CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
control snack +6 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03972878
NCT03972878N/ACompleted

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

University of Parma·interventional·Posted Jun 4, 2019·Updated Apr 27, 2021

In Brief

A clinical study evaluating control snack, control cream, and 5 other interventions for Glucose, High Blood and 3 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 4, 2019
Enrollment StartMar 22, 2019
Primary CompletionJul 31, 2019
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.1 years ago

Interventions

control snackother

dry fruit snack (200 kcal) + 250 ml water

control creamother

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

cream version 1other

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

cream version 2other

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

cream version 3other

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

control chocolate barother

commercial chocolate bar (200 kcal)+ 250 ml water

chocolate bar version 1other

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