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临床试验/NCT03841578
NCT03841578Unknown不适用

Effects of Dark Chocolate on Gastrointestinal Motility in Healthy Subjects

University of Bari1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Organoleptic assessment

研究概览

简要总结

Following food intake, the body activates several processes to degrade and digest it. Studies show that there is an adaptation of gastric emptying and gastrointestinal motility to a food component; therefore, considering the intestinal adaptation to chocolate, the effect on gastrointestinal motility in relation to the intake of chocolate will be investigated.

The organoleptic perceptions of dark chocolate will also be analyzed to evaluate the appreciation of the product ingested by the subject.

详细描述

Chocolate, the main product deriving from cocoa beans (Theobroma cacao, from the Greek "food of the gods") has its origin in Mexico, where Maya, Inca and Aztecs practiced its cultivation, has for centuries been appreciated for its pleasant taste and its beneficial health effects.

Chocolate is the most sought-after food worldwide, and currently its consumption has increased considerably with a wide availability of products on the market.

Dietary choices are strongly influenced by the taste and consistency of foods. Fat is largely responsible for the sensory properties of many foods and, therefore, contribute greatly to the pleasure of eating. Dark chocolate consists of ≈43% of lipids, mainly represented by cocoa butter. Cocoa butter is composed of an average of 33% of oleic acid, 25% of palmitic acid and 33% of stearic acid. Another component of chocolate is polyphenols, in particular flavonoids, substances with numerous beneficial effects for health, including antihypertensive, anti-inflammatory, antithrombotic, metabolic and prebiotic activity playing a role in the change of human intestinal microbiota. Recent scientific studies show an inverse correlation between the intake of flavonoids in the diet and the incidence of diabetes, such as to hypothesize the use of foods rich in flavonoids as potential food supplements in the management of diabetes. The cocoa flavonoids can bring benefits to the insulin-resistance condition by improving endothelial function, modifying glucose metabolism and reducing oxidative stress, which is considered the main cause of insulin resistance. In healthy individuals and even in patients with moderate cardiovascular risk, regular intake of flavonoids improves levels of cardiovascular biomarkers, reducing serum LDL cholesterol concentrations and triglycerides and increasing HDL cholesterol concentrations. The flavonoids present in cocoa may also inhibit platelet aggregation by down-regulation of the cellular synthesis of eicosanoids. Chocolate is an effective alternative for increasing fiber intake at recommended levels; in addition, it reduces intestinal transit time by increasing peristaltic movements.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

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

入选标准

  • Aged 25-35 years old
  • Able to sign an informed consent

排除标准

  • Refuse to sign an informed consent
  • Diagnosis of organic diseases, including neoplastic inflammatory or cardiovascular diseases
  • Drugs able to influence the gastrointestinal tract or interfering with symptoms
  • Pregnancy
  • Presence of diseases with a prognosis inferior to a year
  • Hypersensitivity to chocolate or its components

研究组 & 干预措施

Healthy

Experimental

10 participants (matched per gender), aged 25-35 years old who accepts the consumption of dark chocolate plus a 'NutriDrink' previous to signing an informed consent and providing authorization to the handling of their personal data

干预措施: Healthy (Dietary Supplement)

结局指标

主要结局

Organoleptic assessment

时间窗: 1 day

All subjects (n=10, matched per gender) will undergo a subjective organoleptic assessment of dark chocolate, based on a standard semi-quantitative scale (ranging 1-5) and a quantitative visual analogue scale (VAS, ranging from 0 to 100 on a horizontal line), to evaluate the visual, auditory, olfactory, gustatory and tactile aspects.

Gastrointestinal motility

时间窗: 1 day

All subjects (n=10, matched per gender) will be assessed for gastrointestinal motility in fasting state to monitor gastric empting, gallbladder empting (ultrasound) and oro-cecal transit time (H 2 lactulose BT), at baseline and at 5 minutes intervals during the firsts 30 minutes, and at 15 minutes intervals during the remaining 90 minutes, for a total of 2 hours of observations.

次要结局

未报告次要终点

研究者

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

piero portincasa

PhD MD Professor Piero Portincasa

University of Bari

研究点 (1)

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