Kori-tofu Proteins and Blood Glucose Response

Not Applicable

Completed

• Conditions: Glucose Intolerance
• Interventions: Other: Whey protein; Other: Kori tofu

• Registration Number: NCT04233281
• Lead Sponsor: Wageningen University and Research

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.

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Primary Completion: 2020-02-28
• Status Verified: 2020-03
• Study Completion: 2020-03-01
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whey protein added to a carbohydrate rich meal	Whey protein	Whey protein as part of a carbohydrate rich meal
Kori-tofu added to a carbohydrate rich meal	Kori tofu	Kori tofu as part of a carbohydrate rich meal

Primary Outcome Measures

Name	Time	Method
change in blood glucose levels after a carbohydrate rich meal	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

Secondary Outcome Measures

Name	Time	Method
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	postprandial test, determine insulin levels in blood samples collected before and after the test meal
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	measured by a continuous glucose monitoring device

Trial Locations

Locations (1)

Stichting Wageningen Research; 🇳🇱 Wageningen, Gelderland, Netherlands