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

NCT01391624 | Completed Phase 2 DMC

• 1 other identifier: Omega3-chocolate-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Addictive Behavior; Abstinence Syndrome

Keywords

chocolate; craving; addiction; compulsion

Outcome Measures

Primary Outcomes (1)

• 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).

  2 months after enrollment

Study Arms (2)

Omega 3

EXPERIMENTAL

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

Drug: Flaxseed oil

Placebo

PLACEBO COMPARATOR

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

Drug: Paraffin + # 2 dye

Interventions

Flaxseed oil DRUG

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

Also known as: DHA, EPA, Essential fatty acids

Omega 3

Paraffin + # 2 dye DRUG

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

Also known as: Mineral oil

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of chocolate compulsion or craving, ECAP score \> 12.

You may not qualify if:

• Psychiatric disease of any sort (by the DSM IV criteria, Use of psychoactive drugs of any sort, BMI \> 25 (kg/m2).

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Behavior, Addictive; Compulsive Behavior

Interventions

Linseed Oil; Fatty Acids, Essential; Paraffin; 2-(2-(2-chloro-3-(2-(3,3-dimethyl-5-sulfo-1-(4-sulfo-butyl)-3H-indol-2-yl)-vinyl)-cyclohex-2-enylidene)-ethylidene)-3,3-dimethyl-1-(4-sulfo-butyl)-2,3-dihydro-1H-indole-5-carboxylic acid; Mineral Oil

Condition Hierarchy (Ancestors)

Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Fatty Acids, Unsaturated; Fatty Acids; Hydrocarbons; Organic Chemicals; Petrolatum

Study Officials

• Pedro L Prior, Student

  Student

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

BR (1)