Efficacy of Dark Chocolate in Achalasia Patients

Phase 1

• Conditions: Achalasia
• Interventions: Dietary Supplement: dark chocolate; Dietary Supplement: placebo chocolate with crossover to dark chocolate

• Registration Number: NCT00790465
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-12
• Last Update Submitted: 2008-11-12
• Study First Posted: 2008-11-13
• Last Update Posted: 2008-11-13
• Primary Completion: 2009-11
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	dark chocolate	dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
2	placebo chocolate with crossover to 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.

Primary Outcome Measures

Name	Time	Method
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.	day 1

Secondary Outcome Measures

Name	Time	Method
achalasia symptoms before and during dark-chocolate consumption	2 weeks