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临床试验/NCT02491801
NCT02491801已完成不适用

The Effect of Solid, Semi-solid and Liquid Dairy Products on Satiety, Food Intake and Post-meal Glycaemia in Young and Older Adults

University of Toronto2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Blood Glucose (Study 1, 2 and 3)

研究概览

简要总结

The proposed study is planned to determine the potential role for regular fat dairy products in short-term metabolic control in younger and older adults and the metabolic flexibility in response to food components, which are areas that have not yet been explored. Subjects would be served with solid (cheese), semi-solid (yogurt) and liquid (milk) dairy products and skim milk (control) and water (non-caloric control) in three separate studies.

详细描述

Over the last 30 years, overweight and obesity have become characteristic of the majority of Canadians. Approximately 60% of adults in Canada are overweight or obese. The Canadian Health Measures Survey, conducted during 2007-2009, estimated prevalence of metabolic syndrome at 19.1% in the adult population. In addition, according to the 2010 Canadian Community Health Survey, 18.1% of Canadian adults have been reported obese. Along with the health burden, it has also brought about an estimated economic burden of $ 4.3 billion annually in 2001, which has likely doubled as of today.

Metabolic syndrome and type 2 diabetes occur concurrently with insulin resistance marked by increased blood glucose levels at fasting and postprandial, glycosylated blood proteins leading to arterial damage, inflammation and comorbidities such as cardiovascular disease. Despite increased consumer interest in consuming foods that may help treat or prevent obesity and diabetes, effective countermeasures against metabolic diseases have yet to be established. Thus, food products that are capable of controlling parameters of metabolic diseases including blood glucose, insulin levels and food intake are in urgent need of investigation and identification. Dairy products are believed to hold this potential because of their functional physiological properties.

There have been many observational and long-term clinical studies showing that regular consumption of dairy products correlate with a better body composition and a lower incidence of obesity and type 2 diabetes. Studies have also found that dairy proteins are more satiating than other types of proteins, and that they are effective in lowering the increase in glycemic response after high GI food intake, but most studies have been done in isolated proteins. Hence, the role of dairy proteins, in their conventional food form reflecting usual intake, on food intake and glycemia and their interactions with these metabolic diseases is of interest.

From short-term studies done in our lab, the investigators have shown that dairy products can bring about benefits in glycemic control and food intake when consumed before or within ad libitum meals, which can be achieved by both insulin dependent and independent mechanisms. The investigators have shown that fluid milk products and yogurt improve post-meal glycemic excursions when consumed before or within an ad libitum meal by healthy young adults. Except the yogurt study conducted in our lab, there have been no other studies reporting the role of solid or semi-solid dairy products consumed before a meal, within a meal, immediately post-meal or as between meal snacks on glycemia and appetite control. Our study on yogurt showed that yogurts, especially those with high protein to carbohydrate ratio, reduced pre-meal glucose incremental areas under the curve. Further studies on solid and semi-solid dairy need to be conducted because milk, like other caloric beverages, lead to calorie accumulation if consumed before or with a meal even though it provides more nutrients, lowers post-meal blood glucose excursions and leads to greater post-meal satiety in young adults.

Moreover, the evidence appears to be relatively consistent with respect to a beneficial role of low-fat dairy products in the prevention of type 2 diabetes (T2D), however, the role of regular/high-fat dairy is less clear. A number of cross-sectional and prospective epidemiological studies have identified a positive association between the intake of dietary fat and the risk for development of either insulin resistance or T2D20. More research is needed to better understand the role of regular-fat dairy products on food intake as well as of glycemic control.

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
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy, non-smoking male and female participants aged 20-30 and 60-70 years old
  • Young adults with body mass index (BMI) of 18.5-24.9 kg/m2 (normal weight) and older adults with BMI between 18.5-29.9 kg/m2 (normal/overweight).

排除标准

  • Individuals on medication affecting appetite
  • Lactose-intolerant or allergic to dairy (including milk, yogurt, and cheese)
  • Breakfast skippers
  • Gastrointestinal problems
  • Individuals on an energy-restricted diet

结局指标

主要结局

Blood Glucose (Study 1, 2 and 3)

时间窗: Post-treatment and post-meal

Blood glucose (mmol/L) is measured by using finger prick capillary blood samples. Time frame and frequency vary for each study. Study 1: Baseline measure (0 minute) then every 15 minutes up to 120 min (post-treatment), 8 times; 140 to 170 min (post-meal) every 30 mintes, 2 times . A total of 10 times Study 2: Baseline measure (0 minute) then post-treatment every 15 minutes up to 90 minutes and last measure at 120 minutes. A total of 7 times. Study 3: Part 1: Baseline measure (0 minute) then every 15 minutes up to 30 minutes post-treatment, then 50 minutes and every 15 minutes until 125 minutes. A total of 9 times. Part 2: Baseline measure (0 minute) then at 15 post-treatment and, 35 and 50 minutes post-meal. A total of 4 times

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

G. Harvey Anderson

Professor

University of Toronto

研究点 (2)

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