Dark Chocolate and Intestinal Motility

NCT03841578 | Unknown

• 1 other identifier: 1519UO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Motility

Keywords

Dark chocolate, gastrointestinal motility

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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

Dietary Supplement: Healthy

Interventions

Healthy DIETARY_SUPPLEMENT

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

Healthy

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"

Bari, BA, 70124, Italy

Location

Related Publications (9)

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

  PMID: 23462053 BACKGROUND

• 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.

  PMID: 29181133 BACKGROUND

• 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. doi: 10.1073/pnas.0510168103. Epub 2006 Jan 17.

  PMID: 16418281 BACKGROUND

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

  PMID: 16548143 BACKGROUND

• 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. doi: 10.1093/jn/138.4.725.

  PMID: 18356327 BACKGROUND

• Hayek N. Chocolate, gut microbiota, and human health. Front Pharmacol. 2013 Feb 7;4:11. doi: 10.3389/fphar.2013.00011. eCollection 2013. No abstract available.

  PMID: 23405053 BACKGROUND

• Davinelli S, Corbi G, Righetti S, Sears B, Olarte HH, Grassi D, Scapagnini G. Cardioprotection by Cocoa Polyphenols and omega-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.

  PMID: 29723102 BACKGROUND

• Mushref MA, Srinivasan S. Effect of high fat-diet and obesity on gastrointestinal motility. Ann Transl Med. 2013 Jul 1;1(2):14. doi: 10.3978/j.issn.2305-5839.2012.11.01.

  PMID: 24432301 BACKGROUND

• 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.

  PMID: 22497555 BACKGROUND

Study Officials

• Piero Portincasa, MD, PhD

  Clinica Medica "A. Murri", DIMO - University of Bari

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Portincasa, MD, PhD

CONTACT

+393284687215; piero.portincasa@uniba.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD Professor Piero Portincasa

Model Details: 10 healthy subjects (controls) undergoing organoleptic assessment and gastrointestinal motility study

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

IT (1)