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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will be the change in blood glucose levels after
consumption of the test meal
Secondary outcome
The secondary study parameter will be the change in blood insulin levels after
consumption of the test meal
Background summary
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. We aim to investigate in participant with an
impaired glucose tolerance, whether Kori-tofu protein affects postprandial
blood glucose concentrations, when administered as a part of an ordinary high
carbohydrate meal.
Study objective
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 blood insulin concentrations.
Study design
We will test two different test meals: a carbohydrate rich meal with Kofi-tofu
(protein) and a carbohydrate rich meal with whey protein as reference. Meals
will be matched in macronutrient composition, volume and taste (as much as
possible). In order to compare glycaemic responses of both meals, we will
conduct a double-blind, randomised, crossover trial. 24 study participants with
an impaired glucose tolerance will visit the research facility on two separate
occasions, with a minimum of 1 week between visits. After inserting a cannula,
a baseline blood sample will be collected. Participants will thereafter consume
one of the test meals. Postprandial blood samples will be collected from the
cannula at multiple time points up to 3 hours after consumption of the meal.
Study participants will also wear continues glucose meters during the trial.
Intervention
A carbohydrate rich meal with Kofi-tofu (protein) and a carbohydrate rich meal
with whey protein as reference (matched with lipid and carbohydrate content).
Study burden and risks
There are minor risks for the participants of this study. There are no direct
benefits for the participants. All ingredients are suitable for human
consumption and commercially available. The total amount of blood collected
during the study (214ml) is not expected to cause any problems. Blood
collection via a catheter may cause some discomfort and a bruise. Study
subjects that will participate in the study will invest approximately 13 hours
during the trial and need to visit the research facility on five occasions.
Karmelitessenlaan 19
Arnhem 6816 PK
NL
Karmelitessenlaan 19
Arnhem 6816 PK
NL
Listed location countries
Age
Inclusion criteria
Age 50-75yrs
BMI >25 kg/m2
Having veins suitable for blood sampling via a catheter
Having one or more of the following criteria:
o HbA1c> 6%
o fasting glucose >6.1mmol/L
o 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 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
Wa-geningen Food & Biobased Research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | het traject loopt |
| CCMO | NL71213.081.19 |