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Low Sodium Neapolitan Pizza Prepared With Seawater: Nutritional Properties, Sensory Characteristics, Metabolic Effects

Primary Purpose

Satiety Response, Carbohydrate Metabolism, Sodium Retention

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Seawater Pizza
Standard pizza
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Satiety Response focused on measuring salt reduction, seawater, pizza, hedonic food, water and sodium handling

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years,
  • healthy volunteers

Exclusion Criteria:

  • smoking,
  • hypertension,
  • diabetes,
  • hyperlipidemia,
  • eating disorders,
  • use of medications affecting satiety and hunger sensations,
  • past gastrointestinal surgery potentially affecting digestion and absorption processes,
  • presence of chronic diseases
  • strenuous physical activity.

Sites / Locations

  • Federico II University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Seawater Pizza

Standard Pizza

Arm Description

Administration of a seawater pizza

Administration of a Standard pizza

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 29, 2020
Last Updated
November 11, 2020
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT04629742
Brief Title
Low Sodium Neapolitan Pizza Prepared With Seawater: Nutritional Properties, Sensory Characteristics, Metabolic Effects
Official Title
A Lower Sodium Neapolitan Pizza Prepared With Seawater in Place of Salt: Nutritional Properties, Sensory Characteristics and Metabolic Effects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Satiety Response, Carbohydrate Metabolism, Sodium Retention
Keywords
salt reduction, seawater, pizza, hedonic food, water and sodium handling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Twelve healthy volunteers were recruited for a Randomized Controlled Trial, with the consumption of one Standard Pizza and one seawater pizza using a balanced crossover design, with 1 week wash out
Masking
ParticipantCare ProviderInvestigator
Masking Description
Nobody (unless the principal investigator) knows the types of pizza and their coding system
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seawater Pizza
Arm Type
Experimental
Arm Description
Administration of a seawater pizza
Arm Title
Standard Pizza
Arm Type
Active Comparator
Arm Description
Administration of a Standard pizza
Intervention Type
Other
Intervention Name(s)
Seawater Pizza
Intervention Description
A seawater pizza administered to 12 healthy subjects
Intervention Type
Other
Intervention Name(s)
Standard pizza
Intervention Description
A standard pizza administered to 12 healthy subjects
Primary Outcome Measure Information:
Title
Evaluation of sensory characteristics of the pizza
Description
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
Title
Evaluation of the satiating power of the pizza
Description
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
Secondary Outcome Measure Information:
Title
Evaluation of the metabolic response of the study participants (glucose)
Description
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
Title
Evaluation of the metabolic response of the study participants (insulin)
Description
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
Title
Evaluation of sodium metabolism
Description
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
Title
Evaluation of the sodium excretion
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years, healthy volunteers Exclusion Criteria: smoking, hypertension, diabetes, hyperlipidemia, eating disorders, use of medications affecting satiety and hunger sensations, past gastrointestinal surgery potentially affecting digestion and absorption processes, presence of chronic diseases strenuous physical activity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale Strazzullo, MD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federico II University Hospital
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

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Low Sodium Neapolitan Pizza Prepared With Seawater: Nutritional Properties, Sensory Characteristics, Metabolic Effects

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