Status:
COMPLETED
Cholesterol Effects of Kori-tofu Proteins
Lead Sponsor:
Wageningen University and Research
Collaborating Sponsors:
Asahimatsu Foods
Conditions:
Lipid Metabolism Disorders
Eligibility:
All Genders
40-70 years
Phase:
NA
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)...
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 highe...
Eligibility Criteria
Inclusion
- Age between 40-70 years;
- BMI between 18.5-35 kg/m2;
- Total cholesterol levels \>5 mmol/L or LDL \>3 mmol/L
Exclusion
- 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.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04896619
Start Date
September 7 2021
End Date
December 7 2021
Last Update
December 9 2021
Active Locations (1)
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1
Wageningen University & Research
Wageningen, Gelderland, Netherlands, 6708 WG