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

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ClinicalTrials.gov Identifier: NCT03972878
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Daniele Del Rio, University of Parma

Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE March 22, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
IAUC postprandial blood glucose [ Time Frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes ]
Incremental area under the curve of blood glucose postprandial response (IAUC)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Postprandial response for blood glucose [ Time Frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes ]
    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) [ Time Frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes ]
    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) [ Time Frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes ]
    incremental blood insulin concentration at each timepoint of the curve
  • IAUC postprandial blood lipids triglycerides (TAG) and non esterified fatty acid (NEFA) [ Time Frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes ]
    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) [ Time Frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes ]
    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) [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    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) [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    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)) [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    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)) [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    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)) [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    Incremental area under the curve for LPS
  • Postprandial response for blood LPS [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    incremental blood LPS concentration at each timepoint of the curve
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2019)
  • Postprandial satiety using a 100mm visual analog scale [ Time Frame: 0 (fasting), 15, 30, 60, 120, 240 minutes ]
    Differences in subject-rated satiety using a 100mm visual analog scale
  • Palatability [ Time Frame: 12 minutes (after consumption) ]
    Palatability using a 100mm visual analog scale
  • Postprandial gastrointestinal symptoms using a 100mm visual analog scale [ Time Frame: 0 (fasting), 15, 30, 60, 120, 240 minutes ]
    gastrointestinal symptoms using a 100mm visual analog scale
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products
Official Title  ICMJE Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Postprandial Glycemia
  • Postprandial Inflammatory Response
  • Postprandial Oxidative Stress
  • Postprandial Endotoxemia
  • Food Quality
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: control snack
    control snack
    Intervention: Other: control snack
  • Experimental: control cream
    control spreadable cream
    Intervention: Other: control cream
  • Experimental: cream version 1
    control spreadable cream, version 1
    Intervention: Other: cream version 1
  • Experimental: cream version 2
    control spreadable cream, version 2
    Intervention: Other: cream version 2
  • Experimental: cream version 3
    control spreadable cream, version 3
    Intervention: Other: cream version 3
  • Experimental: control chocolate bar
    control chocolate bar
    Intervention: Other: control chocolate bar
  • Experimental: chocolate bar version 1
    control chocolate bar version 1
    Intervention: Other: chocolate bar version 1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daniele Del Rio, professor +39 0521 903830 daniele.delrio@unipr.it
Contact: Margherita Dall'Asta, PhD +39 0521 903841 margherita.dallasta@unipr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972878
Other Study ID Numbers  ICMJE FP-1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniele Del Rio, University of Parma
Study Sponsor  ICMJE University of Parma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Parma
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP