NCT01175577已完成早期 1 期
Evaluating the Effects of Mixed-Carotenoids on Biomarkers of Endothelial Dysfunction
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in serum carotenoid fraction concentrations between study arms
研究概览
简要总结
The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •adults aged 18-65
- •in good health by the absence of exclusion criteria on standardized medical history interview
- •willingness to be randomized
- •willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days
排除标准
- •children <18 years
- •current use of carotenoid supplements (not including typical multivitamins containing beta-carotene)
- •current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract
- •current use of aspirin, statins or regular (>2 per week) use of NSAID medications
- •current smoking or past smoking greater than 3 packs total or currently living with a smoker
- •excessive alcohol intake (> 3 drinks per day) or history of alcoholism
- •known exposure to asbestos
- •autoimmune disease
- •hemachromatosis
- •history of gallbladder disease including gall stones or gall bladder removal
- •pre-diabetes, metabolic syndrome or diabetes (1 or 2)
- •established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage II hypertension (≥160/90; stage II technically diastolic ≥100mmHg, will maintain diastolic cutoff of 90mmHg), past MI or stroke)
- •renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver")
- •acute infection except viral colds
- •residual injury/pain/limitation from trauma
- •chronic musculoskeletal disorders including osteoarthritis requiring pain medications
- •psychiatric disorders that would impair completion of research tasks
- •allergies to supplied foods
- •anyone on a medically-prescribed diet
- •>3.5 servings fruits/veggies per day
- •inability to consume entire study Control meal w/in specified timeline (30 minutes)
- •current pregnancy or breast feeding
- •refusal to participate in blood draws following the control meal.
结局指标
主要结局
Change in serum carotenoid fraction concentrations between study arms
时间窗: Following 28 day intervention
次要结局
- Change in serum antioxidant capacity (ORAC)(Following 28 day intervention)
- Change in lipid profile (LDL, HDL, triglycerides)(Following 28 day intervention)
- Change in oxidized LDL lipoproteins (oxLDL)(Following 28 day intervention)
- Change in serum gamma-glutamyl transferase (GGT)(Following 28 day intervention)
- Change in C-reactive protein (CRP)(Following 28 day intervention)
- Change in urinary isoprostanes(Following 28 day intervention)
研究者
Ryan David Bradley
Research Assistant Professor
Bastyr University
研究点 (4)
Loading locations...
相似试验
已完成
早期 1 期
Carotenoids for Collision AthletesHead InjuryCarotenoidsNCT06270680Penn State University31
Unknown
不适用
Molecular Effects of a Multi-carotenoids (MCS) New Agent on Prostate Cancer ChemopreventionProstate CancerNCT02426216National Taiwan University Hospital300
已完成
不适用
Correlation Between Skin Carotenoid Levels and Previous History of Skin CancerSkin CancerBasal Cell CarcinomaSquamous Cell CarcinomaNCT00836342Massachusetts General Hospital81
已完成
不适用
Can an increase in fruit and vegetable intake improve/change your skin colour and appearance?Young women from the general population not following any dietary restriction due to medical conditionsNutritional, Metabolic, EndocrineISRCTN86297454The University of Newcastle (Australia)30
已完成
不适用
The influence of vegetable juice intake on blood and skin carotenoid levels.ot applicableJPRN-UMIN000028320Kagome Co.Ltd.26