The Impact of Reformulated Foods on Cardiovascular Risk Factors (REFORM)
2014年12月3日 更新者:Julie Lovegrove、University of Reading
The Impact of Reformulated Product Consumption on Energy and Nutrient Intake, Body Composition, Vascular Function and Plasma Lipid and Glucose Concentrations
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.
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Berks
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Reading、Berks、英国、RG6 6AP
- Department of Food and Nutritional Sciences, University of Reading
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 49年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Having suffered a myocardial infarction/stroke in the past 12 months
- diabetic (diagnosed or fasting glucose > 7 mmol/l)
- Smoking
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Reformulated products
Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks.
Subjects were provided with reformulated beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
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Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks.
Subjects were provided with reformulated beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
其他名称:
|
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实验性的:Conventional products
Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks.
Subjects were provided with conventional beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
|
Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks.
Subjects were provided with conventional beverages, sauces, condiments and snacks.
They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Changes in body weight and body composition
大体时间:20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in energy and nutrient intake
大体时间:20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
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Changes in appetite and mood ratings
大体时间:20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
|
Subjective sensations of appetite and mood by visual analogue scale
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
|
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Changes in physical activity levels
大体时间:20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
|
Measured by accelerometry
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20 weeks. Run-in period and week 7 assessments for two dietary intervention arms
|
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Changes in fasting plasma lipid, insulin and glucose concentrations
大体时间:20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Changes in vascular stiffness by pulse wave analysis (PWA) and digital volume pulse (DVP)
大体时间:20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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Changes in cardiovascular risk factors (blood pressure, inflammatory markers)
大体时间:20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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20 weeks. Baseline and week 8 assessments for two dietary intervention arms
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Prof Julie A Lovegrove, BSc, PhD, RNutr、University of Reading
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Reid M, Hammersley R, Duffy M. Effects of sucrose drinks on macronutrient intake, body weight, and mood state in overweight women over 4 weeks. Appetite. 2010 Aug;55(1):130-6. doi: 10.1016/j.appet.2010.05.001. Epub 2010 May 12.
- Reid M, Hammersley R, Hill AJ, Skidmore P. Long-term dietary compensation for added sugar: effects of supplementary sucrose drinks over a 4-week period. Br J Nutr. 2007 Jan;97(1):193-203. doi: 10.1017/S0007114507252705.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2012年7月18日
首先提交符合 QC 标准的
2012年7月18日
首次发布 (估计)
2012年7月20日
研究记录更新
最后更新发布 (估计)
2014年12月4日
上次提交的符合 QC 标准的更新
2014年12月3日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.