An interventional study of control snack and control cream in Glucose, High Blood, Inflammatory Response and Oxidative Stress, sponsored by University of Parma. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by University of Parma · Not applicable, Interventional, and Prevention
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:
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.
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).
81 studies on the registry are indexed under Endotoxemia; 7 are open to participants now.
This study's enrollment of 13 is below the median of 31 across 70 interventional studies indexed under Endotoxemia.
Browse Endotoxemia studies →University of Parma is the lead sponsor of 77 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
control snack
Other: control snack
control spreadable cream
Other: control cream
control spreadable cream, version 1
Other: cream version 1
control spreadable cream, version 2
Other: cream version 2
control spreadable cream, version 3
Other: cream version 3
control chocolate bar
Other: control chocolate bar
control chocolate bar version 1
Other: chocolate bar version 1
dry fruit snack (200 kcal) + 250 ml water
commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water
commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water
commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water
commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water
commercial chocolate bar (200 kcal)+ 250 ml water
commercial chocolate bar (200 kcal), version 1+ 250 ml water
IAUC postprandial blood glucose
Incremental area under the curve of blood glucose postprandial response (IAUC)
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
Postprandial response for blood glucose
incremental blood glucose concentration at each timepoint of the curve
Time frame: 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)
Incremental area under the curve for blood insulin postprandial response (IAUC)
Time frame: 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)
incremental blood insulin concentration at each timepoint of the curve
Time frame: 0 (fasting), 15, 30, 45, 60, 90, 120, 180, 240 minutes
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)
Time frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
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
Time frame: 0 (fasting), 30, 60, 90, 120, 180, 240 minutes
IAUC postprandial blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
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)
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1)
incremental blood inflammatory markers (IL-6, IL-8, IL-10, IL-17, TNF-α, hsCRP, MCP-1) concentration at each timepoint of the curve
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
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))
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
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
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
IAUC postprandial blood endotoxemia (Lipopolysaccharides (LPS))
Incremental area under the curve for LPS
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
Postprandial response for blood LPS
incremental blood LPS concentration at each timepoint of the curve
Time frame: 0 (fasting), 60, 90, 120, 180, 240 minutes
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.
Time frame: 0 (fasting), 15, 30, 60, 120, 240 minutes
Palatability
Palatability using a 100mm visual analog scale (centimeter). Range 0-10 centimeter. Higher is the value of palatability better is the product.
Time frame: 12 minutes (after consumption)
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.
Time frame: 0 (fasting), 15, 30, 60, 120, 240 minutes
Ran from Mar 2019 to primary completion in Jul 2019, 4 months.
Of 29 non-industry interventional studies with no phase under Endotoxemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 4 months is below that.
Counting every sponsor, half of 31 studies reached it within 17 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Parma