Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers

NCT01391624 — Phase 2 / Phase 3, Completed, 30 participants, Federal University of São Paulo

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Registry	NCT01391624, acronym OMEGA3CHOCO
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	30 (Actual)
Sponsor	Federal University of São Paulo (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
Conditions	Addictive Behavior, Abstinence Syndrome
Interventions	Flaxseed oil, Paraffin + # 2 dye (Drug)
Dates	start 2010-08-01, primary completion 2011-01-01, completion 2011-01-01, first posted 2011-07-12, last updated 2011-07-12
Locations	1 site in Brazil

-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 craving.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Omega 3	Experimental	Drug: Flaxseed oil	The group was treated with omega 3 fatty acids for 2 months.
Placebo	Placebo comparator	Drug: Paraffin + # 2 dye	The group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules.

Flaxseed oil (Drug), also known as DHA, EPA, Essential fatty acids: 3 g (3 capsules/day) of flax oil for a period of 8 weeks
Paraffin + # 2 dye (Drug), also known as Mineral oil: 3 capsules of mineral oil (ineffective) for 8 weeks.

+Outcome measures

Primary outcomes

Changes in the MBES score (used to quantify chocolate compulsion) from baseline. [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).

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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).

+Locations (1)

Facility	City	Country	Status
Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)	São Paulo, São Paulo	Brazil

+Investigators

Pedro L Prior, Student, Study chair, Student