Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04629742 |
| Other study ID # |
403.20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2020 |
| Est. completion date |
July 20, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 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.
