Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340412
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-06
Brief Title:
Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The aim of the study is to investigate the effects of milk fat globule membrane MFGM content and intactness on postprandial metabolic response to a high-fat meal in humans
The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal
The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal
Detailed Description:
The subjects will be invited for four visits in total one screening visit and three test days separated by a one-week washout period At the test days subjects will consume two high-fat meals composed of milk fat with intact MFGM destroyed MFGM and without MFGM respectively The first meal will be consumed as breakfast and the second meal will be consumed as lunch Test meals will be isocaloric and with similar macronutrient composition The meal will consist of a sandwich with a butter-like dairy product
The three trial days will be completely alike besides the interventions
Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize
The participants will have one intravenous iv access placed in the elbow on the three trial days where blood samples will be collected at 15 30 60 90 120 150 and 180 min after each test meal breakfast and lunch
Immediately after consuming each of the two test meals the subjects will take 1500mg paracetamol to determine ventricular emptying rate using the acetaminophen test After this the subjects can lay in the bed and watch TV iPad or work on their laptop
Before and every hour after consumption of the test meals the subjects will be asked to fill out an appetite questionnaire visual analogue scale At the end of the day the participants will be offered an ad libitum meal to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal
An one-way mixed model of linear regression will be used to compare postprandial area under the curve ventricular emptying and ad libitum food intake between the three test days Secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements
Based on the results from a previous study that investigated the effects of the fat and protein structure in dairy products on postprandial triglycerides 20 the investigators will need 11 subjects to detect a 15 decrease in postprandial triglyceride AUC α005 β080 To account for potential missing values 12 subjects will be included in total
The three trial days will be completely alike besides the interventions
Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize
The participants will have one intravenous iv access placed in the elbow on the three trial days where blood samples will be collected at 15 30 60 90 120 150 and 180 min after each test meal breakfast and lunch
Immediately after consuming each of the two test meals the subjects will take 1500mg paracetamol to determine ventricular emptying rate using the acetaminophen test After this the subjects can lay in the bed and watch TV iPad or work on their laptop
Before and every hour after consumption of the test meals the subjects will be asked to fill out an appetite questionnaire visual analogue scale At the end of the day the participants will be offered an ad libitum meal to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal
An one-way mixed model of linear regression will be used to compare postprandial area under the curve ventricular emptying and ad libitum food intake between the three test days Secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements
Based on the results from a previous study that investigated the effects of the fat and protein structure in dairy products on postprandial triglycerides 20 the investigators will need 11 subjects to detect a 15 decrease in postprandial triglyceride AUC α005 β080 To account for potential missing values 12 subjects will be included in total
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