Effect of Milk Ingredients on Glucose Regulation and Inflammation in Overweight Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in fasting blood glucose
研究概览
简要总结
Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy and its components are known to exert beneficial effects on postprandial hyperglycemia. This study investigates if dairy, normal and enriched, can reduce chronic inflammation via improvement in glucose regulation.
Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose regulation and postprandial inflammation with the effect of a standard milk drink, within a population of overweight, apparently healthy subjects.
Study design: The study is designed as a double-blind randomized placebo-controlled parallel trial during 7 weeks, during which the test and reference products will be consumed at home.
Main study parameters/endpoints: The difference in absolute change in fasting blood plasma concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the treatment period, between subjects consuming the test and reference product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 28-35 kg/m2
- •Waist circumference >102 cm
- •Healthy as assessed by the NIZO lifestyle and health questionnaire and results of the pre-study safety laboratory tests.
- •Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
- •Habitual consumption of dairy products as assessed by dietary questionnaire
- •Voluntary participation
- •Having given written informed consent
- •Willing to comply with study procedures
- •Access to internet
- •Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years.
- •Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned
排除标准
- •Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- •Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous or inhalatory administration of substances
- •Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal strictures
- •Medical drug use; antibiotics, laxatives, glucose lowering drugs, insulin; all medication with an inflammation inhibiting effect (e.g. NSAIDS, corticosteroids) and/or an effect on blood coagulation (e.g. coumarins, inhibitors of thrombin or factor Xa, acetylsalicylic acid, antidepressants from the group of serotonin reabsorption inhibitors, tranexamin acid)
- •Mental status that is incompatible with the proper conduct of the study
- •A self-reported reported food allergy or sensitivity (wheat, milk, lactose, eggs, nuts, etc)
- •Alcohol consumption > 28 units/week and 4/day
- •Exercise > 3 hours/week
- •Smoking >20 cigarettes/day
- •Reported unexplained weight loss or weight gain of > 3 kg in the month prior to pre-study screening
- •Reported slimming or medically prescribed diet
- •Reported vegan or macrobiotic life-style
- •Recent blood donation (<1 month prior to Day 01 of the study)
- •Not willing or afraid to give up blood donation during the study
- •Personnel of NIZO food research or Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives
- •Not having a general practitioner
- •Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner
结局指标
主要结局
change in fasting blood glucose
时间窗: baseline and 7 weeks
change in fasting plasma interleukin-6 (IL-6)
时间窗: baseline and 7 weeks
次要结局
- postprandial area under the curve for plasma glucose(7 weeks)
- change in fasting insulin(7 weeks)
- postprandial area under the curve for plasma IL-6(7 weeks)
- postprandial area under the curve for plasma insulin(7 weeks)
研究者
Alwine Kardinaal
Project Manager Health
NIZO Food Research