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Efficacy of Dark Chocolate in Achalasia Patients

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ClinicalTrials.gov Identifier: NCT00790465
Recruitment Status : Unknown
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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
Achalasia Dietary Supplement: dark chocolate Dietary Supplement: placebo chocolate with crossover to dark chocolate Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: FruiBel chocolate, Belgium.
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 Name: FruiBel chocolate, Belgium



Primary Outcome Measures :
  1. Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. achalasia symptoms before and during dark-chocolate consumption [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Dr. Guy Rosner, gastroenterologist, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00790465     History of Changes
Other Study ID Numbers: TASMC-08-GR-370-CTIL
achalasia1
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
achalasia
lower esophageal sphincter
nitric oxide
dark chocolate
flavanols

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases