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

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ClinicalTrials.gov Identifier: NCT02228252
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : May 5, 2015
Sponsor:
Collaborators:
University of Aarhus
University of Copenhagen
Information provided by (Responsible Party):
Ann Bjørnshave, Aarhus University Hospital

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 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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Whey protein Other: Casein Other: Gluten protein Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Experimental: 20 g whey protein (-15 min)
20 g whey protein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 15 min prior to the main meal.
Other: Whey protein
Other Names:
  • Brand name: LACPRODAN® SP-9225 Instant
  • Lot nr.: D150214

Experimental: 20 g whey protein (-30 min)
20 g whey protein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 30 min prior to the main meal.
Other: Whey protein
Other Names:
  • Brand name: LACPRODAN® SP-9225 Instant
  • Lot nr.: D150214

Experimental: 20 g casein
20 g casein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 15 min prior to the main meal.
Other: Casein
Other Names:
  • Brand name: MIPRODAN 30
  • Lot nr.: 1594303

Experimental: 20 g gluten protein
21.5 g gluten protein dissolved in 200 milliliter (mL) Water. Consumed as a pre-meal 15 min prior to the main meal.
Other: Gluten protein
Other Name: Brand name: Reppe wheat gluten




Primary Outcome Measures :
  1. 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). [ Time Frame: 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. ]
  2. 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). [ Time Frame: Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal. ]

Secondary Outcome Measures :
  1. Glucose responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
  2. Insulin responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
  3. Glucagon responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
  4. Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
  5. Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]

Other Outcome Measures:
  1. Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
  2. Change in amino acids concentration from baseline to 30 min [ Time Frame: Baseline (-30/-15 min), 30 min ]
  3. Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -30-15 - 360 min) [ Time Frame: 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. ]
  4. Satiety measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
    S-paracetamol

  5. Responses of the inflammatory marker Rantes measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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. ]
  6. Responses of metabolomics measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) in plasma. [ Time Frame: Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal. ]
  7. Responses of metabolomics measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) in urine. [ Time Frame: Prior to the pre meal (-30/-15 min), and 120 and 360 min post main meal. ]
  8. Responses of satiety visual analog scale (VAS) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min) [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228252


Locations
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Denmark
Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
University of Copenhagen
Investigators
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Principal Investigator: Kjeld Hermansen, Prefessor Aarhus University Hospital

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Responsible Party: Ann Bjørnshave, PhD student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02228252     History of Changes
Other Study ID Numbers: CERN-Premeal2
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: August 2014
Keywords provided by Ann Bjørnshave, Aarhus University Hospital:
Proteins
Postprandial lipemia
Pre-meal
Metabolic syndrome
Additional relevant MeSH terms:
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Metabolic Syndrome
Hyperlipidemias
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action