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

Addictive Behavior Clinical Trial

— OMEGA3CHOCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391624
• Other study ID #: Omega3-chocolate-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 7, 2011
• Last updated: July 11, 2011
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: July 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abstinence Syndrome
• Addictive Behavior
• Behavior, Addictive

Intervention

Drug:
• Flaxseed oil
3 g (3 capsules/day) of flax oil for a period of 8 weeks
• Paraffin + # 2 dye
3 capsules of mineral oil (ineffective) for 8 weeks.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)	São Paulo

Sponsors (4)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No