Efficacy of Dark Chocolate in Achalasia Patients

NCT ID: NCT00790465

Last Updated: 2008-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Achalasia

Keywords

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achalasia lower esophageal sphincter nitric oxide dark chocolate flavanols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate

Group Type ACTIVE_COMPARATOR

dark chocolate

Intervention Type DIETARY_SUPPLEMENT

21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.

2

placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.

Group Type OTHER

placebo chocolate with crossover to dark chocolate

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FruiBel chocolate, Belgium. FruiBel chocolate, Belgium

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Other Identifiers

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achalasia1

Identifier Type: -

Identifier Source: secondary_id

TASMC-08-GR-370-CTIL

Identifier Type: -

Identifier Source: org_study_id