Clinical trial NCT04233281: Kori-tofu Proteins and Blood Glucose Response
Official title: Kori-tofu Proteins and Blood Glucose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Keywords: Kori tofu
Glucose response
Pre-diabetics
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Asahimatsu Support BV
First posted: 2020-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in blood glucose levels after a carbohydrate rich meal
timeFrame: blood samples will be taken before and up to 3 hours after test meal consumption
Secondary outcomes:
measure: change in blood insulin levels after a carbohydrate rich meal
timeFrame: blood samples will be taken before and up to 3 hours after teast meal consumption
measure: change in postprandial glucose concentrations after food intake
timeFrame: 1.5 week in total to cover both test days and 3-4 days prior to the test day
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Stichting Wageningen Research
state: Gelderland
Study officials:
affiliation: Wageningen University and Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References: