Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products — FP1  

Oxidative Stress Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Endotoxemia
• Glucose, High Blood
• Hyperglycemia
• Inflammatory Response
• Oxidative Stress

• NCT number: NCT03972878
• Study type: Interventional
• Source: University of Parma
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Completion date: December 31, 2020