Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

NCT03972878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-04-27

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

control snack

dry fruit snack (200 kcal) + 250 ml water

OTHER

control cream

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

OTHER

cream version 1

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

OTHER

cream version 2

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

OTHER

cream version 3

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

OTHER

control chocolate bar

commercial chocolate bar (200 kcal)+ 250 ml water

OTHER

chocolate bar version 1

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

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2019-07-31
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972878 on ClinicalTrials.gov