Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

NCT03972878 | Completed

• 1 other identifier: FP-1.0
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Postprandial response for blood glucose

  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)

  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)

  0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes

• IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)

  0 (fasting), 30, 60, 90, 120, 180, 240 minutes

• Postprandial response for blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA)

  0 (fasting), 30, 60, 90, 120, 180, 240 minutes

Other Outcomes (3)

• Postprandial satiety using a 100mm visual analog scale

  0 (fasting), 15, 30, 60, 120, 240 minutes

• Palatability

  12 minutes (after consumption)

• Postprandial gastrointestinal symptoms using a 100mm visual analog scale

  0 (fasting), 15, 30, 60, 120, 240 minutes

Study Arms (7)

control snack

ACTIVE COMPARATOR

control snack

Other: control snack

control cream

EXPERIMENTAL

control spreadable cream

Other: control cream

cream version 1

EXPERIMENTAL

control spreadable cream, version 1

Other: cream version 1

cream version 2

EXPERIMENTAL

control spreadable cream, version 2

Other: cream version 2

cream version 3

EXPERIMENTAL

control spreadable cream, version 3

Other: cream version 3

control chocolate bar

EXPERIMENTAL

control chocolate bar

Other: control chocolate bar

chocolate bar version 1

EXPERIMENTAL

control chocolate bar version 1

Other: chocolate bar version 1

Interventions

control snack OTHER

dry fruit snack (200 kcal) + 250 ml water

control snack

control cream OTHER

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

control cream

cream version 1 OTHER

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

cream version 1

cream version 2 OTHER

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

cream version 2

cream version 3 OTHER

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

cream version 3

control chocolate bar OTHER

commercial chocolate bar (200 kcal)+ 250 ml water

control chocolate bar

chocolate bar version 1 OTHER

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

chocolate bar version 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy male and female adult subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

University of Parma

Parma, 43125, Italy

Location

Related Publications (5)

• 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.

  PMID: 28298267 BACKGROUND

• 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.

  PMID: 17991637 BACKGROUND

• 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.

  PMID: 23847095 BACKGROUND

• 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.

  PMID: 17719342 BACKGROUND

• 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.

  PMID: 8923057 BACKGROUND

MeSH Terms

Conditions

Endotoxemia

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition at Department of Veterinary Science, University of Parma

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: March 22, 2019
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

IT (1)