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临床试验/NCT04629742
NCT04629742已完成不适用

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

Federico II University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Evaluation of the satiating power of the pizza

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Nobody (unless the principal investigator) knows the types of pizza and their coding system

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 years,
  • •healthy volunteers

排除标准

  • •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.

研究组 & 干预措施

Seawater Pizza

Experimental

Administration of a seawater pizza

干预措施: Seawater Pizza (Other)

Standard Pizza

Active Comparator

Administration of a Standard pizza

干预措施: Standard pizza (Other)

结局指标

主要结局

Evaluation of the satiating power of the pizza

时间窗: 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

Evaluation of sensory characteristics of the pizza

时间窗: 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

次要结局

  • 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 the sodium excretion(3 hours)
  • Evaluation of sodium metabolism(3 hours)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pasquale Strazzullo

Principal investigator

Federico II University

研究点 (1)

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