Efficacy of Dark Chocolate in Achalasia Patients
Recruitment status was: Not yet recruiting
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.
|Achalasia||Dietary Supplement: dark chocolate Dietary Supplement: placebo chocolate with crossover to dark chocolate||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study|
- Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. [ Time Frame: day 1 ]
- achalasia symptoms before and during dark-chocolate consumption [ Time Frame: 2 weeks ]
|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)|
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 Name: FruiBel chocolate, Belgium.
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 Name: FruiBel chocolate, Belgium