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Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03972878
Acronym
FP1
Enrollment
13
Registered
2019-06-04
Start date
2019-03-22
Completion date
2020-12-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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).

Interventions

dry fruit snack (200 kcal) + 250 ml water

commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water

OTHERcream version 1

commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water

OTHERcream version 2

commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water

OTHERcream version 3

commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water

OTHERcontrol chocolate bar

commercial chocolate bar (200 kcal)+ 250 ml water

OTHERchocolate bar version 1

commercial chocolate bar (200 kcal), version 1+ 250 ml water

Sponsors

University of Parma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IAUC postprandial blood glucose0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutesIncremental area under the curve of blood glucose postprandial response (IAUC)

Secondary

MeasureTime frameDescription
Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)0 (fasting), 30, 60, 90, 120, 180, 240 minutesincremental blood TAG and NEFA concentration at each timepoint of the curve
Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))0 (fasting), 60, 90, 120, 180, 240 minutesincremental blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) concentration at each timepoint of the curve
IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))0 (fasting), 60, 90, 120, 180, 240 minutesIncremental area under the curve for LPS
Postprandial response for blood LPS0 (fasting), 60, 90, 120, 180, 240 minutesincremental blood LPS concentration at each timepoint of the curve
Postprandial response for blood glucose0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutesincremental blood glucose concentration at each timepoint of the curve
IAUC postprandial blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutesIncremental area under the curve for blood insulin postprandial response (IAUC)
Postprandial response for blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutesincremental blood insulin concentration at each timepoint of the curve
IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)0 (fasting), 30, 60, 90, 120, 180, 240 minutesIncremental area under the curve for blood TAG and NEFA postprandial response (IAUC)
IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)0 (fasting), 60, 90, 120, 180, 240 minutesIncremental area under the curve for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) postprandial response (IAUC)
Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)0 (fasting), 60, 90, 120, 180, 240 minutesincremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) concentration at each timepoint of the curve
IAUC postprandial blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))0 (fasting), 60, 90, 120, 180, 240 minutesIncremental area under the curve for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))

Other

MeasureTime frameDescription
Postprandial gastrointestinal symptoms using a 100mm visual analog scale0 (fasting), 15, 30, 60, 120, 240 minutesgastrointestinal symptoms using a 100mm visual analog scale (centimeter). range 0-10 centimeter. Lower are the values of gastrointestinal symptoms better is the product.
Postprandial satiety using a 100mm visual analog scale0 (fasting), 15, 30, 60, 120, 240 minutesDifferences 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.
Palatability12 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026