NCT02635594已完成不适用
Effects of Carnipure® Tartrate on Postprandial Endothelial Function and Recovery From Physical Exertion in Healthy People - a Randomized, Double-blind, Placebo-controlled, Two-way Cross-over Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lonza Ltd.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- postprandial endothelial function
研究概览
简要总结
Investigation of 4 weeks supplementation with Carnipure® tartrate on endothelial function and parameters of recovery after physical exertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between 25 and 45 years
- •Body mass index (BMI) between 20 and 30 kg/m²
- •Non-smoker
- •Physically active 1-2 times per week
排除标准
- •Competitive athlete or performance of high intensity training
- •Nutrition with high portion of meat (> 3 times meat per week).
- •Injury at the finger
- •History or presence of significant cardiovascular disease or co-morbidities (i.e., diabetes, etc.)
- •Known allergy to ingredients of study preparation
- •Disturbed absorption due to changes in the gastrointestinal tract (e.g., resections, diverticula, blind-loop syndrome)
- •Hypo/ hypertension or taking anti hypo/ hypertension medication
- •Untreated thyroid dysfunction
- •Atherosclerosis or other relevant musculoskeletal diseases/ injuries
- •Anemia (women: Hb <11 g/ dl; men: 12.5 g/ dl)
- •Eating disorder
- •Present or recent use of drugs and dietary supplements that affect the endothelial function, re-covery or lipid status 2 months before or during the study (e.g. L-Carnitine, Arginine, omega3 FA, polyphenol rich supplements (e.g. OPC, cacao, etc) antihypertensive drugs, anti hyperlipidemic drugs, regular intake of protein-shakes etc.)
- •Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1b and 3b.
- •Female patients that are pregnant or nursing
- •Night shift worker
- •Donation of blood or similar blood loss within the previous 30 days before screening;
- •Participation in a clinical trial with an investigational product within 30 days before screening
- •Known alcohol abuse or drug abuse
- •Known infection of human immunodeficiency virus (HIV) or hepatitis B or C
- •Known lactose intolerance, dairy protein allergy or allergy to nuts
研究组 & 干预措施
Placebo
Placebo Comparator
1000mg cellulose + 475mg L-tartaric acid
干预措施: Placebo (Other)
Carnipure® tartrate
Experimental
1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate
干预措施: L-Carnitine (Dietary Supplement)
结局指标
主要结局
postprandial endothelial function
时间窗: after 4 weeks supplementation
postprandial endothelial function assessed after 4 weeks supplementation with verum in comparison to placebo
次要结局
- Creatin Kinase (CK) before and after exhaustive exercise(immediately before, 0h, 2h, 24h, 48h,)
- Myoglobine (Mb) before and after exhaustive exercise(immediately before, 0h, 2h, 24h, 48h,)
- Biomarker for vascular health(after 4 weeks supplementation)
- Maximal strength (Nm) before and after exhaustive exercise(immediately before, 0h, 2h, 24h, 48h,)
- pain before and after exhaustive exercise (VAS)(immediately before, 0h, 2h, 24h, 48h,)
研究者
研究点 (1)
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