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.
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
- Conditions the study is for
- Satiety Response, Carbohydrate Metabolism, Sodium Retention
- 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.
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.
- Conditions
- Satiety Response, Carbohydrate Metabolism, Sodium Retention
- 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 group | Role | What they receive |
|---|---|---|
| Seawater Pizza | Experimental | Administration of a seawater pizza Receives: Other: Seawater Pizza |
| Standard Pizza | Active comparator | Administration 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.
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
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)
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
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
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
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.
- First posted16 Nov 2020
- Study start10 Mar 2020
- Primary completion15 Jun 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satiety ResponseStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Strazzullo, Federico II University
- Investigators
- Pasquale Strazzullo, MD, Principal investigator, Federico II University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lower Sodium Neapolitan Pizza Prepared With Seawater in Place of Salt: Nutritional Properties, Sensory Characteristics and Metabolic Effects
- ClinicalTrials.gov ID
- NCT04629742
- Acronym / sponsor ID
- 403.20
- Conditions
- Satiety Response, Carbohydrate Metabolism, Sodium Retention
- Keywords
- salt reduction, seawater, pizza, hedonic food, water and sodium handling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Seawater Pizza | Experimental | Other: Seawater PizzaAdministration of a seawater pizza |
| Standard Pizza | Active comparator | Other: Standard pizzaAdministration of a Standard pizza |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years,
- healthy volunteers
Key exclusion criteria (9 listed)
- smoking,
- hypertension,
- diabetes,
- hyperlipidemia,
- eating disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seawater PizzaA seawater pizza administered to 12 healthy subjects | Other | Seawater Pizza |
| Standard pizzaA standard pizza administered to 12 healthy subjects | Other | Standard Pizza |
Primary outcome
Evaluation of sensory characteristics of the pizza
Time frame: 20 minutes
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
Time frame: 3 hours
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
4 secondary outcomes
Evaluation of the metabolic response of the study participants (glucose)
Time frame: 3 hours
Evaluation of the metabolic response of the study participants (insulin)
Time frame: 3 hours
Evaluation of sodium metabolism
Time frame: 3 hours
Evaluation of the sodium excretion
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
Related trials for Satiety Response
Active, not recruiting
Postprandial Glycemic and GLP-1 Responses to Modified Full-sugar Drinks
Postprandial Glucose, GLP-1 Concentration
Not yet recruiting
Glycaemic Response of Arabic Bread
Overweight, Obesity
Recruiting
Satiety Evaluation of Mature Okra Flour-incorporated Biscuit
Appetite Regulation, Healthy Young Adults
Recruiting
Effect of Lemon Juice and Apple Cider Vinegar on Postprandial Blood Glucose and Satiety in Healthy Individuals
Satiety, Postprandial Glycemia
Recruiting
Snacking Effects on the Brain Response to Foods and Satiety During Dieting
Overweight/Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Strazzullo, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
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.