Efficacy of Dark Chocolate in Achalasia Patients - Full Text View

Sponsored by:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00790465

Purpose

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.

Condition	Intervention	Phase
Achalasia	Dietary Supplement: dark chocolate Dietary Supplement: placebo chocolate with crossover to dark chocolate	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Esophagus Disorders

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

achalasia symptoms before and during dark-chocolate consumption [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Tel-Aviv Sourasky Medical Center ( Dr. Guy Rosner, gastroenterologist )
Study ID Numbers:	TASMC-08-GR-370-CTIL, achalasia1
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790465 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

achalasia
lower esophageal sphincter
nitric oxide
dark chocolate
flavanols

Study placed in the following topic categories:

Nitric Oxide
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Esophageal Achalasia
Esophageal Diseases
Cardiospasm
Achalasia

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Achalasia
Esophageal Diseases

ClinicalTrials.gov processed this record on September 10, 2009