Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers (OMEGA3CHOCO)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Addictive Behavior Abstinence Syndrome |
Drug: Flaxseed oil Drug: Paraffin + # 2 dye |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers |
- Changes in the MBES score (used to quantify chocolate compulsion) from baseline. [ Time Frame: 2 months after enrollment ] [ Designated as safety issue: No ]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).
| Enrollment: | 30 |
| Study Start Date: | August 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Omega 3
The group was treated with omega 3 fatty acids for 2 months.
|
Drug: Flaxseed oil
3 g (3 capsules/day) of flax oil for a period of 8 weeks
Other Names:
|
|
Placebo Comparator: Placebo
The group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules.
|
Drug: Paraffin + # 2 dye
3 capsules of mineral oil (ineffective) for 8 weeks.
Other Name: Mineral oil
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clinical diagnosis of chocolate compulsion or craving, ECAP score > 12.
Exclusion Criteria:
- Psychiatric disease of any sort (by the DSM IV criteria, Use of psychoactive drugs of any sort, BMI > 25 (kg/m2).
Contacts and Locations| Brazil | |
| Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology) | |
| São Paulo, Brazil, 04023-062 | |
| Study Chair: | Pedro L Prior, Student | Student |
More Information
No publications provided
| Responsible Party: | José Carlos Fernandes Galduróz, MD, PhD, Adjunct Professor in the Department of Psychobiology of the Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01391624 History of Changes |
| Other Study ID Numbers: | Omega3-chocolate-001 |
| Study First Received: | July 7, 2011 |
| Last Updated: | July 11, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
chocolate craving addiction compulsion |
Additional relevant MeSH terms:
|
Behavior, Addictive Compulsive Behavior Impulsive Behavior Mineral Oil |
Emollients Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013