NCT01963416已完成不适用
A Randomized Controlled, Crossover in Design, Double Blind Clinical Trial Investigating the Effects of Whole Versus Processed Fruit Consumption on Risk Factors for Chronic Disease and Performance Indicators.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Flow mediated dilation
研究概览
简要总结
Acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (FMD) and additional biomarkers of health. The study will also identify and quantify the main micronutrients and phytochemicals in each of the products and will identify and quantify the main micronutrients and phytochemicals and their metabolites in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited to participate in an additional arm of the main study which is summarised below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males due to potential hormonal fluctuations in female subjects
- •Aged 30-65years
- •Fasting total cholesterol in the upper half of the normal range (6.0-8.0 mmol/l) or triacylglycerol >0.8 mmol/l or a BMI 25-32 kg/m
- •Not having suffered a myocardial infarction/stroke in the past 12 months
- •Not diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- •Not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- •Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- •No history of alcohol misuse
- •Not planning or on a weight reducing regime
- •Not taking any fish oil, fatty acid or vitamin and mineral supplements
- •Non smokers
- •Not suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11).
- •Not suffering from mild cognitive impairment or dementia according to the MMSE (score ≥ 25).
排除标准
- •Medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation
- •Hypertension - ACE Inhibitors (e.g. Captopril, Cilazapril), Angiotensin Receptor Blockers (Valsartan), Calcium Channel Blockers (Amlodipine, Nicardipine), Diuretics (Chlortalidone) or Beta blockers (Sotalol, Bisoprolol).
- •Cholesterol lowering (Pravastatin, Simuvustatin)
- •Anticoagulants (Warfarin)
- •Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids(Betamethasone)
- •Strict vegetarians
- •Those on or planning a weight reducing regime
- •Blood glucose, haemaglobin or liver enzymes outside of the normal range
- •Unable to consume study meals
- •Those suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11).
- •Those suffering from mild cognitive impairment or dementia as indicated by the MMSE (score < 25).
结局指标
主要结局
Flow mediated dilation
时间窗: change in Flow Mediated Dilation response between baseline and 6 hours
次要结局
- Postprandial plasma glucose(change in glucose from baseline to 2 hours)
- Postprandial insulin(change from baseline to 2 hours)
- global cognitive function(change from baseline to 6 hours)
- Blood pressure(change from baseline to 6 hours)
- postprandial non-esterified fatty acids(change from baseline to 6 hours)
- Postprandial triacylglycerol(change from baseline to 6 hours)
- total HDL/LDL(change from baseline to 6 hours)
- Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)(change from baseline to 6 hours)
- LDL oxidation(change from baseline to 6h)
研究者
Jeremy Paul Edward Spencer
Professor of Nutritional Medicine
University of Reading
研究点 (2)
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