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Sponsored by: |
Tel-Aviv Sourasky Medical Center |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00790465 |
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 |
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Achalasia |
Dietary Supplement: dark chocolate Dietary Supplement: placebo chocolate with crossover to dark chocolate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study |
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 |
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1: Active Comparator
dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
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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.
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placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Tel-Aviv Sourasky Medical Center ( Dr. Guy Rosner, gastroenterologist ) |
Study ID Numbers: | TASMC-08-GR-370-CTIL, achalasia1 |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790465 |
Health Authority: | Israel: Ministry of Health |
achalasia lower esophageal sphincter nitric oxide dark chocolate flavanols |
Nitric Oxide Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Esophageal Achalasia Esophageal Diseases Cardiospasm Achalasia |