Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products
Condition: Glucose, High Blood; Inflammatory Response; Oxidative Stress; Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      The composition of a food or a meal consumed plays an important role in the rate of
      postprandial endocrine and metabolic response, especially if high in fats, sugars and total
      energy content and a reduction in its entity is related to beneficial effects towards the
      prevention of several chronical diseases. The physiological postprandial response depends on
      several factors, both intrinsic, such as natural characteristic of food, and extrinsic, such
      as the way in which food is processed. This study aims at investigating postprandial
      hormonal, metabolic, oxidative stress, inflammation and endotoxaemia responses after the
      consumption of different commercial confectionary products made with different reformulation
      (ingredients and/or processing techniques).The principal scope of the study is to evaluate
      the impact of the reformulation of different snacks on postprandial responses. The
      investigators therefore designed a randomized controlled crossover trial, in which 15 healthy
      volunteers will consume different isocaloric confectionary products (snacks) and their
      related reformulation (total products number = 6) and a reference snack. Venous blood samples
      will be collected until 4-h after meal consumption. In order to evaluate postprandial
      hormonal, metabolic, oxidative stress, inflammation and endotoxaemia responses several
      markers will be evaluate:

        -  metabolic substrates: glucose; Triglycerides and NEFA;

        -  hormones: insulin; c-peptide; GLP-1, GIP, leptin, ghrelin, PYY;

        -  markers of inflammation: IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1;

        -  markers of oxidative stress and antioxidant capacity: GSH, FRAP;

        -  endotoxaemia: lipopolysaccharides (LPS).

      These results will contribute to a detailed evaluation of the effects of reformulation on
      physiological events after meal consumption, leading to clarify if these variations in
      ingredients and/or processing techniques can modify postprandial responses, making them more
      similar to those originated from the reference snack.
    

Detailed description: 
      Meal consumption, especially if high in fats, sugars and total energy content, leads to a
      transient rise in blood glucose and lipids. The extent of glycemic and lipidemic postprandial
      responses have been linked to the progression of cardiovascular and other chronic
      degenerative diseases, such as type 2 diabetes and Alzheimer through a substantial increase
      in oxidative stress, systemic inflammation, and endothelial dysfunction. In addition, some
      studies have shown that consuming a high fat meal is associated with a postprandial increase
      in plasma and serum endotoxin concentrations in humans. LPS, lipopolysaccharide, is
      considered a major predisposing factor for inflammation-associated diseases such as
      atherosclerosis, sepsis and obesity. Therefore, following a correct dietary model may be
      beneficial in order to limit postprandial excursion and to modulate hormonal responses
      involved in satiety.

      The physiological postprandial response depends on several factors, both intrinsic, such as
      natural characteristic of food, and extrinsic, such as the way in which food is processed.
      Thus, the present study aims at evaluating if the reformulation of some commercial
      confectionery products can lead to an improvement of the nutritional profile, through a
      decrease of postprandial metabolic and hormonal, oxidative stress, inflammation and
      endotoxaemia responses in comparison with commercial confectionery products (snacks).
    

Intervention name(s): control snack; control cream; cream version 1; cream version 2; cream version 3; control chocolate bar; chocolate bar version 1
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): dry fruit snack (200 kcal) + 250 ml water; commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water; commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water; commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water; commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water; commercial chocolate bar (200 kcal)+ 250 ml water; commercial chocolate bar (200 kcal), version 1+ 250 ml water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a cross-over, randomized intervention trial. Each subject consumed in a randomly order seven foods test with a one-week wash out between different treatments. The portion size of each foods test was calculated in order to provide the same calories.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention