Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products

Oxidative Stress Clinical Trial

— FP1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972878
• Other study ID #: FP-1.0
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotoxemia
• Glucose, High Blood
• Hyperglycemia
• Inflammatory Response
• Oxidative Stress

Intervention

Other:
• control snack
dry fruit snack (200 kcal) + 250 ml water
• control cream
commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water
• cream version 1
commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water
• cream version 2
commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water
• cream version 3
commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water
• control chocolate bar
commercial chocolate bar (200 kcal)+ 250 ml water
• chocolate bar version 1
commercial chocolate bar (200 kcal), version 1+ 250 ml water

Locations

Country	Name	City	State
Italy	University of Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 Jun 26. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-a, hsCRP, MCP-1)	Incremental area under the curve for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-a, hsCRP, MCP-1) postprandial response (IAUC)	0 (fasting), 60, 90, 120, 180, 240 minutes
Secondary	Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-a, hsCRP, MCP-1)	incremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-a, hsCRP, MCP-1) concentration at each timepoint of the curve	0 (fasting), 60, 90, 120, 180, 240 minutes
Secondary	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
Secondary	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
Secondary	IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))	Incremental area under the curve for LPS	0 (fasting), 60, 90, 120, 180, 240 minutes
Secondary	Postprandial response for blood LPS	incremental blood LPS concentration at each timepoint of the curve	0 (fasting), 60, 90, 120, 180, 240 minutes