Clinical trial NCT03841578: Dark Chocolate and Intestinal Motility
Official title: Effects of Dark Chocolate on Gastrointestinal Motility in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Motility
Keywords: Dark chocolate, gastrointestinal motility
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 10 healthy subjects (controls) undergoing organoleptic assessment and gastrointestinal motility study
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Organoleptic assessment
timeFrame: 1 day
measure: Gastrointestinal motility
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"
state: BA
Study officials:
affiliation: Clinica Medica "A. Murri", DIMO - University of Bari
name: Piero Portincasa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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