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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
16.5 gram Kori-tofu mixed in a high carbohydrate test meal
high carbohydrate test meal with whey protein, matched in macronutrient content
Stichting Wageningen Research
Wageningen, Gelderland, Netherlands
change in blood glucose levels after a carbohydrate rich meal
postprandial test, determine glucose levels in blood samples collected before and after the test meal
Time frame: blood samples will be taken before and up to 3 hours after test meal consumption
change in blood insulin levels after a carbohydrate rich meal
postprandial test, determine insulin levels in blood samples collected before and after the test meal
Time frame: blood samples will be taken before and up to 3 hours after teast meal consumption
change in postprandial glucose concentrations after food intake
measured by a continuous glucose monitoring device
Time frame: 1.5 week in total to cover both test days and 3-4 days prior to the test day
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