Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-22

Study Completion Date

2020-12-31

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.

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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).

Conditions

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Glucose, High Blood Inflammatory Response Oxidative Stress Endotoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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control snack

Group Type ACTIVE_COMPARATOR

control snack

Intervention Type OTHER

dry fruit snack (200 kcal) + 250 ml water

control cream

control spreadable cream

Group Type EXPERIMENTAL

control cream

Intervention Type OTHER

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

cream version 1

control spreadable cream, version 1

Group Type EXPERIMENTAL

cream version 1

Intervention Type OTHER

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

cream version 2

control spreadable cream, version 2

Group Type EXPERIMENTAL

cream version 2

Intervention Type OTHER

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

cream version 3

control spreadable cream, version 3

Group Type EXPERIMENTAL

cream version 3

Intervention Type OTHER

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

control chocolate bar

Group Type EXPERIMENTAL

control chocolate bar

Intervention Type OTHER

commercial chocolate bar (200 kcal)+ 250 ml water

chocolate bar version 1

control chocolate bar version 1

Group Type EXPERIMENTAL

chocolate bar version 1

Intervention Type OTHER

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

Interventions

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control snack

dry fruit snack (200 kcal) + 250 ml water

Intervention Type OTHER

control cream

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

Intervention Type OTHER

cream version 1

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

Intervention Type OTHER

cream version 2

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

Intervention Type OTHER

cream version 3

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

Intervention Type OTHER

control chocolate bar

commercial chocolate bar (200 kcal)+ 250 ml water

Intervention Type OTHER

chocolate bar version 1

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes