The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes
Condition: Healthy; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias
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 the effect whey protein consumed as pre-meal prior
      to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects
      with type 2 diabetes compared to healthy subjects. 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 in type 2 diabetic subjects
      compared to healthy subjects.

      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 12 healthy subjects and 12 subjects with type 2
      diabetes will consume a test meal prior to a fat-rich meal. The test meals contain 2
      different meal types; on where whey protein is consumed as a pre-meal and another where water
      is the pre-meal. In the second meal type whey protein is instead consumed as a part of the
      fat-rich meal. 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): 20 g whey protein
Intervention type(s): Dietary Supplement
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 proteins; Postprandial lipemia; Pre-meal; Type 2 diabetes