Efficacy of Dark Chocolate in Achalasia Patients

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Achalasia

Treatments: Dietary Supplement: dark chocolate; Dietary Supplement: placebo chocolate with crossover to dark chocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT00790465

achalasia1

TASMC-08-GR-370-CTIL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: dark chocolate

2

Other group

Description:

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

Treatment:

Dietary Supplement: placebo chocolate with crossover to dark chocolate