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OpenTrials
Completed

NCT Number: NCT01391624

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

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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Key information

Conditions

Addictive Behavior Abstinence Syndrome Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)

São Paulo, 04023-062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Flaxseed oil

Drug

3 g (3 capsules/day) of flax oil for a period of 8 weeks

Other names: DHA, EPA, Essential fatty acids

Paraffin + # 2 dye

Drug

3 capsules of mineral oil (ineffective) for 8 weeks.

Other names: Mineral oil

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Associação Fundo de Incentivo à Pesquisa
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: OMEGA3CHOCO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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