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Kori-tofu Proteins and Blood Glucose Response (KoPro)

Primary Purpose

Glucose Intolerance

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Kori tofu

Whey protein

About this trial

This is an interventional treatment trial for Glucose Intolerance focused on measuring Kori tofu, Glucose response, Pre-diabetics

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stichting Wageningen Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kori-tofu added to a carbohydrate rich meal

Whey protein added to a carbohydrate rich meal

Arm Description

Kori tofu as part of a carbohydrate rich meal

Whey protein as part of a carbohydrate rich meal

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

change in postprandial glucose concentrations after food intake

measured by a continuous glucose monitoring device

Full Information

NCT ID

NCT04233281

First Posted

January 14, 2020

Last Updated

March 25, 2020

Sponsor

Wageningen University and Research

Collaborators

Asahimatsu Support BV

1. Study Identification

Unique Protocol Identification Number

NCT04233281

Brief Title

Kori-tofu Proteins and Blood Glucose Response

Acronym

KoPro

Official Title

Kori-tofu Proteins and Blood Glucose Response

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 6, 2020 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wageningen University and Research

Collaborators

Asahimatsu Support BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glucose Intolerance

Keywords

Kori tofu, Glucose response, Pre-diabetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kori-tofu added to a carbohydrate rich meal

Arm Type

Experimental

Arm Description

Kori tofu as part of a carbohydrate rich meal

Arm Title

Whey protein added to a carbohydrate rich meal

Arm Type

Active Comparator

Arm Description

Whey protein as part of a carbohydrate rich meal

Intervention Type

Other

Intervention Name(s)

Kori tofu

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Whey protein

Intervention Description

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

Primary Outcome Measure Information:

Title

change in blood glucose levels after a carbohydrate rich meal

Description

postprandial test, determine glucose levels in blood samples collected before and after the test meal

Time Frame

blood samples will be taken before and up to 3 hours after test meal consumption

Secondary Outcome Measure Information:

Title

change in blood insulin levels after a carbohydrate rich meal

Description

postprandial test, determine insulin levels in blood samples collected before and after the test meal

Time Frame

blood samples will be taken before and up to 3 hours after teast meal consumption

Title

change in postprandial glucose concentrations after food intake

Description

measured by a continuous glucose monitoring device

Time Frame

1.5 week in total to cover both test days and 3-4 days prior to the test day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diederik Esser, PhD

Organizational Affiliation

Wageningen University and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stichting Wageningen Research

City

Wageningen

State/Province

Gelderland

ZIP/Postal Code

6708 WG

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

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Kori-tofu Proteins and Blood Glucose Response

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