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

NCT ID: NCT01391624

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-01-31

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.

Conditions

Addictive Behavior; Abstinence Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Omega 3

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

Group Type: EXPERIMENTAL

Flaxseed oil

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Paraffin + # 2 dye

Intervention Type: DRUG

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

Interventions

Flaxseed oil

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

Intervention Type: DRUG

Paraffin + # 2 dye

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

Intervention Type: DRUG

Other Intervention Names

DHA; EPA; Essential fatty acids; Mineral oil

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Adjunct Professor in the Department of Psychobiology of the Federal University of São Paulo

Principal Investigators

Pedro L Prior, Student

Role: STUDY_CHAIR

Student

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Omega3-chocolate-001

Identifier Type: -

Identifier Source: org_study_id