Cholesterol Effects of Kori-tofu Proteins

NCT ID: NCT04896619

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-07
• Study Completion Date: 2021-12-07

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.

Conditions

Lipid Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Daily dose of Kori-tofu mixed in 3 slices of bread

Kori tofu as part of bread

Group Type: EXPERIMENTAL

Kori tofu bread

Intervention Type: OTHER

34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.

Daily dose of whey protein, soy oil and maltodextrin mixed in 3 slices of bread

Whey protein, soy oil and maltodextrin as part of bread

Group Type: ACTIVE_COMPARATOR

Whey protein bread

Intervention Type: OTHER

Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread

Interventions

Kori tofu bread

34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.

Intervention Type: OTHER

Whey protein bread

Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asahimatsu Foods

UNKNOWN

Sponsor Role: collaborator

Wageningen University and Research

OTHER

Sponsor Role: lead

Responsible Party

Diederik Esser

Project leader clinical trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diederik Esser, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University & Research

Locations

Wageningen University & Research

Wageningen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL75320.081.20

Identifier Type: -

Identifier Source: org_study_id