NCT00790465

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2008

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

November 12, 2008

Last Update Submit

November 12, 2008

Conditions

Achalasia

Keywords

achalasialower esophageal sphincternitric oxidedark chocolateflavanols

Outcome Measures

Primary Outcomes (1)

  • Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.

    day 1

Secondary Outcomes (1)

  • achalasia symptoms before and during dark-chocolate consumption

    2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: dark chocolate

2

OTHER

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

Interventions

dark chocolateDIETARY_SUPPLEMENT

21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.

Also known as: FruiBel chocolate, Belgium.
1
placebo chocolate with crossover to dark chocolateDIETARY_SUPPLEMENT

Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.

Also known as: FruiBel chocolate, Belgium
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of "achalasia"
  • "Achalasia" diagnosis during manometry at day 1 of the study.

You may not qualify if:

  • pregnancy
  • pseudoachalasia
  • consumption of GI-motility modifiers durin 72 hours preceding the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

November 13, 2008

Record last verified: 2008-11