The Effect of Protein Quality and Time-factor by Consumption of a Pre-meal on Postprandial Lipemia in Subjects With the Metabolic Syndrome.

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228252
• Other study ID #: CERN-Premeal2
• Status: Completed
• Phase: N/A
• First received: August 27, 2014
• Last updated: May 4, 2015
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2014
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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 e.g. 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 of protein quality and the time factor of protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48). 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 compared to casein protein and gluten protein consumed 15 minutes prior to the meal and whey protein consumed 30 minutes prior to the meal in subjects with MeS.

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.

Description:

Using a randomised, cross-over design 20 subjects with MeS will consume a test meal prior to a fat-rich meal. The test meals contain three different amounts of whey protein. 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 (1.5 % fat) and coffee (decaffeinated) and should be consumed over 15 min. Visual Analog Scale (VAS) will be used for determination of subjective satiety feeling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Central obesity (female > 80 cm; male > 94 cm) with two of the following parameters:

• Fasting triglycerides > 1.7 mmol/L

• Fasting HDL-cholesterol < 1.03 mmol/L (female) or <1.29 mmol/L (male)

• Blood pressure = 130/85 mmHg

• Fasting plasma glucose = 5.6 mmol/L Subjects who are in medical treatment with lipid and/or blood pressure-lowering habitual treatment can participate provided that the treatment is stable throughout the trial.

Exclusion Criteria:

• Type 1 diabetes

• Type 2 diabetes (HbA1c = 48 mmol/L)

• Fasting plasma triglycerides > 5.0 mmol/L

• Blood pressure > 160/100 mmHg

• Cardiovascular, liver, kidney or metabolic disease

• Corticosteroid treatment

• Pregnancy or lactation

• Alcohol or drug abuse

• Legal incapacity

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Whey protein

• Casein

• Gluten protein

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Other	Change in amino acids concentration from baseline to 30 min		Baseline (-30/-15 min), 30 min	No
Other	Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -30-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Other	Satiety measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)	S-paracetamol	Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Other	Responses of the inflammatory marker Rantes measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Other	Responses of metabolomics measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) in plasma.		Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.	No
Other	Responses of metabolomics measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) in urine.		Prior to the pre meal (-30/-15 min), and 120 and 360 min post main meal.	No
Other	Responses of satiety visual analog scale (VAS) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 and 360 min post main meal	No
Primary	Effect on triglyceride response of whey protein as pre-meal after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min).		Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.	No
Primary	Effect on apolipoprotein B48 of whey protein as pre-meal after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min).		Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.	No
Secondary	Glucose responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Secondary	Insulin responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Secondary	Glucagon responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Secondary	Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No
Secondary	Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)		Prior to the pre meal (-30, -25) -15 min, (-10 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.	No