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Efficacy of Dark Chocolate in Achalasia Patients

Primary Purpose

Achalasia

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dark chocolate
placebo chocolate with crossover to dark chocolate
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    1

    2

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.

    Secondary Outcome Measures

    achalasia symptoms before and during dark-chocolate consumption

    Full Information

    First Posted
    November 12, 2008
    Last Updated
    November 12, 2008
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00790465
    Brief Title
    Efficacy of Dark Chocolate in Achalasia Patients
    Official Title
    Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    November 2009 (Anticipated)
    Study Completion Date
    November 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Achalasia
    Keywords
    achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
    Arm Title
    2
    Arm Type
    Other
    Arm Description
    placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    dark chocolate
    Other Intervention Name(s)
    FruiBel chocolate, Belgium.
    Intervention Description
    21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo chocolate with crossover to dark chocolate
    Other Intervention Name(s)
    FruiBel chocolate, Belgium
    Intervention Description
    Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
    Primary Outcome Measure Information:
    Title
    Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
    Time Frame
    day 1
    Secondary Outcome Measure Information:
    Title
    achalasia symptoms before and during dark-chocolate consumption
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Efficacy of Dark Chocolate in Achalasia Patients

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