Efficacy of Dark Chocolate in Achalasia Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00790465
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 12, 2008
November 12, 2008
November 2008
November 2009   (final data collection date for primary outcome measure)
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
achalasia symptoms before and during dark-chocolate consumption [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Dark Chocolate in Achalasia Patients
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Achalasia
  • 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 Name: FruiBel chocolate, Belgium.
  • 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 Name: FruiBel chocolate, Belgium
  • Active Comparator: 1
    dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
    Intervention: Dietary Supplement: dark chocolate
  • 2
    placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
    Intervention: Dietary Supplement: placebo chocolate with crossover to dark chocolate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
November 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Not Provided
 
NCT00790465
TASMC-08-GR-370-CTIL, achalasia1
No
Dr. Guy Rosner, gastroenterologist, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP