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

Primary Purpose

Addictive Behavior, Abstinence Syndrome

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Flaxseed oil
Paraffin + # 2 dye
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addictive Behavior focused on measuring chocolate, craving, addiction, compulsion

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega 3

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 7, 2011
Last Updated
July 11, 2011
Sponsor
Federal University of São Paulo
Collaborators
Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01391624
Brief Title
Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
Acronym
OMEGA3CHOCO
Official Title
Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Associação Fundo de Incentivo à Pesquisa, Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addictive Behavior, Abstinence Syndrome
Keywords
chocolate, craving, addiction, compulsion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega 3
Arm Type
Experimental
Arm Description
The group was treated with omega 3 fatty acids for 2 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The group received paraffin with dye in order to mimic the visual aspects of omega 3 fatty acid capsules.
Intervention Type
Drug
Intervention Name(s)
Flaxseed oil
Other Intervention Name(s)
DHA, EPA, Essential fatty acids
Intervention Description
3 g (3 capsules/day) of flax oil for a period of 8 weeks
Intervention Type
Drug
Intervention Name(s)
Paraffin + # 2 dye
Other Intervention Name(s)
Mineral oil
Intervention Description
3 capsules of mineral oil (ineffective) for 8 weeks.
Primary Outcome Measure Information:
Title
Changes in the MBES score (used to quantify chocolate compulsion) from baseline.
Description
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).
Time Frame
2 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro L Prior, Student
Organizational Affiliation
Student
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

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

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