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Completed

NCT Number: NCT03972878

Foodprint 1.0: Physiological Acute 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Parma

Parma, 43125, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

control snack

Other

dry fruit snack (200 kcal) + 250 ml water

control cream

Other

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

cream version 1

Other

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

cream version 2

Other

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

cream version 3

Other

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

control chocolate bar

Other

commercial chocolate bar (200 kcal)+ 250 ml water

chocolate bar version 1

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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 (centimeter) Range 0-10 centimeter. Higher are the values of satiety in each timepoints better is the product.

  2. Palatability

    Time frame: 12 minutes (after consumption)

    Palatability using a 100mm visual analog scale (centimeter). Range 0-10 centimeter. Higher is the value of palatability better is the product.

  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 (centimeter). range 0-10 centimeter. Lower are the values of gastrointestinal symptoms better is the product.

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

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

Acronym: FP1

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 4, 2019
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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