ACTRN12619000436178已完成未知
Impact of Ubiquinol Supplementation on Endothelial Function in Subjects at Risk of Cardiovascular Disease Development: a Double Blind, Randomized, Placebo–controlled, Parallel Groups, Spontaneous Clinical Study
I.N.R.C.A. (Italian National Research Centre on Aging)-IRCCS0 个研究点目标入组 51 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 35 Years 至 65 Years（—）
- 性别
- All
入选标准
- •This study will include male and post-menopausal female subjects.
- •- Male aged 35 - 65 years (35 and 65 included).
- •- Post-menopausal female (without a period for more than 1 year), until 65 years (65 included).
- •- Subjects enrolled for primary prevention but never treated (only life style modification suggested, according guidelines).
- •- FMD level measured between 2,5% and 6% (at Screening Visit).
- •- Body mass index (BMI) between 18.5 and 29.9 kg/m2.
- •- LDL Cholesterol levels between 130 and 200 mg/dl (based on previous evaluation, performed within 1 month from the Screening Visit).
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following apply:
- •- Use of any cardiovascular disease related drugs prior to Screening Visit.
- •- Participation in any clinical trial while participating in this trial.
- •- Greater than 5% change in body weight within 1 month of Screening Visit.
- •- Subjects playing competitive physical activity.
- •- Subject taking lipid-altering drug therapy within four weeks prior to Screening Visit. Also excluded are supplements known to have significant lipid altering effects, such as niacin (>100 mg per day), garlic (> 600 mg per day), omega-3 fatty acids (> 1 g omega-3 fatty acids per day), red yeast rice extract, phytostanols / phytosterols (> 0.5 g per day), soluble fiber (>1 g per day), chitosan (> 1 g per day) and conjugated linoleic acid (CLA; > 3 g per day).
- •- Subject taking any concomitant treatment with phosphodiesterase inhibitors (e.g. sildenafil citrate, tadalafil, vardenafil) and donors of NO (nitric oxide), like other long-acting derivatives of GTN (glyceryl trinitrate), such as isosorbide dinitrate and amyl or butyl nitrite.
- •- Excluded concurrent medications are: systemic corticosteroids (nasal and inhaled corticosteroids are permitted), orlistat, bile acid resins, no more than 1 g of prescription omega-3 fatty acids, cyclical or non-continuous hormone therapy (estrogen or testosterone).
- •- No more than 2 alcoholic units per day. Units are defined as 12 grams of ethanol, e.g. a small glass (125 ml) of medium gradation wine, a can of beer (330 ml) of average gradation or 40 ml dose of liquors.
- •- Consumption of flavonoids-enriched products.
- •- Consumption of vitamin C-enriched products or supplements containing vitamin C.
- •- Has a diagnosis of type 1 or type 2 diabetes mellitus, hepatic or renal impairment or diseases, thyroid disorders.
- •- Known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by Principle Investigator or Sub-investigator, or study site physician (e.g. clinically insignificant atherosclerotic lesions observed by imaging studies).
- •- History of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis).
- •- History of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study.
- •- History if cancer within 5 years of Screening Visit (except for successfully treated basal and squamous cell carcinoma of the skin).
- •- Known HIV seropositivity.
- •- History of bariatric surgery.
- •- Allergic to the test products or placebo.
- •- Smokers > 10 cigarettes/day.
- •- Individuals who in the opinion of the principal investigator have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
研究者
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