Addictive BehaviorPhase 2/3OMEGA3CHOCONCT01391624
Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
A Phase 2/3 study testing Flaxseed oil and Paraffin + # 2 dye in people with Addictive Behavior and Abstinence Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether essential polyunsaturated acids (omega 3) are capable of reducing chocolate craving symptoms in healthy patients. Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize neuronal functioning in many conditions, including chocolate… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Addictive Behavior, Abstinence Syndrome
- What is being tested?
- Flaxseed oil and Paraffin + # 2 dye
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Jan 2011
- Phase
- Phase 2/3
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of chocolate compulsion or craving, ECAP score > 12.
Who cannot join
- Psychiatric disease of any sort (by the DSM IV criteria, Use of psychoactive drugs of any sort, BMI > 25 (kg/m2).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)
São Paulo, São Paulo, 04023-062
About this study
The purpose of this study is to determine whether essential polyunsaturated acids (omega 3) are capable of reducing chocolate craving symptoms in healthy patients.
Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize neuronal functioning in many conditions, including chocolate craving.
Read the detailed description
Polyunsaturated fatty acids (of the omega 3 subtype) are fundamental in human diet, as they are components of cellular membranes, guaranteeing their fluidity and their functions of separating intracellular and extracellular means and transporting several substances to and from cellular microenvironment.
Modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of several deletery changes in neuronal physiology, which may cause or make worse several pathological conditions, such as depression, mood instability, and drug craving. The role of serotonin as the main lacking component in the conditions is well documented, and it is thought that omega 3 is important in the synthesis, transportation, and ultimately the activity of this neurotransmitter.
Out theory states that supplementation with these acids can restore normal neuron balance, improving the condition of chocolate craving patients.
- Conditions
- Addictive Behavior, Abstinence Syndrome
- Being tested
- Flaxseed oil, Paraffin + # 2 dye
- Keywords
- chocolate, craving, addiction, compulsion
- Medical subject headings
- Behavior, Addictive, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed oilDrug
Also called DHA, EPA, Essential fatty acids
3 g (3 capsules/day) of flax oil for a period of 8 weeks
Paraffin + # 2 dyeDrug
Also called Mineral oil
3 capsules of mineral oil (ineffective) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 | Experimental | The group was treated with omega 3 fatty acids for 2 months. Receives: Drug: Flaxseed oil |
| Placebo | Placebo comparator | The group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules. Receives: Drug: Paraffin + # 2 dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the MBES score (used to quantify chocolate compulsion) from baseline.
The MBES is an objective scale used to quantify compulsion and classify chocolate cravers in three categories: low, moderate and severe cravers. The scale was applied to all volunteers at baseline and 2 months after enrollment in the study, and comparisons were made to establish if there was efficacy of treatment with omega 3 when compared with placebo (with decreased grades in the MBES scale).
Measured: 2 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addictive BehaviorStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Pedro L Prior, Student, Study chair, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391624
- Sponsor's protocol ID
- Omega3-chocolate-001
- Acronym
- OMEGA3CHOCO
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
- ClinicalTrials.gov ID
- NCT01391624
- Acronym / sponsor ID
- OMEGA3CHOCO / Omega3-chocolate-001
- Conditions
- Addictive Behavior, Abstinence Syndrome
- Keywords
- chocolate, craving, addiction, compulsion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Jul 2011 (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.
The purpose of this study is to determine whether essential polyunsaturated acids (omega 3) are capable of reducing chocolate craving symptoms in healthy patients.
Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize neuronal functioning in many conditions, including chocolate craving.
Detailed description
Polyunsaturated fatty acids (of the omega 3 subtype) are fundamental in human diet, as they are components of cellular membranes, guaranteeing their fluidity and their functions of separating intracellular and extracellular means and transporting several substances to and from cellular microenvironment.
Modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of several deletery changes in neuronal physiology, which may cause or make worse several pathological conditions, such as depression, mood instability, and drug craving. The role of serotonin as the main lacking component in the conditions is well documented, and it is thought that omega 3 is important in the synthesis, transportation, and ultimately the activity of this neurotransmitter.
Out theory states that supplementation with these acids can restore normal neuron balance, improving the condition of chocolate craving patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 | Experimental | Drug: Flaxseed oilThe group was treated with omega 3 fatty acids for 2 months. |
| Placebo | Placebo comparator | Drug: Paraffin + # 2 dyeThe group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chocolate compulsion or craving, ECAP score > 12.
Key exclusion criteria (1 listed)
- Psychiatric disease of any sort (by the DSM IV criteria, Use of psychoactive drugs of any sort, BMI > 25 (kg/m2).
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 |
|---|---|---|
| Flaxseed oilAlso: DHA, EPA, Essential fatty acids3 g (3 capsules/day) of flax oil for a period of 8 weeks | Drug | Omega 3 |
| Paraffin + # 2 dyeAlso: Mineral oil3 capsules of mineral oil (ineffective) for 8 weeks. | Drug | Placebo |
Primary outcome
Changes in the MBES score (used to quantify chocolate compulsion) from baseline.
Time frame: 2 months after enrollment
The MBES is an objective scale used to quantify compulsion and classify chocolate cravers in three categories: low, moderate and severe cravers. The scale was applied to all volunteers at baseline and 2 months after enrollment in the study, and comparisons were made to establish if there was efficacy of treatment with omega 3 when compared with placebo (with decreased grades in the MBES scale).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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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.
Pedro L Prior, Student study chair
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Flaxseed oil and Paraffin + # 2 dye in people with Addictive Behavior and Abstinence Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the MBES score (used to quantify chocolate compulsion) from baseline. (time frame: 2 months after enrollment). 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 12 Jul 2011.