Dark Chocolate and Intestinal Motility

Gastrointestinal Motility Clinical Trial

— CHOCO-mot  

Official title:

Effects of Dark Chocolate on Gastrointestinal Motility in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03841578
• Other study ID #: 1519UO
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: February 2019
• Source: University of Bari
• Contact: Piero Portincasa, MD, PhD
• Phone: +393284687215
• Email: piero.portincasa[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 1, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Motility

Intervention

Dietary Supplement:
• Healthy
25g of dark chocolate (70%) will be provided to participants on Phase 1 (organoleptic assessment). On Phase 2 (gastrointestinal motility assessment), they will ingest a standard liquid meal (NutriDrink, 200ml), consisting of 10g of lactulose and 12g of fat

Locations

Country	Name	City	State
Italy	Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"	Bari	BA

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Allen RR, Carson L, Kwik-Uribe C, Evans EM, Erdman JW Jr. Daily consumption of a dark chocolate containing flavanols and added sterol esters affects cardiovascular risk factors in a normotensive population with elevated cholesterol. J Nutr. 2008 Apr;138(4):725-31. — View Citation

Davinelli S, Corbi G, Righetti S, Sears B, Olarte HH, Grassi D, Scapagnini G. Cardioprotection by Cocoa Polyphenols and ?-3 Fatty Acids: A Disease-Prevention Perspective on Aging-Associated Cardiovascular Risk. J Med Food. 2018 Oct;21(10):1060-1069. doi: 10.1089/jmf.2018.0002. Epub 2018 May 3. Review. — View Citation

Di Ciaula A, Wang DQ, Portincasa P. Gallbladder and gastric motility in obese newborns, pre-adolescents and adults. J Gastroenterol Hepatol. 2012 Aug;27(8):1298-305. doi: 10.1111/j.1440-1746.2012.07149.x. — View Citation

Hayek N. Chocolate, gut microbiota, and human health. Front Pharmacol. 2013 Feb 7;4:11. doi: 10.3389/fphar.2013.00011. eCollection 2013. — View Citation

Latif R. Chocolate/cocoa and human health: a review. Neth J Med. 2013 Mar;71(2):63-8. Review. — View Citation

Mushref MA, Srinivasan S. Effect of high fat-diet and obesity on gastrointestinal motility. Ann Transl Med. 2013 Jul 1;1(2):14. — View Citation

Schroeter H, Heiss C, Balzer J, Kleinbongard P, Keen CL, Hollenberg NK, Sies H, Kwik-Uribe C, Schmitz HH, Kelm M. (-)-Epicatechin mediates beneficial effects of flavanol-rich cocoa on vascular function in humans. Proc Natl Acad Sci U S A. 2006 Jan 24;103(4):1024-9. Epub 2006 Jan 17. — View Citation

Shah SR, Alweis R, Najim NI, Dharani AM, Jangda MA, Shahid M, Kazi AN, Shah SA. Use of dark chocolate for diabetic patients: a review of the literature and current evidence. J Community Hosp Intern Med Perspect. 2017 Sep 19;7(4):218-221. doi: 10.1080/20009666.2017.1361293. eCollection 2017 Oct. Review. — View Citation

Ueshima K. Magnesium and ischemic heart disease: a review of epidemiological, experimental, and clinical evidences. Magnes Res. 2005 Dec;18(4):275-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organoleptic assessment	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.	1 day
Primary	Gastrointestinal motility	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.	1 day