Efficacy of Dark Chocolate in Achalasia Patients

Achalasia Clinical Trial

Official title:

Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00790465
• Other study ID #: TASMC-08-GR-370-CTIL
• Secondary ID: achalasia1
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 12, 2008
• Last updated: November 12, 2008
• Start date: November 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

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.
• placebo chocolate with crossover to dark chocolate
Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.		day 1	No
Secondary	achalasia symptoms before and during dark-chocolate consumption		2 weeks	No