Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers (OMEGA3CHOCO)

Federal University of São Paulo

Status and phase: Completed; Phase 3; Phase 2

Conditions: Addictive Behavior; Abstinence Syndrome

Treatments: Drug: Flaxseed oil; Drug: Paraffin + # 2 dye

Study type: Interventional

Funder types: Other

Identifiers

NCT01391624

Omega3-chocolate-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Omega 3

Experimental group

Description:

The group was treated with omega 3 fatty acids for 2 months.

Treatment:

Drug: Flaxseed oil

Placebo

Placebo Comparator group

Description:

The group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules.

Treatment:

Drug: Paraffin + # 2 dye