University of Parma
Parma, 43125, Italy
NCT Number: NCT03972878
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Parma, 43125, Italy
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Incremental area under the curve of blood glucose postprandial response (IAUC)
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
incremental blood glucose concentration at each timepoint of the curve
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Incremental area under the curve for blood insulin postprandial response (IAUC)
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
incremental blood insulin concentration at each timepoint of the curve
Time frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
Incremental area under the curve for blood TAG and NEFA postprandial response (IAUC)
Time frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
incremental blood TAG and NEFA concentration at each timepoint of the curve
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
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)
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
incremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) concentration at each timepoint of the curve
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Incremental area under the curve for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
incremental blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) concentration at each timepoint of the curve
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Incremental area under the curve for LPS
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
incremental blood LPS concentration at each timepoint of the curve
Time frame: 0 (fasting), 15, 30, 60, 120, 240 minutes
Differences in subject-rated satiety using a 100mm visual analog scale (centimeter) Range 0-10 centimeter. Higher are the values of satiety in each timepoints better is the product.
Time frame: 12 minutes (after consumption)
Palatability using a 100mm visual analog scale (centimeter). Range 0-10 centimeter. Higher is the value of palatability better is the product.
Time frame: 0 (fasting), 15, 30, 60, 120, 240 minutes
gastrointestinal symptoms using a 100mm visual analog scale (centimeter). range 0-10 centimeter. Lower are the values of gastrointestinal symptoms better is the product.
University of Parma
Other
Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
Acronym: FP1
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