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

July 11, 2011 updated by: Federal University of São Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04023-062
        • Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • DHA
  • EPA
  • Essential fatty acids
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 Names:
  • Mineral oil

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

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

Investigators

  • Study Chair: Pedro L Prior, Student, Student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omega3-chocolate-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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