Kori-tofu Proteins and Blood Glucose Response (KoPro)

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.

Study Overview

• Status: Completed
• Conditions: Glucose Intolerance
• Intervention / Treatment: Other: Kori tofu; Other: Whey protein

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Stichting Wageningen Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Asahimatsu Support BV

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Glucose response; Kori tofu; Pre-diabetics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: NL71213.081.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No