Gastrointestinal Motility Clinical Trial
— CHOCO-motOfficial title:
Effects of Dark Chocolate on Gastrointestinal Motility in Healthy Subjects
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri" | Bari | BA |
Lead Sponsor | Collaborator |
---|---|
University of Bari |
Italy,
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
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 |
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