Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

Study Overview
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Brief Summary
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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
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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).

Official Title
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Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products

Conditions
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Glucose, High Blood, Inflammatory Response, Oxidative Stress, Endotoxemia

Intervention / Treatment
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* Other: control snack
* Other: control cream
* Other: cream version 1
* Other: cream version 2
* Other: cream version 3
* Other: control chocolate bar
* Other: chocolate bar version 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy male and female adult subjects Exclusion Criteria: BMI > 30 kg/m2 Metabolic disorders (diabetes, hypertension, dyslipidemia, glucidic intolerance) Chronic drug therapies for any pathologies (including psychiatric diseases) Dietary supplements affecting metabolism of glucose and lipid Celiac disease Pregnancy or lactation Lactose intolerance Food allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control snack<br>control snack | Other: control snack<br>* dry fruit snack (200 kcal) + 250 ml water<br>|
| Experimental: control cream<br>control spreadable cream | Other: control cream<br>* commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water<br>|
| Experimental: cream version 1<br>control spreadable cream, version 1 | Other: cream version 1<br>* commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water<br>|
| Experimental: cream version 2<br>control spreadable cream, version 2 | Other: cream version 2<br>* commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water<br>|
| Experimental: cream version 3<br>control spreadable cream, version 3 | Other: cream version 3<br>* commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water<br>|
| Experimental: control chocolate bar<br>control chocolate bar | Other: control chocolate bar<br>* commercial chocolate bar (200 kcal)+ 250 ml water<br>|
| Experimental: chocolate bar version 1<br>control chocolate bar version 1 | Other: chocolate bar version 1<br>* commercial chocolate bar (200 kcal), version 1+ 250 ml water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IAUC postprandial blood glucose | Incremental area under the curve of blood glucose postprandial response (IAUC) | 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial response for blood glucose | incremental blood glucose concentration at each timepoint of the curve | 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes | 
| IAUC postprandial blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin) | Incremental area under the curve for blood insulin postprandial response (IAUC) | 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes | 
| Postprandial response for blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin) | incremental blood insulin concentration at each timepoint of the curve | 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes | 
| IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA) | Incremental area under the curve for blood TAG and NEFA postprandial response (IAUC) | 0 (fasting), 30, 60, 90, 120, 180, 240 minutes | 
| Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA) | incremental blood TAG and NEFA concentration at each timepoint of the curve | 0 (fasting), 30, 60, 90, 120, 180, 240 minutes | 
| IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) | Incremental area under the curve for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) postprandial response (IAUC) | 0 (fasting), 60, 90, 120, 180, 240 minutes | 
| Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) | incremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) concentration at each timepoint of the curve | 0 (fasting), 60, 90, 120, 180, 240 minutes | 
| IAUC postprandial blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) | Incremental area under the curve for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) | 0 (fasting), 60, 90, 120, 180, 240 minutes | 
| Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) | incremental blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) concentration at each timepoint of the curve | 0 (fasting), 60, 90, 120, 180, 240 minutes | 
| IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS)) | Incremental area under the curve for LPS | 0 (fasting), 60, 90, 120, 180, 240 minutes | 
| Postprandial response for blood LPS | incremental blood LPS concentration at each timepoint of the curve | 0 (fasting), 60, 90, 120, 180, 240 minutes |