Clinical trial NCT04896619: Cholesterol Effects of Kori-tofu Proteins
Official title: Cholesterol Effects of Kori-tofu Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Metabolism Disorders
Keywords: Kori tofu
Cholesterol
Lead sponsor: Wageningen University and Research
Sponsor class: OTHER
Collaborators: name: Asahimatsu Foods
First posted: 2021-05-21
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
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 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.

Eligibility criteria: Inclusion Criteria:

* Age between 40-70 years;
* BMI between 18.5-35 kg/m2;
* Total cholesterol levels \>5 mmol/L or LDL \>3 mmol/L

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Change in total cholesterol levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in LDL cholesterol levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary outcomes:
measure: Change in HDL cholesterol levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in triglycerides levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in leptin levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in adiponectin levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in plasma insulin levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in HbA1c levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in fructosamine levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in glucose levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in systolic blood pressure levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Change in diastolic blood plessure levels
timeFrame: 0 weeks, 4 weeks, 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
affiliation: Wageningen University & Research
name: Diederik Esser, PhD
role: PRINCIPAL_INVESTIGATOR
References: