NCT03719794已完成不适用
Probiotics for Vascular Inflammation in Metabolic Syndrome (PROMISE): a 12-Week Pilot Study, Randomized,Double-Blinded, Placebo-Controlled Trial
Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年4月16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
- 24
- 试验地点
- 2
- 主要终点
- The primary outcome is to evaluate the change on vascular inflammation (measured by FDG-PET), so as to test the hypothesis that probiotic treatment reduces vascular inflammation in comparison to placebo.
研究概览
简要总结
Subjects with metabolic syndrome are known to possess chronic low-level inflammation. Furthermore, such individuals are at risk of developing atherosclerosis in coronary and other vascular beds. In particular, subjects with metabolic syndrome, prediabetes and type II diabetes mellitus were shown to possess vascular inflammation in carotid atherosclerosis as demonstrated using FDG-PET. In the current pilot proposal, the investigators wish to study the impact of 3-month probiotic supplementation on vascular and systemic inflammation in subjects with metabolic syndrome in the context of a randomized, placebo-controlled, pilot trial.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female age > 50 years
- •Presence of MetS as defined according to recent updated criteria (13): Presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off) depending on the recently published ethnic-based variations (14), triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.
- •Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
- •Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements).
- •Able to provide informed consent.
排除标准
- •Concurrent consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements). Subjects will be eligible for participation, however, after a two-week washout period
- •Overt or documented vascular disease (coronary heart disease, cerebrovascular disease, or peripheral vascular disease).
- •Participants suffering from dementia (mini mental state examination) or depression (geriatric depression scale).
- •Concurrent statin therapy. (Statins have been shown to reduce vascular inflammation as measured by FDG-PET-see section 9.1).
- •Color blind
- •Concurrent antibiotic therapy. However, screened participants would be eligible to participate two weeks after completing their course of antibiotics (wash-out period).
- •Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
- •Women of childbearing potential not using effective contraception. Acceptable methods of birth control includes:
- •Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants;
- •Intrauterine devices (IUD) or Intrauterine system (IUS);
- •Tubal ligation;
- •Vasectomy of partner;
- •Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap).
- •Positive pregnancy test in women of childbearing potential.
- •Allergy to milk, soy, or yeast.
- •Use of another investigational product within 3 months of the screening visit.
- •Claustrophobia
- •Patient with pacemaker
- •Patient with BMI greater than 40 kg/m2
- •Immune disorder.
- •Drug and alcohol abuse
- •Current use of NSAIDs
- •Liver and kidney disorders
- •Bleeding/blood disorder
结局指标
主要结局
The primary outcome is to evaluate the change on vascular inflammation (measured by FDG-PET), so as to test the hypothesis that probiotic treatment reduces vascular inflammation in comparison to placebo.
时间窗: At baseline and following 12 weeks of probiotic supplementation or placebo.
PET-CT scan of the carotid arteries and ascending thoracic aorta will be performed 2 hours post I.V. The participant will be injected with 18F-FDG.
次要结局
- Mesure of Tumor necrosis factor alpha (TNF-α) a systemic inflammatory marker.(At baseline and following 12 weeks of probiotic supplementation or placebo.)
- Mesure of High-sensitivity C-reactive protein (hs-CRP) a systemic inflammatory marker.(At baseline and following 12 weeks of probiotic supplementation or placebo.)
- Mesure of Matrix metallopeptidase 9 (MMP-9)(At baseline and following 12 weeks of probiotic supplementation or placebo.)
- Cognitive function at rest by a standard pen-paper battery test.(At baseline and following 12 weeks of probiotic supplementation or placebo.)
- Intestinal microbiota community composition(At baseline and following 12 weeks of probiotic supplementation or placebo.)
研究者
研究点 (2)
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