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Satiety ResponseNCT04629742

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

A study testing Seawater Pizza and Standard pizza in people with Satiety Response and Carbohydrate Metabolism, run by Federico II University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
Seawater Pizza and Standard pizza
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteItaly
Study dates
10 Mar 2020to 20 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 years,
  • healthy volunteers

Who cannot join

  • smoking,
  • hypertension,
  • diabetes,
  • hyperlipidemia,
  • eating disorders,
  • use of medications affecting satiety and hunger sensations,
Show all 9Show fewer
  • past gastrointestinal surgery potentially affecting digestion and absorption processes,
  • presence of chronic diseases
  • strenuous physical activity.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Federico II University Hospital

    Naples, 80131

Other trials in Italy

About this study

Official title: A Lower Sodium Neapolitan Pizza Prepared With Seawater in Place of Salt: Nutritional Properties, Sensory Characteristics and Metabolic Effects

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.

Read the 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.

Being tested
Seawater Pizza, Standard pizza
Keywords
salt reduction, seawater, pizza, hedonic food, water and sodium handling
Medical subject headings
Hypernatremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seawater PizzaOther

    A seawater pizza administered to 12 healthy subjects

  • Standard pizzaOther

    A standard pizza administered to 12 healthy subjects

Study groups in NCT04629742
Study groupRoleWhat they receive
Seawater PizzaExperimentalAdministration of a seawater pizza
Receives: Other: Seawater Pizza
Standard PizzaActive comparatorAdministration of a Standard pizza
Receives: Other: Standard pizza

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 20 minutes

  2. 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

    Measured: 3 hours

Secondary outcomes (4)
  1. 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.

    Measured: 3 hours

  2. 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.

    Measured: 3 hours

  3. 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.

    Measured: 3 hours

  4. 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.

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start10 Mar 2020
  3. Primary completion15 Jun 2020
  4. Study completion20 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04629742
Sponsor's protocol ID
403.20
Status last verified
Nov 2020
First submitted
29 Oct 2020
Last updated
16 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Seawater Pizza and Standard pizza in people with Satiety Response and Carbohydrate Metabolism, run by Federico II University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of sensory characteristics of the pizza (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.

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