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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

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.


Condition or disease Intervention/treatment Phase
Postprandial Glycemia Postprandial Inflammatory Response Postprandial Oxidative Stress Postprandial Endotoxemia Food Quality 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 Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Foodprint 1.0: Metabolic, Hormonal, Inflammatory and Oxidative Post-prandial Responses After Consumption of Confectionary Products
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Active Comparator: control snack
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
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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)

  7. 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

  8. 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))

  9. 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

  10. IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS)) [ Time Frame: 0 (fasting), 60, 90, 120, 180, 240 minutes ]
    Incremental area under the curve for LPS

  11. 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


Other Outcome Measures:
  1. 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

  2. Palatability [ Time Frame: 12 minutes (after consumption) ]
    Palatability using a 100mm visual analog scale

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972878


Contacts
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Contact: Daniele Del Rio, professor +39 0521 903830 daniele.delrio@unipr.it
Contact: Margherita Dall'Asta, PhD +39 0521 903841 margherita.dallasta@unipr.it

Locations
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Italy
University of Parma Recruiting
Parma, Italy, 43125
Contact: Daniele Del Rio, Professor    +39 0521 903830    daniele.delrio@unipr.it   
Contact: Margherita Dall'Asta, PhD    +39 0521 903841    margherita.dallasta@unipr.it   
Sponsors and Collaborators
University of Parma

Publications:
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Responsible Party: Daniele Del Rio, Professor of Nutrition at Department of Veterinary Science, University of Parma, University of Parma
ClinicalTrials.gov Identifier: NCT03972878     History of Changes
Other Study ID Numbers: FP-1.0
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes