Kori-tofu Proteins and Blood Glucose Response

NCT ID: NCT04233281

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2020-03-01

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.

Conditions

Glucose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Kori-tofu added to a carbohydrate rich meal

Kori tofu as part of a carbohydrate rich meal

Group Type: EXPERIMENTAL

Kori tofu

Intervention Type: OTHER

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

Whey protein added to a carbohydrate rich meal

Whey protein as part of a carbohydrate rich meal

Group Type: ACTIVE_COMPARATOR

Whey protein

Intervention Type: OTHER

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

Interventions

Kori tofu

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

Intervention Type: OTHER

Whey protein

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asahimatsu Support BV

UNKNOWN

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

Project leader clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diederik Esser, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University and Research

Locations

Stichting Wageningen Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL71213.081.19

Identifier Type: -

Identifier Source: org_study_id