Glucose IntoleranceKoProNCT04233281
Kori-tofu Proteins and Blood Glucose Response
A study testing Kori tofu and Whey protein in people with Glucose Intolerance, run by Wageningen University and Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- Kori tofu and Whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Jan 2020to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
About this study
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.
Read the 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
- Being tested
- Kori tofu, Whey protein
- Keywords
- Kori tofu, Glucose response, Pre-diabetics
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kori tofuOther
16.5 gram Kori-tofu mixed in a high carbohydrate test meal
Whey proteinOther
high carbohydrate test meal with whey protein, matched in macronutrient content
| Study group | Role | What they receive |
|---|---|---|
| Kori-tofu added to a carbohydrate rich meal | Experimental | Kori tofu as part of a carbohydrate rich meal Receives: Other: Kori tofu |
| Whey protein added to a carbohydrate rich meal | Active comparator | Whey protein as part of a carbohydrate rich meal Receives: Other: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: blood samples will be taken before and up to 3 hours after test meal consumption
Secondary outcomes (2)
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
Measured: blood samples will be taken before and up to 3 hours after teast meal consumption
change in postprandial glucose concentrations after food intake
measured by a continuous glucose monitoring device
Measured: 1.5 week in total to cover both test days and 3-4 days prior to the test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Jan 2020
- Primary completion28 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Asahimatsu Support BV
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, PhD, Principal investigator, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233281
- Sponsor's protocol ID
- NL71213.081.19
- Acronym
- KoPro
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kori-tofu Proteins and Blood Glucose Response
- ClinicalTrials.gov ID
- NCT04233281
- Acronym / sponsor ID
- KoPro / NL71213.081.19
- Conditions
- Glucose Intolerance
- Keywords
- Kori tofu, Glucose response, Pre-diabetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Asahimatsu Support BV
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kori-tofu added to a carbohydrate rich meal | Experimental | Other: Kori tofuKori tofu as part of a carbohydrate rich meal |
| Whey protein added to a carbohydrate rich meal | Active comparator | Other: Whey proteinWhey protein as part of a carbohydrate rich meal |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI >25 kg/m2
- Having veins suitable for blood sampling via a catheter
- Having one or more of the following criteria:
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kori tofu16.5 gram Kori-tofu mixed in a high carbohydrate test meal | Other | Kori-tofu added to a carbohydrate rich meal |
| Whey proteinhigh carbohydrate test meal with whey protein, matched in macronutrient content | Other | Whey protein added to a carbohydrate rich meal |
Primary outcome
change in blood glucose levels after a carbohydrate rich meal
Time frame: blood samples will be taken before and up to 3 hours after test meal consumption
postprandial test, determine glucose levels in blood samples collected before and after the test meal
2 secondary outcomes
change in blood insulin levels after a carbohydrate rich meal
Time frame: blood samples will be taken before and up to 3 hours after teast meal consumption
change in postprandial glucose concentrations after food intake
Time frame: 1.5 week in total to cover both test days and 3-4 days prior to the test day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diederik Esser, PhD principal investigator
Wageningen University and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kori tofu and Whey protein in people with Glucose Intolerance, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in blood glucose levels after a carbohydrate rich meal (time frame: blood samples will be taken before and up to 3 hours after test meal consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.