Cholesterol Effects of Kori-tofu Proteins

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cholesterol Effects of Kori-tofu Proteins

Conditions
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Lipid Metabolism Disorders

Intervention / Treatment
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* Other: Kori tofu bread
* Other: Whey protein bread


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily dose of Kori-tofu mixed in 3 slices of bread<br>Kori tofu as part of bread | Other: Kori tofu bread<br>* 34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.<br>|
| Active Comparator: Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread<br>Whey protein, soy oil and maltodextrin as part of bread | Other: Whey protein bread<br>* Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total cholesterol levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in LDL cholesterol levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HDL cholesterol levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in triglycerides levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in leptin levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in adiponectin levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in plasma insulin levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in HbA1c levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in fructosamine levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in glucose levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in systolic blood pressure levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 
| Change in diastolic blood plessure levels | under fasting conditions | 0 weeks, 4 weeks, 8 weeks and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, Kori tofu