Lipid Metabolism DisordersCHOKONCT04896619
Cholesterol Effects of Kori-tofu Proteins
A study testing Kori tofu bread and Whey protein bread in people with Lipid Metabolism Disorders, 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 participants with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- Kori tofu bread and Whey protein bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Sep 2021to 7 Dec 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-70 years;
- BMI between 18.5-35 kg/m2;
- Total cholesterol levels >5 mmol/L or LDL >3 mmol/L
Who cannot join
- Use of medication/supplements/food items that may influence the study results, such as cholesterol lowering medication, Becel ProActiv (judged by our research physician);
- Total cholesterol levels >7 mmol/L;
- LDL cholesterol levels >5 mmol/L;
- 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;
Show all 13Show fewer
- Current smokers;
- Alcohol intake ≥4 glasses of alcoholic beverages per day;
- Pregnant, lactating or wishing to become pregnant in the period of the study (self-reported);
- Abuse of soft and/or hard drugs;
- Food allergies or intolerances for products that we use in the study;
- Participation in another clinical trial at the same time; NL75320.081.20 CHOKO Version number: 4, April 2021 15 of 34
- 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
Wageningen University & Research
Wageningen, Gelderland, 6708 WG
About this study
The study is a randomized, cross-over, double-blind, controlled trial in which participants with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference. Fasting total and LDL cholesterol will be determined at the start and end of each of the two intervention periods.
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 studies describe the effects of Kofi-tofu on health. In this study the aim is to investigate the effect of repetitive consumption of Kori-tofu on blood cholesterol levels and other lipid metabolism related measures, in research subjects with mildly elevated levels of cholesterol.
The primary objective is to assess the effect of repetitive consumption of Kori-tofu on blood total and LDL cholesterol levels. The secondary objective is to assess the effect of repetitive consumption of Kori-tofu on other markers of lipid metabolism, glucose metabolism and blood pressure.
The study is a randomized, cross-over, double-blind, controlled trial in which participants will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference (whey protein, soy oil and maltodextrin/cellulose). Research subjects will visit our research unit before and after each intervention period for a test day. During these test days fasting blood samples will be collected and blood pressure measurements will be performed.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- Kori tofu bread, Whey protein bread
- Keywords
- Kori tofu, Cholesterol
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kori tofu breadOther
34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.
Whey protein breadOther
Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread
| Study group | Role | What they receive |
|---|---|---|
| Daily dose of Kori-tofu mixed in 3 slices of bread | Experimental | Kori tofu as part of bread Receives: Other: Kori tofu bread |
| Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread | Active comparator | Whey protein, soy oil and maltodextrin as part of bread Receives: Other: Whey protein bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total cholesterol levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in LDL cholesterol levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary outcomes (10)
Change in HDL cholesterol levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in triglycerides levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in leptin levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in adiponectin levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in plasma insulin levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in HbA1c levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in fructosamine levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in glucose levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in systolic blood pressure levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in diastolic blood plessure levels
under fasting conditions
Measured: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start7 Sep 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Asahimatsu Foods
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
- Investigators
- Diederik Esser, PhD, Principal investigator, Wageningen University & Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896619
- Sponsor's protocol ID
- NL75320.081.20
- Acronym
- CHOKO
- Status last verified
- Dec 2021
- First submitted
- 10 May 2021
- Last updated
- 9 Dec 2021
- 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 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol Effects of Kori-tofu Proteins
- ClinicalTrials.gov ID
- NCT04896619
- Acronym / sponsor ID
- CHOKO / NL75320.081.20
- Conditions
- Lipid Metabolism Disorders
- Keywords
- Kori tofu, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Asahimatsu Foods
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 21 May 2021 (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 participants with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference. Fasting total and LDL cholesterol will be determined at the start and end of each of the two intervention periods.
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 studies describe the effects of Kofi-tofu on health. In this study the aim is to investigate the effect of repetitive consumption of Kori-tofu on blood cholesterol levels and other lipid metabolism related measures, in research subjects with mildly elevated levels of cholesterol.
The primary objective is to assess the effect of repetitive consumption of Kori-tofu on blood total and LDL cholesterol levels. The secondary objective is to assess the effect of repetitive consumption of Kori-tofu on other markers of lipid metabolism, glucose metabolism and blood pressure.
The study is a randomized, cross-over, double-blind, controlled trial in which participants will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5 grams or a matched reference (whey protein, soy oil and maltodextrin/cellulose). Research subjects will visit our research unit before and after each intervention period for a test day. During these test days fasting blood samples will be collected and blood pressure measurements will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily dose of Kori-tofu mixed in 3 slices of bread | Experimental | Other: Kori tofu breadKori tofu as part of bread |
| Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread | Active comparator | Other: Whey protein breadWhey protein, soy oil and maltodextrin as part of bread |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 40-70 years;
- BMI between 18.5-35 kg/m2;
- Total cholesterol levels >5 mmol/L or LDL >3 mmol/L
Key exclusion criteria (13 listed)
- Use of medication/supplements/food items that may influence the study results, such as cholesterol lowering medication, Becel ProActiv (judged by our research physician);
- Total cholesterol levels >7 mmol/L;
- LDL cholesterol levels >5 mmol/L;
- 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;
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 tofu bread34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread. | Other | Daily dose of Kori-tofu mixed in 3 slices of bread |
| Whey protein breadMatched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread | Other | Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread |
Primary outcome
Change in total cholesterol levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
under fasting conditions
Change in LDL cholesterol levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
under fasting conditions
10 secondary outcomes
Change in HDL cholesterol levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in triglycerides levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in leptin levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in adiponectin levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in plasma insulin levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in HbA1c levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in fructosamine levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in glucose levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in systolic blood pressure levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Change in diastolic blood plessure levels
Time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
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 9 Dec 2021.
- 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 & 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 bread and Whey protein bread in people with Lipid Metabolism Disorders, 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 3 inclusion and 13 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 9 Dec 2021. 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 total cholesterol levels (time frame: 0 weeks, 4 weeks, 8 weeks and 12 weeks). The study lists 2 primary outcomes in all. 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 9 Dec 2021.