Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers (OMEGA3CHOCO)
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|ClinicalTrials.gov Identifier: NCT01391624|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 12, 2011
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 or disease||Intervention/treatment||Phase|
|Addictive Behavior Abstinence Syndrome||Drug: Flaxseed oil Drug: Paraffin + # 2 dye||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers|
|Study Start Date :||August 2010|
|Primary Completion Date :||January 2011|
|Study Completion Date :||January 2011|
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
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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391624
|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|