Skip to main content
OpenTrials
Completed

NCT Number: NCT04233281

Kori-tofu Proteins and Blood Glucose Response

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kori tofu

Other

16.5 gram Kori-tofu mixed in a high carbohydrate test meal

Whey Protein

Other

high carbohydrate test meal with whey protein, matched in macronutrient content

Primary outcomes

  1. change in blood glucose levels after a carbohydrate rich meal

    Time frame: 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 outcomes

  1. change in blood insulin levels after a carbohydrate rich meal

    Time frame: 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

  2. change in postprandial glucose concentrations after food intake

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wageningen University and Research

Other

Collaborators

  • Asahimatsu Support BV

Registry information

Acronym: KoPro

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.