kori-tofu proteins and blood glucose response

Conditions: Glucose Intolerance

Summary: 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.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: kori tofu glucose response pre-diabetics