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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


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
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