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Efficacy of Dark Chocolate in Achalasia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00790465
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • achalasia symptoms before and during dark-chocolate consumption [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: November 12, 2008
Last Updated: November 12, 2008
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013