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Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products (FP1)

Primary Purpose

Glucose, High Blood, Inflammatory Response, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
control snack
control cream
cream version 1
cream version 2
cream version 3
control chocolate bar
chocolate bar version 1
Sponsored by
University of Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glucose, High Blood

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Parma

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

control snack

control cream

cream version 1

cream version 2

cream version 3

control chocolate bar

chocolate bar version 1

Arm Description

control snack

control spreadable cream

control spreadable cream, version 1

control spreadable cream, version 2

control spreadable cream, version 3

control chocolate bar

control chocolate bar version 1

Outcomes

Primary Outcome Measures

IAUC postprandial blood glucose
Incremental area under the curve of blood glucose postprandial response (IAUC)

Secondary Outcome Measures

Postprandial response for blood glucose
incremental 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)
Incremental 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)
incremental blood insulin concentration at each timepoint of the curve
IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
Incremental area under the curve for blood TAG and NEFA postprandial response (IAUC)
Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
incremental blood TAG and NEFA concentration at each timepoint of the curve
IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
Incremental 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)
incremental 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))
Incremental area under the curve for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
incremental 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))
Incremental area under the curve for LPS
Postprandial response for blood LPS
incremental blood LPS concentration at each timepoint of the curve

Full Information

First Posted
May 31, 2019
Last Updated
April 26, 2021
Sponsor
University of Parma
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1. Study Identification

Unique Protocol Identification Number
NCT03972878
Brief Title
Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products
Acronym
FP1
Official Title
Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Parma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose, High Blood, Inflammatory Response, Oxidative Stress, Endotoxemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control snack
Arm Type
Active Comparator
Arm Description
control snack
Arm Title
control cream
Arm Type
Experimental
Arm Description
control spreadable cream
Arm Title
cream version 1
Arm Type
Experimental
Arm Description
control spreadable cream, version 1
Arm Title
cream version 2
Arm Type
Experimental
Arm Description
control spreadable cream, version 2
Arm Title
cream version 3
Arm Type
Experimental
Arm Description
control spreadable cream, version 3
Arm Title
control chocolate bar
Arm Type
Experimental
Arm Description
control chocolate bar
Arm Title
chocolate bar version 1
Arm Type
Experimental
Arm Description
control chocolate bar version 1
Intervention Type
Other
Intervention Name(s)
control snack
Intervention Description
dry fruit snack (200 kcal) + 250 ml water
Intervention Type
Other
Intervention Name(s)
control cream
Intervention Description
commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water
Intervention Type
Other
Intervention Name(s)
cream version 1
Intervention Description
commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water
Intervention Type
Other
Intervention Name(s)
cream version 2
Intervention Description
commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water
Intervention Type
Other
Intervention Name(s)
cream version 3
Intervention Description
commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water
Intervention Type
Other
Intervention Name(s)
control chocolate bar
Intervention Description
commercial chocolate bar (200 kcal)+ 250 ml water
Intervention Type
Other
Intervention Name(s)
chocolate bar version 1
Intervention Description
commercial chocolate bar (200 kcal), version 1+ 250 ml water
Primary Outcome Measure Information:
Title
IAUC postprandial blood glucose
Description
Incremental area under the curve of blood glucose postprandial response (IAUC)
Time Frame
0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Secondary Outcome Measure Information:
Title
Postprandial response for blood glucose
Description
incremental blood glucose concentration at each timepoint of the curve
Time Frame
0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Title
IAUC postprandial blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
Description
Incremental area under the curve for blood insulin postprandial response (IAUC)
Time Frame
0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Title
Postprandial response for blood hormones (insulin, c-peptide, ghrelin, Glucagon-like peptide 1 (GLP-1), Gastric inhibitory peptide (GIP), peptide YY (PYY), leptin)
Description
incremental blood insulin concentration at each timepoint of the curve
Time Frame
0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Title
IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
Description
Incremental area under the curve for blood TAG and NEFA postprandial response (IAUC)
Time Frame
0 (fasting), 30, 60, 90, 120, 180, 240 minutes
Title
Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)
Description
incremental blood TAG and NEFA concentration at each timepoint of the curve
Time Frame
0 (fasting), 30, 60, 90, 120, 180, 240 minutes
Title
IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
Description
Incremental area under the curve for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) postprandial response (IAUC)
Time Frame
0 (fasting), 60, 90, 120, 180, 240 minutes
Title
Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
Description
incremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) concentration at each timepoint of the curve
Time Frame
0 (fasting), 60, 90, 120, 180, 240 minutes
Title
IAUC postprandial blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Description
Incremental area under the curve for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Time Frame
0 (fasting), 60, 90, 120, 180, 240 minutes
Title
Postprandial response for blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP))
Description
incremental blood oxidative stress related markers glutathione (GSH) and antioxidant capacity (Ferric ion reducing antioxidant power (FRAP)) concentration at each timepoint of the curve
Time Frame
0 (fasting), 60, 90, 120, 180, 240 minutes
Title
IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))
Description
Incremental area under the curve for LPS
Time Frame
0 (fasting), 60, 90, 120, 180, 240 minutes
Title
Postprandial response for blood LPS
Description
incremental blood LPS concentration at each timepoint of the curve
Time Frame
0 (fasting), 60, 90, 120, 180, 240 minutes
Other Pre-specified Outcome Measures:
Title
Postprandial satiety using a 100mm visual analog scale
Description
Differences 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.
Time Frame
0 (fasting), 15, 30, 60, 120, 240 minutes
Title
Palatability
Description
Palatability using a 100mm visual analog scale (centimeter). Range 0-10 centimeter. Higher is the value of palatability better is the product.
Time Frame
12 minutes (after consumption)
Title
Postprandial gastrointestinal symptoms using a 100mm visual analog scale
Description
gastrointestinal symptoms using a 100mm visual analog scale (centimeter). range 0-10 centimeter. Lower are the values of gastrointestinal symptoms better is the product.
Time Frame
0 (fasting), 15, 30, 60, 120, 240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Parma
City
Parma
ZIP/Postal Code
43125
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
28298267
Citation
Emerson SR, Kurti SP, Harms CA, Haub MD, Melgarejo T, Logan C, Rosenkranz SK. Magnitude and Timing of the Postprandial Inflammatory Response to a High-Fat Meal in Healthy Adults: A Systematic Review. Adv Nutr. 2017 Mar 15;8(2):213-225. doi: 10.3945/an.116.014431. Print 2017 Mar.
Results Reference
background
PubMed Identifier
17991637
Citation
Erridge C, Attina T, Spickett CM, Webb DJ. A high-fat meal induces low-grade endotoxemia: evidence of a novel mechanism of postprandial inflammation. Am J Clin Nutr. 2007 Nov;86(5):1286-92. doi: 10.1093/ajcn/86.5.1286.
Results Reference
background
PubMed Identifier
23847095
Citation
Herieka M, Erridge C. High-fat meal induced postprandial inflammation. Mol Nutr Food Res. 2014 Jan;58(1):136-46. doi: 10.1002/mnfr.201300104. Epub 2013 Jul 12.
Results Reference
background
PubMed Identifier
17719342
Citation
O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26.
Results Reference
background
PubMed Identifier
8923057
Citation
Treib J, Haass A, Kiessig ST, Woessner R, Grauer MT, Schimrigk K. Tick-borne encephalitis diagnosis in patients with inflammatory changes in the cerebrospinal fluid in a region with very low prevalence. Infection. 1996 Sep-Oct;24(5):400-2. doi: 10.1007/BF01716095.
Results Reference
background

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Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

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