An interventional study of Seawater Pizza and Standard pizza in Satiety Response, Carbohydrate Metabolism and Sodium Retention, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by Federico II University · Not applicable, Interventional, and Prevention
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.
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 00/20% type 1, Curatolo, Padova, Italy) with the addition of 110 mL of tap water or commercial seawater respectively. To the StP 0.05 g of brewer's yeast and 5 g of unrefined salt (Sale Vero, Oro di Sicilia Srl, Nubia di Paceno, Trapani, Italy) will be added, while only 0.02 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 his/her 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. 403.20).
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 8.30 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.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's enrollment of 12 is below the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Administration of a seawater pizza
Other: Seawater Pizza
Administration of a Standard pizza
Other: Standard pizza
A seawater pizza administered to 12 healthy subjects
A standard pizza administered to 12 healthy subjects
Evaluation of sensory characteristics of the pizza
Administration of a Visual Analogue Scale (VAS) just after the meal for testing the following four sensory characteristics: chewness, flavour, saltiness, general pleasantness
Time frame: 20 minutes
Evaluation of the satiating power of the pizza
Administration of a Visual Analogue Scale (VAS) for a 3 hours period for testing the followings: hunger, satiety, desire to eat more pizza, prospective to eat more
Time frame: 3 hours
Evaluation of the metabolic response of the study participants (glucose)
Evaluation of changes in glucose parameters. Blood samples will be drawn from an indwelling antecubital venous cannula for the measurement of glucose concentration in the fasting state and every 30 min thereafter for 3 h after eating is begun. Serum glucose level will be measured by an enzymatic colorimetric method (Pentra 400, Horiba ABX, Rome, Italy), and tha area under the curve will be calculated.
Time frame: 3 hours
Evaluation of the metabolic response of the study participants (insulin)
Evaluation of changes in insulin parameters. Blood samples will be drawn from an indwelling antecubital venous cannula for the measurement of insulin concentration in the fasting state and every 30 min thereafter for 3 h after eating is begun, Serum insulin concentration will be measured by ELISA (DIA source, Dusseldorf, Germany) and the area under the curve will be calculated.
Time frame: 3 hours
Evaluation of sodium metabolism
Blood samples will be drawn from an indwelling antecubital venous cannula for the measurement of sodium concentration in the fasting state and every 30 min thereafter for 3 h after eating was begun. Plasma sodium concentration will be measured by an ion-selective electrode (ISE) method (Pentra 400, Horiba ABX, Rome, Italy) and the Area Under the Curve will be calculated.
Time frame: 3 hours
Evaluation of the sodium excretion
The volume of the 3 h urine collection will be measured, and the sodium and creatinine concentrations will be measured by ISE and by an enzymatic colorimetric method. Urinary sodium excretion will be calculated in grams.
Time frame: 3 hours
Ran from Mar 2020 to primary completion in Jun 2020, 3 months.
Of 12 interventional studies with no phase under Hypernatremia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 3 months is below that.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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