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

NCT04629742 | Completed

• 1 other identifier: 403.20
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Satiety Response; Carbohydrate Metabolism; Sodium Retention

Keywords

salt reduction; seawater; pizza; hedonic food; water and sodium handling

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 hours

Secondary Outcomes (4)

• Evaluation of the metabolic response of the study participants (glucose)

  3 hours

• Evaluation of the metabolic response of the study participants (insulin)

  3 hours

• Evaluation of sodium metabolism

  3 hours

• Evaluation of the sodium excretion

  3 hours

Study Arms (2)

Seawater Pizza

EXPERIMENTAL

Administration of a seawater pizza

Other: Seawater Pizza

Standard Pizza

ACTIVE COMPARATOR

Administration of a Standard pizza

Other: Standard pizza

Interventions

Seawater Pizza OTHER

A seawater pizza administered to 12 healthy subjects

Seawater Pizza

Standard pizza OTHER

A standard pizza administered to 12 healthy subjects

Standard Pizza

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years,
• healthy volunteers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Hypernatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pasquale Strazzullo, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Nobody (unless the principal investigator) knows the types of pizza and their coding system
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 16, 2020
• Study Start: March 10, 2020
• Primary Completion: June 15, 2020
• Study Completion: July 20, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

IT (1)