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Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Whey protein
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Whey protein, Postprandial lipaemia, Pre-meal, Metabolic syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

0g whey protein

10g whey protein

20g whey protein

Arm Description

0g whey protein dissolved in 200 milliliter (mL) water.

10g whey protein dissolved in 200 milliliter (mL) water.

20g whey protein dissolved in 200 milliliter (mL) water.

Outcomes

Primary Outcome Measures

Dose-response of whey protein as pre-meal on triglycerides after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Dose-response of whey protein as pre-meal on apolipoprotein B48 after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)

Secondary Outcome Measures

Glucose responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Insulin responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Glucagon responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)

Full Information

First Posted
March 10, 2014
Last Updated
July 18, 2014
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02087124
Brief Title
Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome
Official Title
Whey Protein, Postprandial Lipaemia and Cardiovascular Disease: Evaluation of the Effect of a Pre-meal of Whey Protein on Postprandial Lipaemia in Persons With the Metabolic Syndrome and Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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 if there is a dose-response effect of whey 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 (10 or 20g) consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more and in a dose-dependent way compared to placebo (water) consumed 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Whey protein, Postprandial lipaemia, Pre-meal, Metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0g whey protein
Arm Type
Experimental
Arm Description
0g whey protein dissolved in 200 milliliter (mL) water.
Arm Title
10g whey protein
Arm Type
Experimental
Arm Description
10g whey protein dissolved in 200 milliliter (mL) water.
Arm Title
20g whey protein
Arm Type
Experimental
Arm Description
20g whey protein dissolved in 200 milliliter (mL) water.
Intervention Type
Other
Intervention Name(s)
Whey protein
Other Intervention Name(s)
Brand name: LACPRODAN® SP-9225 Instant, Lot nr.: D150214
Intervention Description
Different amounts of whey protein dissolved in 200 mL water.
Primary Outcome Measure Information:
Title
Dose-response of whey protein as pre-meal on triglycerides after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.
Title
Dose-response of whey protein as pre-meal on apolipoprotein B48 after a high-fat meal in subjects with the metabolic syndrome measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.
Secondary Outcome Measure Information:
Title
Glucose responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Title
Insulin responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Title
Glucagon responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Title
Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Title
Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal.
Other Pre-specified Outcome Measures:
Title
Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 180, 240 and 360 min post main meal.
Title
Satiety measured as incremental Area Under the Curve (AUC -15 - 360 min)
Description
S-paracetamol
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 180 and 240min post main meal.
Title
Change in amino acids concentration from baseline to 30 min
Time Frame
Baseline (-15 min), 30 min
Title
Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal.
Title
Responses of the inflammatory marker Rantes measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 15, 30, 60, 90, 120, 180 240 and 360 min post main meal.
Title
Responses of metabolomics measured as incremental Area Under the Curve (AUC -15 - 360 min) in plasma
Time Frame
Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.
Title
Responses of metabolomics measured as incremental Area Under the Curve (AUC -15 - 360 min) in urine.
Time Frame
Prior to the pre meal (-15 min), and 120 and 360 min post main meal.
Title
Responses of satiety visual analog scale (VAS) measured as incremental Area Under the Curve (AUC -15 - 360 min)
Time Frame
Prior to the main meal (0 min) and 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 and 360 min post main meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Hermansen, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Aarhus C.
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome

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