Cholesterol Effects of Kori-tofu Proteins (CHOKO)

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.

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorders
• Intervention / Treatment: Other: Kori tofu bread; Other: Whey protein bread

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708 WG
      • Wageningen University & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Daily dose of Kori-tofu mixed in 3 slices of bread; Kori tofu as part of bread	Other: Kori tofu bread; 34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.
ACTIVE_COMPARATOR: 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	Other: Whey protein bread; Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wageningen University and Research
• Collaborators: Asahimatsu Foods
• Investigators: Principal Investigator: Diederik Esser, PhD, Wageningen University & Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 7, 2021
• Primary Completion (ACTUAL): December 7, 2021
• Study Completion (ACTUAL): December 7, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (ACTUAL): May 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Cholesterol; Kori tofu
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: NL75320.081.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No