Dose-response Effect of Whey Protein Consumed as Pre-meal on Postprandial Lipaemia in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hyperlipidemias; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Whey protein
Intervention type(s): Other
Intervention description(s): Different amounts of whey protein dissolved in 200 mL water.
Other intervention name(s): Brand name: LACPRODAN® SP-9225 Instant; Lot nr.: D150214
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Whey protein; Postprandial lipaemia; Pre-meal; Metabolic syndrome