo Comparator
Maltodextrin
干预措施: Placebo (Dietary Supplement)
PD01
Active Comparator
Carotenoid-producing Bacillus strain PD01
干预措施: PD01 (Dietary Supplement)
结局指标
主要结局
Effect on lipid peroxidation measured urinary F2-isoprostane excretion
时间窗: 6 weeks
The primary objective of this study is to evaluate the efficacy of PD01 on lipid peroxidation by measuring F2-isoprostane excretion in 24-hour urine, after 6 weeks of administration.
次要结局
- To assess the bioavailability of PD01 by measuring blood carotenoid concentration(6 weeks)
- Effect on lipid peroxidation measured by blood concentration of F2-isoprostanes(6 weeks)
- Effect on lipid peroxidation measured by blood total antioxidant capacity(6 weeks)
- Effect on lipid peroxidation measured by blood MDA concentration(6 weeks)
- Effect on low-grade inflammation measured by blood concentration of TNFalfa(6 weeks)
- Effect on platelet aggregation measured by blood concentration of P-selectin(6 weeks)
- Effect on blood glucose concentrations measured by blood glucose concentration(6 weeks)
- Effect on blood lipid profile(6 weeks)
- Effect on blood pressure(6 weeks)
- Effect on body composition measured by BMI(6 weeks)
- Effect on body composition measured by waist-hip circumference (WHC)(6 weeks)
- The effect on fecal microbial community composition measured by fecal microbial community composition(6 weeks)
- The effect on fecal microbial community composition measured by fecal short chain fatty acids (SCFA)(6 weeks)
- Effect on gut barrier function measured by a sugar test(6 weeks)
- Effect on digestive tolerance measured by GSRS questionnaire(6 weeks)
- Effect on digestive tolerance measured by Bristol Stool Chart(6 weeks)
研究者
Bouke Salden
MD
Maastricht University Medical Center
研究点 (1)
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