Kori-tofu Proteins and Blood Glucose Response

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Kori-tofu Proteins and Blood Glucose Response

Conditions
-----------------
Glucose Intolerance

Intervention / Treatment
-----------------
* Other: Kori tofu
* Other: Whey protein


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kori-tofu added to a carbohydrate rich meal<br>Kori tofu as part of a carbohydrate rich meal | Other: Kori tofu<br>* 16.5 gram Kori-tofu mixed in a high carbohydrate test meal<br>|
| Active Comparator: Whey protein added to a carbohydrate rich meal<br>Whey protein as part of a carbohydrate rich meal | Other: Whey protein<br>* high carbohydrate test meal with whey protein, matched in macronutrient content<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | blood samples will be taken before and up to 3 hours after test meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1.5 week in total to cover both test days and 3-4 days prior to the test day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kori tofu, Glucose response, Pre-diabetics