- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02228252
The Effect of Protein Quality and Time-factor by Consumption of a Pre-meal on Postprandial Lipemia in Subjects With the Metabolic Syndrome.
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aarhus C
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Aarhus, Aarhus C, Denmark, 8000
- Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Other Names:
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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.
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Other Names:
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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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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.
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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.
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Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Change in amino acids concentration from baseline to 30 min
Time Frame: Baseline (-30/-15 min), 30 min
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Baseline (-30/-15 min), 30 min
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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.
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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.
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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.
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S-paracetamol
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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.
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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.
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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.
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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.
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Prior to the pre meal (-30/-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal.
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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.
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Prior to the pre meal (-30/-15 min), and 120 and 360 min post main meal.
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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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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kjeld Hermansen, Prefessor, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERN-Premeal2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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