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Efficacy of Dark Chocolate in Achalasia Patients

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00790465
Collaborator
(none)
40
Enrollment
2
Arms
24
Duration (Months)

Study Details

Study Description

Brief Summary

Flavanols, present in dark chocolate, were shown to induce Nitric Oxide synthesis. Since Nitric Oxide facilitates smooth muscle relaxation, it might ease the relaxation of the LES (lower esophageal sphincter)as well.

The objective of the present study is to evaluate tha efficacy of dark chocolate in improving LES relaxation in achalasia patients.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: dark chocolate
  • Dietary Supplement: placebo chocolate with crossover to dark chocolate
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study
Study Start Date :
Nov 1, 2008
Anticipated Primary Completion Date :
Nov 1, 2009
Anticipated Study Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate

Dietary Supplement: dark chocolate
21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.
Other Names:
  • FruiBel chocolate, Belgium.

    		•
    Other: 2

    placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.

    Dietary Supplement: placebo chocolate with crossover to dark chocolate
    Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
    Other Names:
  • FruiBel chocolate, Belgium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [day 1]

    Secondary Outcome Measures

    1. achalasia symptoms before and during dark-chocolate consumption [2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • clinical diagnosis of "achalasia"

    • "Achalasia" diagnosis during manometry at day 1 of the study.

    Exclusion Criteria:

    • pregnancy

    • pseudoachalasia

    • consumption of GI-motility modifiers durin 72 hours preceding the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00790465
    Other Study ID Numbers:
    • TASMC-08-GR-370-CTIL
    • achalasia1
    First Posted:
    Nov 13, 2008
    Last Update Posted:
    Nov 13, 2008
    Last Verified:
    Nov 1, 2008
    Keywords provided by , ,
    achalasia
    lower esophageal sphincter
    nitric oxide
    dark chocolate
    flavanols
    Additional relevant MeSH terms:
    Esophageal Achalasia

    Study Results

    No Results Posted as of Nov 13, 2008