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

This study has been completed.
Sponsor:
Collaborators:
Associação Fundo de Incentivo à Pesquisa
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01391624
First received: July 7, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Addictive Behavior
Abstinence Syndrome
Drug: Flaxseed oil
Drug: Paraffin + # 2 dye
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Changes in the MBES score (used to quantify chocolate compulsion) from baseline. [ Time Frame: 2 months after enrollment ] [ Designated as safety issue: No ]
    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).


Enrollment: 30
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mineral oil

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391624

Locations
Brazil
Universidade Federal de São Paulo (Federal University of São Paulo); Departamento de Psicobiologia (Department of Psychobiology)
São Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Associação Fundo de Incentivo à Pesquisa
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Chair: Pedro L Prior, Student Student
  More Information

No publications provided

Responsible Party: José Carlos Fernandes Galduróz, MD, PhD, Adjunct Professor in the Department of Psychobiology of the Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01391624     History of Changes
Other Study ID Numbers: Omega3-chocolate-001
Study First Received: July 7, 2011
Last Updated: July 11, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
chocolate
craving
addiction
compulsion

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Mineral Oil
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014