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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Addictive Behavior, Abstinence Syndrome

Intervention / Treatment
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* Drug: Flaxseed oil
* Drug: Paraffin + # 2 dye


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3<br>The group was treated with omega 3 fatty acids for 2 months. | Drug: Flaxseed oil<br>* 3 g (3 capsules/day) of flax oil for a period of 8 weeks<br>* Other names: Essential fatty acids;|
| Placebo Comparator: Placebo<br>The group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules. | Drug: Paraffin + # 2 dye<br>* 3 capsules of mineral oil (ineffective) for 8 weeks.<br>* Other names: Mineral oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chocolate, craving, addiction, compulsion