Ignite Creation Date:
2024-05-06 @ 3:39 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02343471
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2015-01-16
Brief Title:
The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Whey Protein Postprandial Lipemia and Cardiovascular Disease Evaluation of the Effect of a Pre-meal of Whey Protein on Postprandial Lipiemia in Subjects With the Metabolic Syndrome and Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2015-01
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:
PREMEAL 3
Brief Summary:
Cardiovascular disease CVD is one of the most important and frequent causes of death Postprandial lipidemia PPL is an independent risk factor for CVD besides the traditional risk factors eg hypertension high LDL-cholesterol family disposition of CVD and type 2 diabetes T2D A high PPL is associated with an increased risk of myocardial infarction and stroke Reduction of increased PPL as a part of CVD prevention is therefore pivotal Especially in groups with increased risk of CVD like the metabolic syndrome MeS and T2D Identification of a simple diet-related method will possibly result in reduction of CVD in healthy as well as high-risk subjects
The aim of this project is to investigate the effect whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 ApoB48 in subjects with type 2 diabetes compared to healthy subjects Secondarily the aim is to study the responses of glucose insulin glucagon amino acids inflammatory markers incretins rate of gastric emptying and metabolomics Also satiety feeling will be measured
Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects compared to healthy subjects
The investigators research will hopefully contribute to a better understanding of how PPL can be modified in a simple manner It will promote innovation to the food industry for development and production of healthy food products which can be applied in the fight against CVD in the background population in general and high-risk people in particular Thus the results of this project can impart knowledge of great importance both to the national and international food industry as well as the healthcare systems
The aim of this project is to investigate the effect whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 ApoB48 in subjects with type 2 diabetes compared to healthy subjects Secondarily the aim is to study the responses of glucose insulin glucagon amino acids inflammatory markers incretins rate of gastric emptying and metabolomics Also satiety feeling will be measured
Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects compared to healthy subjects
The investigators research will hopefully contribute to a better understanding of how PPL can be modified in a simple manner It will promote innovation to the food industry for development and production of healthy food products which can be applied in the fight against CVD in the background population in general and high-risk people in particular Thus the results of this project can impart knowledge of great importance both to the national and international food industry as well as the healthcare systems
Detailed Description:
Using a randomised cross-over design 12 healthy subjects and 12 subjects with type 2 diabetes will consume a test meal prior to a fat-rich meal The test meals contain 2 different meal types on where whey protein is consumed as a pre-meal and another where water is the pre-meal In the second meal type whey protein is instead consumed as a part of the fat-rich meal Blood samples are collected before consumption of the pre-meal and after consumption of the fat-rich isocaloric meal during 360 minutes The fat-rich isocaloric meal is a breakfast containing 1043 kcal 15 E protein 65 E fat and 20 E carbohydrates The main-meal is composed of white bread rye bread butter cheese 45 salami egg bacon milk 15 fat and coffee decaffeinated and should be consumed over 15 min Visual Analog Scale VAS will be used for determination of subjective satiety feeling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None