Kori-tofu Proteins and Blood Glucose Response

Glucose Intolerance Clinical Trial

— KoPro  

Official title:

Kori-tofu Proteins and Blood Glucose Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04233281
• Other study ID #: NL71213.081.19
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 1, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Other:
• Kori tofu
16.5 gram Kori-tofu mixed in a high carbohydrate test meal
• Whey protein
high carbohydrate test meal with whey protein, matched in macronutrient content

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University and Research	Asahimatsu Support BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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