Cholesterol Effects of Kori-tofu Proteins

Lipid Metabolism Disorders Clinical Trial

— CHOKO  

Official title:

Cholesterol Effects of Kori-tofu Proteins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896619
• Other study ID #: NL75320.081.20
• Status: Completed
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: December 2021
• Source: Wageningen University and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Other:
• Kori tofu bread
34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.
• Whey protein bread
Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread

Locations

Country	Name	City	State
Netherlands	Wageningen University & Research	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University and Research	Asahimatsu Foods

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total cholesterol levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Primary	Change in LDL cholesterol levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in HDL cholesterol levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in triglycerides levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in leptin levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in adiponectin levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in plasma insulin levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in HbA1c levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in fructosamine levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in glucose levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in systolic blood pressure levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Change in diastolic blood plessure levels	under fasting conditions	0 weeks, 4 weeks, 8 weeks and 12 weeks