Kori-tofu Proteins and Blood Glucose Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- change in blood glucose levels after a carbohydrate rich meal
研究概览
简要总结
The study is a randomized, cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions with a minimum of 1 week between visits. During each visit, participants will receive a carbohydrate rich test-meal with Kori-tofu (protein) or whey protein. The two meals will be given in randomized order and blood will be collected via a catheter before and up to 3 hours after consumption of the test-meal. Study participants will also wear continuous glucose meters during the trial. They will receive a standardized evening meal prior to each study day and are asked not to drink alcohol or perform heavy exercise the day before. After each test day participants are offered a meal.
详细描述
There are several types of tofu, an example of a specific type of tofu is called Kori-tofu. Kori-tofu literally means frozen tofu. The production process of Kori-tofu leads to the formation of a higher high molecular weight fraction (HMF) content of the soy proteins. Several clinical studies describe the effects of Kofi-tofu on health. In this study, the aim is to investigate whether Kori-tofu protein affects postprandial blood glucose concentrations in participants with an impaired glucose tolerance.
The primary objective is to investigate whether Kori-tofu protein affects postprandial blood glucose concentrations, when administered as a part of an ordinary high carbohydrate meal. The secondary objective is to investigate whether Kori-tofu protein affects postprandial insulin concentrations.
The study is a randomized, cross-over, double blind, controlled trial in which study participants will visit the research facility on two occasions under fasting conditions. Subjects will receive two different carbohydrate-rich meals, either with added Kori-tofu or whey protein, with a washout period of one week. Blood will be collected via a catheter before and up-to 3 hours after consumption of the test-meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >25 kg/m2
- •Having veins suitable for blood sampling via a catheter
- •Having one or more of the following criteria:
- •HbA1c> 6%
- •fasting glucose >6.1mmol/L
- •two-hour glucose levels >7.8 mmol/L on the 75-g oral glucose tolerance test.
排除标准
- •History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
- •History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
- •Kidney dysfunction (self-reported)
- •Use of medication/supplements that may influence the study results, such as med-icines known to interfere with glucose homeostasis (judged by our study doctor)
- •Anaemia (Hb values <7.5 for women and <8.5 for men)
- •Reported slimming, medically prescribed or other extreme diets
- •Reported weight loss or weight gain of > 5 kg in the month prior to pre-study screening
- •Not willing to give up blood donation during the study
- •Current smokers
- •Alcohol intake ≥4 glasses of alcoholic beverages per day
- •Abuse of illicit drugs
- •Food allergies for products that we use in the study
- •Participation in another clinical trial at the same time
- •Being an employee of the Food, Health & Consumer Research group of Wageningen Food & Biobased Research.
结局指标
主要结局
change in blood glucose levels after a carbohydrate rich meal
时间窗: blood samples will be taken before and up to 3 hours after test meal consumption
postprandial test, determine glucose levels in blood samples collected before and after the test meal
次要结局
- change in blood insulin levels after a carbohydrate rich meal(blood samples will be taken before and up to 3 hours after teast meal consumption)
- change in postprandial glucose concentrations after food intake(1.5 week in total to cover both test days and 3-4 days prior to the test day)
研究者
Diederik Esser
Project leader clinical trials
Wageningen University and Research