The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in body weight and body composition
研究概览
简要总结
Specific policies on obesity reduction often include a recommendation to reduce sugar consumption as a means of lowering overall caloric intake. Reformulating processed foods (e.g. sugary products) is considered one of the key options for improving population diet. The implications of regular consumption of reformulated products are not fully understood. Previous studies have demonstrated that dietary compensation is common, although the extent is not fully elucidated. In addition to the perceived impact of sugar consumption on weight control, high sugar intake, specifically sucrose and fructose, has been implicated in the increase of plasma lipids and markers of insulin resistance. However to date no randomised controlled study has investigated whether the consumption of reformulated low sugar products as components of a habitual diet have a significant impact on plasma lipid, insulin or glucose concentrations within a free-living, non-diseased population. It is hypothesised that exchange of reformulated, low sugar food products for habitually consumed foods will result in dietary compensation and minimal weight change compared with unmodified products and will have little impact on plasma glucose, insulin and lipid levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 20 - 49 years
- •BMI 18.5 - 30 kg/m2
- •Plasma glucose <7 mmol/l (Not diagnosed with diabetes)
- •Plasma cholesterol <7 mmol/l
- •Plasma TAG <2.3 mmol/l
- •Normal liver and kidney function
- •Haemoglobin (>110 g/l women; 140g/dl men)
排除标准
- •Having suffered a myocardial infarction/stroke in the past 12 months
- •diabetic (diagnosed or fasting glucose > 7 mmol/l)
- •On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- •Suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- •Excessive alcohol consumption
- •History of alcohol abuse
- •Following a reducing diet or vegan diet
- •Taking any fish oil, fatty acid or vitamin and mineral supplements
- •Participating in intensive aerobic activity for > 20 minutes 3 times per week
- •Food allergies
- •Anti-inflammatory usage
结局指标
主要结局
Changes in body weight and body composition
时间窗: 20 weeks. Baseline and week 8 assessments for two dietary intervention arms
次要结局
- Changes in energy and nutrient intake(20 weeks. Run-in period and week 7 assessments for two dietary intervention arms)
- Changes in physical activity levels(20 weeks. Run-in period and week 7 assessments for two dietary intervention arms)
- Changes in appetite and mood ratings(20 weeks. Run-in period and week 7 assessments for two dietary intervention arms)
- Changes in fasting plasma lipid, insulin and glucose concentrations(20 weeks. Baseline and week 8 assessments for two dietary intervention arms)
- Changes in cardiovascular risk factors (blood pressure, inflammatory markers)(20 weeks. Baseline and week 8 assessments for two dietary intervention arms)
- Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)(20 weeks. Baseline and week 8 assessments for two dietary intervention arms)
研究者
Julie Lovegrove
Professor of Metabolic Nutrition
University of Reading