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

Tracking Information
First Received Date ^ICMJE	November 12, 2008
Last Updated Date	November 12, 2008
Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 12, 2008)	Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 12, 2008)	achalasia symptoms before and during dark-chocolate consumption [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy of Dark Chocolate in Achalasia Patients
Official Title ^ICMJE	Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Achalasia
Intervention ^ICMJE	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. 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
Study Arm (s)	Active Comparator: 1 dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate Intervention: Dietary Supplement: dark chocolate 2 placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks. Intervention: Dietary Supplement: placebo chocolate with crossover to dark chocolate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	November 2010
Estimated Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00790465
Other Study ID Numbers ^ICMJE	TASMC-08-GR-370-CTIL, achalasia1
Has Data Monitoring Committee	No
Responsible Party	Dr. Guy Rosner, gastroenterologist, Tel-Aviv Sourasky Medical Center
Study Sponsor ^ICMJE	Tel-Aviv Sourasky Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tel-Aviv Sourasky Medical Center
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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