Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629742
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2020-10-29
Brief Title:
Low Sodium Neapolitan Pizza Prepared With Seawater Nutritional Properties Sensory Characteristics Metabolic Effects
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
A Lower Sodium Neapolitan Pizza Prepared With Seawater in Place of Salt Nutritional Properties Sensory Characteristics and Metabolic Effects
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Seawater is rich in minerals which may help confer good palatability to foods favouring the use of smaller amounts of salt a recognized measure of cardiovascular prevention The aim of this study is to investigate the nutritional properties sensory characteristics and metabolic effects of a typical Neapolitan pizza prepared with seawater SWP in place of common salt in comparison with Standard traditional Pizza StP Methods The nutritional characteristics and the chemical profile of the SWP and StP were assessed by chemical analyses and the use of Food Composition Tables Twelve healthy volunteers will be recruited for a Randomized Controlled Trial with the consumption of one StP and one SWP using a balanced crossover design The satiating power and palatability of the two pizzas will be tested by the administration of Visual Analogue Scales Serum glucose insulin and sodium will be measured every 30 minutes and 3-hour urines will be collected after each meal
Detailed Description:
The aim of the present study is testing the nutritional properties the sensory characteristics and the metabolic effects of a novel recipe of Neapolitan pizza featuring the substitution of common salt with commercial seawater in such proportion as to reduce the total amount of sodium chloride in the otherwise traditional dough by approximately 50
The dough for both StP and SWP will be prepared from 170 g of organic flour Agguggiaro and Figna 5 stagioni 80 type 0020 type 1 Curatolo Padova Italy with the addition of 110 mL of tap water or commercial seawater respectively To the StP 005 g of brewers yeast and 5 g of unrefined salt Sale Vero Oro di Sicilia Srl Nubia di Paceno Trapani Italy will be added while only 002 g of yeast and no salt were added to the SWP Because salt is known to reduce the fermentation rate based on the calculation that the amount of sodium chloride in SWP would be approximately one half of the StP content it was decided to use approximately half the amount of yeast while maintaining constant the fermentation time which was 15 h for both doughs Commercial seawater is supplied by Steralmar Srl Bisceglie BT Italia
The trial is conceived as a double blind balanced randomised crossover trial where each subject acted as hisher own control by consuming the two different pizzas at one week elapsed time from one another according to a balanced randomised sequence The trial was approved by the Ethical Committee of the University of Naples Federico II n 40320
The participants will sign an informed consent to participate and receive detailed written instructions by a trained researcher about the study protocol avoid any intense physical activity and complete the evening meal by 9 pm on the day before the test have a standard breakfast explained in detail before 830 on the morning of the test drink at least 300 mL of water between breakfast and the meal test to guarantee normal hydration not eating between breakfast and the meal test to guarantee a standard hunger level
Weight height and blood pressure BP will be measured just before the test systolic and diastolic blood pressure and heart rate will be measured 3 times and the participants will be requested to void just before being weighted and the urines produced thereafter during the 3 h of the test will be collected
The meals will be consumed in groups of 4 volunteers at a time under standard conditions in the metabolic kitchen at Federico II University Hospital
The volunteers will be requested to drink 300 mL of water during the meal which will have a maximum duration of 20 min An additional volume of 300 mL has to be drunk in the 3 h after the meal In both meals at intervals of 30 min for a total of 3 h a battery of Visual Analogue Scales VAS will be administered to assess possible differences in the satiating power of the two pizzas and their sensory characteristics as described in the dedicated session
Blood samples will be drawn from an indwelling antecubital venous cannula for the measurement of glucose insulin and sodium concentration in the fasting state and every 30 min thereafter for 3 h after eating was begun and the Area Under the Curve will be calculated
The volume of the 3 h urine collection will be measured and the sodium and creatinine concentrations measured by ISE and by an enzymatic colorimetric method
The dough for both StP and SWP will be prepared from 170 g of organic flour Agguggiaro and Figna 5 stagioni 80 type 0020 type 1 Curatolo Padova Italy with the addition of 110 mL of tap water or commercial seawater respectively To the StP 005 g of brewers yeast and 5 g of unrefined salt Sale Vero Oro di Sicilia Srl Nubia di Paceno Trapani Italy will be added while only 002 g of yeast and no salt were added to the SWP Because salt is known to reduce the fermentation rate based on the calculation that the amount of sodium chloride in SWP would be approximately one half of the StP content it was decided to use approximately half the amount of yeast while maintaining constant the fermentation time which was 15 h for both doughs Commercial seawater is supplied by Steralmar Srl Bisceglie BT Italia
The trial is conceived as a double blind balanced randomised crossover trial where each subject acted as hisher own control by consuming the two different pizzas at one week elapsed time from one another according to a balanced randomised sequence The trial was approved by the Ethical Committee of the University of Naples Federico II n 40320
The participants will sign an informed consent to participate and receive detailed written instructions by a trained researcher about the study protocol avoid any intense physical activity and complete the evening meal by 9 pm on the day before the test have a standard breakfast explained in detail before 830 on the morning of the test drink at least 300 mL of water between breakfast and the meal test to guarantee normal hydration not eating between breakfast and the meal test to guarantee a standard hunger level
Weight height and blood pressure BP will be measured just before the test systolic and diastolic blood pressure and heart rate will be measured 3 times and the participants will be requested to void just before being weighted and the urines produced thereafter during the 3 h of the test will be collected
The meals will be consumed in groups of 4 volunteers at a time under standard conditions in the metabolic kitchen at Federico II University Hospital
The volunteers will be requested to drink 300 mL of water during the meal which will have a maximum duration of 20 min An additional volume of 300 mL has to be drunk in the 3 h after the meal In both meals at intervals of 30 min for a total of 3 h a battery of Visual Analogue Scales VAS will be administered to assess possible differences in the satiating power of the two pizzas and their sensory characteristics as described in the dedicated session
Blood samples will be drawn from an indwelling antecubital venous cannula for the measurement of glucose insulin and sodium concentration in the fasting state and every 30 min thereafter for 3 h after eating was begun and the Area Under the Curve will be calculated
The volume of the 3 h urine collection will be measured and the sodium and creatinine concentrations measured by ISE and by an enzymatic colorimetric method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None