An Investigation Into the Effects of Orange Juice on Plasma Lipids - an Extension to J/06/2010
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Total Serum Cholesterol concentration
研究概览
简要总结
The aim of this study is primarily to investigate the ability of antioxidants found in orange juice (OJ) to improve the serum lipid profile. Overweight or mildly obese men, who are otherwise healthy, but with elevated serum total cholesterol concentration will be recruited. The time commitment for subjects is ~14wks. Subjects will attend the laboratory on 5 occasions after fasting from midnight. The 1st is a medical screening. Laboratory visits 2 & 5 will take ~90min and will be separated by 3 months, during which time subjects will consume 250ml of an orange drink (either OJ or an orange flavoured control drink) once a day. During visits 2 & 5, subjects will have a scan to assess their %body fat using a low-dose x-ray machine, a 20ml blood sample taken and a small sample of fat tissue (about the size of a haricot bean)taken from underneath the skin of the belly. Subjects will record their food intake for 3-days in weeks 3, 7 and 11 of consuming the drink, and come to the lab for visits 3&4 during weeks 4&8. Laboratory visits 3&4 repeat measurements taken in the 1st (screening) visit.
详细描述
Background:
Overweight and mild obesity are associated with insulin resistance and mild elevations in lipid risk factors which are not usually sufficiently abnormal to merit treatment. Such people are encouraged to lose weight to reduce their risk of progressing to type 2 diabetes and coronary heart disease, but there is clearly a potential role for dietary modifications to maximize any potential benefit of this weight loss. Flavonoids are known to have vascular effects which might enhance substrate delivery to metabolically active tissues, and thus improve insulin sensitivity. Moreover, there is much interest in the potentially beneficial effect of flavonoids on serum lipid profile.
There are many different dietary sources of flavonoids, with fruits such as apples, berries and citrus being rich sources. However, some researchers have expressed concern that a high dietary intake of 100% juice may contribute to the development of insulin resistance, obesity and the Metabolic Syndrome (Bazzano, Li et al. 2008), although this is not universally accepted (Fujioka, Greenway et al. 2006; O'Neil and Nicklas 2008). To date, there have been no studies investigating the effects of citrus fruits on indices of cardio-metabolic health in people who are presently healthy but are at risk of developing some features of the Metabolic Syndrome.
Aims:
To investigate the effects of orange juice (OJ) intake on appetite hormones, blood pressure and plasma lipids. In addition we aim to investigate any gene expression changes associated with OJ consumption, in particular in adipose tissue.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 27-35
- •waist circumference >96cm.
- •Serum Total Cholesterol >5mmol/l
排除标准
- •Any clinically significant metabolic or endocrine abnormalities
- •screening blood results (other than lipids) outside of the normal range
- •fasting total cholesterol >7.0mmol/l
- •taking routine medication
- •herbal supplement use
- •food allergies or sensitivities related to the investigational product Regular citrus consumers (whole fruit or juice) daily consumption of sucrose or high fructose corn syrup containing soft-drinks
研究组 & 干预措施
Orange Juice
Juice high in flavonoids
干预措施: Orange Juice (Dietary Supplement)
Orange Drink
Sugars matched, low flavonoids orange drink
干预措施: Orange Juice (Dietary Supplement)
结局指标
主要结局
Total Serum Cholesterol concentration
时间窗: after 3 months' intervention
Fasting Serum total cholesterol concentration (mmol/l)
次要结局
- GLP-1(After 3 months intervention)
- Low density cholesterol(after 3 months' intervention)
- High Density Cholesterol (HDL)(after 3 months' intervention)
- leptin(after 3 month intervention)
- IL-1(afetr 3 month intervention)
- Ghrelin(After 3 months intervention)
- IL-6(After 3 months intervention)
- Gene expression in adipose tissue(after 3 months' intervention)
- Blood Pressure(after 3months intervention)
- insulin(After 3 months intervention)
- TNF alpha(After 3 months intervention)
研究者
Elizabeth Simpson
Senior Research Fellow
University of Nottingham