Effects of Functional Ingredients in an Acute Metabolic Challenge Context
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary
      increase, triggering a wave of oxidative stress due to the appearance of excess free radicals
      in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated
      with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial
      changes in different circulating biomarkers are potential predictors of cardiometabolic risk.
      In addition to the possibility of evaluating acute variations in metabolic risk markers in
      response to different types of fat, the metabolic challenge approach may serve as a
      challenge-meal background in order to reveal possible beneficial effects of specific food
      ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including
      endotoxemia, will be assessed postprandially in search for beneficial actions of particular
      functional food ingredients consumed in combination with a high-fat meal.
    

Detailed description: 
      The study will be carried out in a group of healthy mature subjects with overweight and
      normal fasting blood glucose values.

      A randomized crossover design will be followed, in which the postprandial metabolic responses
      to a high fat breakfast (HF) will be compared with those registered after an identical
      breakfast containing a functional ("active") ingredient. Each meal will be tested in an
      independent experimental session. Experimental sessions will take place with1 week interval.
      The study will be carried out at the Food for Health Laboratory, Food for Health Science
      Centre - Lund University (Medicon Village, Lund).

      The volunteers will consume the challenge HF alone and with 4 active ingredients, i.e. each
      volunteer will undergo five experimental sessions. Additionally, the plan contemplates an
      initial information visit that includes the screening of fasting blood glucose. In total,
      each volunteer completing the study will pay six visits to the Food for Health Laboratory.

      Based on the results from the above-described phase, a second step of the study will focus on
      the impact of the order of consumption -i.e. "active ingredient" before HF and vice versa on
      cardiometabolic risk outcomes, as a way to optimize putative protective actions.
    

Intervention name(s): Reference breakfast; Active Ingredient 1; Active Ingredient 2; Active Ingredient 3; Active Ingredient 4
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): A high fat, high calorie breakfast; A high fat, high calorie breakfast including the Active Ingredient 1; A high fat, high calorie breakfast including the Active Ingredient 2; A high fat, high calorie breakfast including the Active Ingredient 3; A high fat, high calorie breakfast including the Active Ingredient 4
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 diabetes risk; cardiovascular disease risk