Clinical trial NCT03972878: Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products
Official title: Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, High Blood
Inflammatory Response
Oxidative Stress
Endotoxemia
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: IAUC postprandial blood glucose
timeFrame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Secondary outcomes:
measure: Postprandial response for blood glucose
timeFrame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
measure: IAUC postprandial blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
timeFrame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
measure: Postprandial response for blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
timeFrame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
measure: IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
timeFrame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
measure: Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
timeFrame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
measure: IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
timeFrame: 0 (fasting), 60, 90, 120, 180, 240 minutes
measure: Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
timeFrame: 0 (fasting), 60, 90, 120, 180, 240 minutes
measure: IAUC postprandial blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
timeFrame: 0 (fasting), 60, 90, 120, 180, 240 minutes
measure: Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
timeFrame: 0 (fasting), 60, 90, 120, 180, 240 minutes
measure: IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))
timeFrame: 0 (fasting), 60, 90, 120, 180, 240 minutes
measure: Postprandial response for blood LPS
timeFrame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Other outcomes:
measure: Postprandial satiety using a 100mm visual analog scale
timeFrame: 0 (fasting), 15, 30, 60, 120, 240 minutes
measure: Palatability
timeFrame: 12 minutes (after consumption)
measure: Postprandial gastrointestinal symptoms using a 100mm visual analog scale
timeFrame: 0 (fasting), 15, 30, 60, 120, 240 minutes
Locations:
city: Parma
country: Italy
facility: University of Parma
Study officials:
References:
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