Kori-tofu Proteins and Blood Glucose Response (KoPro)

Wageningen University and Research

Status

Completed

Conditions

Glucose Intolerance

Treatments

Other: Whey protein

Other: Kori tofu

Study type

Interventional

Funder types

Other

Identifiers

NCT04233281

NL71213.081.19

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No 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.