NCT02871362已完成不适用
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of IQP-AS-118 on Blood Pressure and LDL-cholesterol: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Blood Pressure (Systolic & Diastolic)
研究概览
简要总结
The purpose of this study is to evaluate the benefit and tolerability of IQP-AS-118 on the systolic and diastolic blood pressure (BP) and to explore the effects on parameters of lipid metabolism in subjects with elevated BP and low density lipoprotein cholesterol (LDL-C) levels in a pilot study.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian males and females, 18-65 years of age
- •Body mass index (BMI) 18.5-29.9 kg/m2
- •Generally in good health, in particular an electrocardiogram (ECG) without pathological findings at screening
- •High normal BP levels (130-139 / 85-89) for 20% of randomized subjects and hypertension grade 1 (140-159 / 90-99) BP levels for 80% of randomized subjects at screening (mean of the 2nd and 3rd measurement during the assessment in triplicate at screening) and at baseline (mean of the 2nd and 3rd measurement during the assessment in triplicate at week 0)
- •LDL-C 100-159 mg/dL
- •Readiness to comply with study procedures, in particular:
- •Consumption of the IP during the entire study
- •Maintaining the habitual diet, with the exception of consumption of maximal 2 garlic cloves per week
- •Accepting blood draws
- •Complying with requirements for BP measurements (such as avoiding any strenuous exercise and stimulants (alcohol, caffeine) for at least 24 h before the measurement; refraining from extreme cold and heat exposure and food and fluid intake for at least 1 h before the measurement)
- •Filling in health questionnaires
- •Non-smoker / smoking cessation of last ≥12 months prior to screening
- •Stable body weight in the last 3 months prior to screening (<3 kg self-reported change)
- •If allowed concomitant medications are taken this must have been stable at least during the last month prior to screening
- •Women of child-bearing potential only:
- •negative pregnancy testing (ß-HCG in urine at screening)
- •commitment to use reliable contraception methods during the entire study Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
排除标准
- •Known sensitivity to any components of the IP
- •Clinically significant disturbances in lipid metabolism
- •Known genetic hyperlipidemia
- •Known secondary hypertension
- •Known white-coat hypertension
- •Known type-1-diabetes
- •Uncontrolled or within the last 6 months prior to screening diagnosed type-2-diabetes
- •Untreated or non-stabilized thyroid disorder
- •History and/or presence of clinically significant cardiovascular disease as per investigator's judgement:
- •Known congenital heart defects
- •Myocardial infarction, heart failure, angina pectoris, life-threatening arrhythmia or stroke within the last 6 months prior to screening
- •Existing thrombosis or disposition to thrombosis
- •Any other known significant or serious condition / disease that renders subjects ineligible, e.g.:
- •History of malignancy within the past 5 years prior to screening
- •Bleeding disorder and/or need for anticoagulants (anti-platelet agents are allowed)
- •Current psychiatric care and/or use of neuroleptics
- •Bariatric surgery in the last 12 months prior to screening
- •Any known metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subject
- •Known arm lymphedema (e.g. due to mastectomy)
- •Other clinically relevant excursions of safety parameters and/or deviations > 2 x ULN (upper limit of normal)
- •Dietary habits that may interfere with the study objectives:
- •Eating disorder
- •Subjects with dietary restriction that may affect the study outcome
- •Participation in a weight loss program
- •Use of drugs or supplements that can influence SBP or DBP (e.g. ACE inhibitors, diuretics, calcium channel or ß-blockers, grape seed extract, coenzyme Q10 etc.) within the last 4 weeks prior to screening and during the study
- •Use of lipid lowering drugs (affecting lipid metabolism, platelet function or antioxidant status, etc.) OR dietary or health supplements (e.g. omega-3 fatty acids, green tea extract, calcium, red yeast rice, phytosterols (incl. enriched products such as e.g. Becel), oat fiber, niacin, soy protein, psyllium seed husk, glucomannan, chitosan or probiotics/prebiotics) within the last 4 weeks prior to screening and during the study
- •Use of drugs that can influence cholesterol levels (e.g. corticosteroids, amiodarone, estrogen, anabolic ster-oids)
- •Use of weight loss treatment
- •Use of any recreational drugs
- •Alcohol abuse (men: ≥21 units/week, women: ≥14 units/ week; 1 unit equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
- •Women of child-bearing potential: pregnant or breast-feeding
- •Participation in another study or blood donation during the last 30 days prior to screening
- •Any other reason deemed suitable for exclusion as per investigator's judgment, e.g.:
- •Insufficient compliance with study procedures
- •Inability to communicate with the site study staff
结局指标
主要结局
Blood Pressure (Systolic & Diastolic)
时间窗: 12 weeks
Week 12 vs. week 0
次要结局
- Fasting Lp (a) concentrations(12 weeks)
- Pulse wave assessment(12 weeks)
- Metabolome analysis(12 weeks)
- Systolic blood pressure(12 weeks)
- Homocysteine(12 weeks)
- Global evaluation of benefit by the subjects/ investigator(12 weeks)
- Diastolic blood pressure(12 weeks)
- Fasting LDL-C concentration and non-HDL-C(12 weeks)
- Fasting TC Concentration(12 weeks)
- Fasting HDL-C Concentration(12 weeks)
- Fasting TG Concentration(12 weeks)
- Fasting LDL-C/HDL-C and TC/HDL-C ratio(12 weeks)
- hs-CRP(12 weeks)
- SF-12(12 weeks)
研究者
研究点 (2)
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