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

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

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 Overview

• Status: Completed
• Conditions: Inflammatory Response; Endotoxemia; Oxidative Stress; Glucose, High Blood
• Intervention / Treatment: Other: control snack; Other: control cream; Other: cream version 1; Other: cream version 2; Other: cream version 3; Other: control chocolate bar; Other: chocolate bar version 1

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).

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43125
    • University of Parma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control snack	Other: control snack; dry fruit snack (200 kcal) + 250 ml water
EXPERIMENTAL: control cream; control spreadable cream	Other: control cream; commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water
EXPERIMENTAL: cream version 1; control spreadable cream, version 1	Other: cream version 1; commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water
EXPERIMENTAL: cream version 2; control spreadable cream, version 2	Other: cream version 2; commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water
EXPERIMENTAL: cream version 3; control spreadable cream, version 3	Other: cream version 3; commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water
EXPERIMENTAL: control chocolate bar	Other: control chocolate bar; commercial chocolate bar (200 kcal)+ 250 ml water
EXPERIMENTAL: chocolate bar version 1; control chocolate bar version 1	Other: chocolate bar version 1; commercial chocolate bar (200 kcal), version 1+ 250 ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IAUC postprandial blood glucose	Incremental area under the curve of blood glucose postprandial response (IAUC)	0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial response for blood glucose	incremental blood glucose concentration at each timepoint of the curve	0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
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)	0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
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	0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
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)	0 (fasting), 30, 60, 90, 120, 180, 240 minutes
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	0 (fasting), 30, 60, 90, 120, 180, 240 minutes
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)	0 (fasting), 60, 90, 120, 180, 240 minutes
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	0 (fasting), 60, 90, 120, 180, 240 minutes
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))	0 (fasting), 60, 90, 120, 180, 240 minutes
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	0 (fasting), 60, 90, 120, 180, 240 minutes
IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))	Incremental area under the curve for LPS	0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood LPS	incremental blood LPS concentration at each timepoint of the curve	0 (fasting), 60, 90, 120, 180, 240 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial satiety using a 100mm visual analog scale	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.	0 (fasting), 15, 30, 60, 120, 240 minutes
Palatability	Palatability using a 100mm visual analog scale (centimeter). Range 0-10 centimeter. Higher is the value of palatability better is the product.	12 minutes (after consumption)
Postprandial gastrointestinal symptoms using a 100mm visual analog scale	gastrointestinal symptoms using a 100mm visual analog scale (centimeter). range 0-10 centimeter. Lower are the values of gastrointestinal symptoms better is the product.	0 (fasting), 15, 30, 60, 120, 240 minutes

Collaborators and Investigators

• Sponsor: University of Parma

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2019
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Bacteremia; Toxemia; Endotoxemia
• Other Study ID Numbers: FP-1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No