Efficacy of Dark Chocolate in Achalasia Patients

November 12, 2008 updated by: Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
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 Names:
  • FruiBel chocolate, Belgium.
Other: 2
placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
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 Names:
  • FruiBel chocolate, Belgium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
achalasia symptoms before and during dark-chocolate consumption
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-08-GR-370-CTIL
  • achalasia1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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