Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896619
Status:
COMPLETED
Last Update Posted:
2021-12-09
First Post:
2021-05-10
Brief Title:
Cholesterol Effects of Kori-tofu Proteins
Sponsor:
Wageningen University and Research
Organization:
Wageningen University and Research
Study Overview
Official Title:
Cholesterol Effects of Kori-tofu Proteins
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOKO
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 eg 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 345 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 eg 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 345 grams or a matched reference whey protein soy oil and maltodextrincellulose 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
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 eg 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 345 grams or a matched reference whey protein soy oil and maltodextrincellulose 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None