AchalasiaPhase 1/2NCT00790465
Efficacy of Dark Chocolate in Achalasia Patients
A Phase 1/2 study testing dark chocolate in people with Achalasia, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- dark chocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Nov 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of "achalasia"
- "Achalasia" diagnosis during manometry at day 1 of the study.
Who cannot join
- pregnancy
- pseudoachalasia
- consumption of GI-motility modifiers durin 72 hours preceding the study.
About this study
Official title: 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.
- Conditions
- Achalasia
- Being tested
- dark chocolate, placebo chocolate with crossover to dark chocolate
- Keywords
- achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dark chocolateDietary supplement
Also called FruiBel chocolate, Belgium.
21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry.
placebo chocolate with crossover to dark chocolateDietary supplement
Also called FruiBel chocolate, Belgium
Placebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | dark chocolate consumption during manometry and 2 weeks treatment with dark chocolate Receives: 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. Receives: Dietary Supplement: placebo chocolate with crossover to dark chocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
Measured: day 1
Secondary outcomes (1)
achalasia symptoms before and during dark-chocolate consumption
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790465
- Sponsor's protocol ID
- TASMC-08-GR-370-CTIL
- Other IDs
- achalasia1
- Status last verified
- Nov 2008
- First submitted
- 12 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dark Chocolate in Achalasia Patients: Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00790465
- Acronym / sponsor ID
- TASMC-08-GR-370-CTIL
- Conditions
- Achalasia
- Keywords
- achalasia, lower esophageal sphincter, nitric oxide, dark chocolate, flavanols
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: dark chocolatedark chocolate consumption during manometry and 2 weeks treatment with dark chocolate |
| 2 | Other | Dietary Supplement: placebo chocolate with crossover to dark chocolateplacebo comparator: 7 grams of placebo-chocolate at day 1 during manometry, and than crossover to treatment with dark chocolate for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of "achalasia"
- "Achalasia" diagnosis during manometry at day 1 of the study.
Key exclusion criteria (3 listed)
- pregnancy
- pseudoachalasia
- consumption of GI-motility modifiers durin 72 hours preceding the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dark chocolateAlso: FruiBel chocolate, Belgium.21 g/d of dark chocolate for 2 weeks (7 g. before each meal). 7 grams of dark chocolate at day 1 during manometry. | Dietary supplement | 1 |
| placebo chocolate with crossover to dark chocolateAlso: FruiBel chocolate, BelgiumPlacebo at day 1 during manometry, and than crossover to dark chocolate for 2 weeks treatment. | Dietary supplement | 2 |
Primary outcome
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption.
Time frame: day 1
1 secondary outcome
achalasia symptoms before and during dark-chocolate consumption
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dark chocolate in people with Achalasia, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Esophageal Sphincter relaxation before and after dark chocolate consumption. (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2008.