Efficacy of Dark Chocolate in Achalasia Patients
Primary Purpose
Achalasia
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dark chocolate
placebo chocolate with crossover to dark chocolate
Sponsored by
About this trial
This is an interventional treatment trial for Achalasia focused on measuring achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
1
2
Arm Description
dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
Outcomes
Primary Outcome Measures
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
Secondary Outcome Measures
achalasia symptoms before and during dark-chocolate consumption
Full Information
NCT ID
NCT00790465
First Posted
November 12, 2008
Last Updated
November 12, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00790465
Brief Title
Efficacy of Dark Chocolate in Achalasia Patients
Official Title
Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia
Keywords
achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate
Arm Title
2
Arm Type
Other
Arm Description
placebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
dark chocolate
Other Intervention Name(s)
FruiBel chocolate, Belgium.
Intervention Description
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
Intervention Name(s)
placebo chocolate with crossover to dark chocolate
Other Intervention Name(s)
FruiBel chocolate, Belgium
Intervention Description
Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
Primary Outcome Measure Information:
Title
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
achalasia symptoms before and during dark-chocolate consumption
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Dark Chocolate in Achalasia Patients
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