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Effects of supplementation with flaxseed oil on chocolate craving: a pilot randomized placebo-controlled study




Pedro Luis Prior*, Anna Carolina Ramos**, Jaqueline Kalleian Eserian**, Ju�ara
Zaparoli****, Jos� Carlos Fernandes Galdur�zc



*MD, Department of Medicine, Universidade Federal de S�o Paulo. R. Pedro de
Toledo, 720, Vila Clementino. Zip code: 04039-002 - S�o Paulo, SP. Brazil.

**MSc, Department of Psychobiology, , Universidade Federal de S�o Paulo. R.
Napole�o de Barros, 925. Vila Clementino. Zip code: 04024-002 - S�o Paulo,
SP. Brazil.

** MSc, Department of Psychobiology, Universidade Federal de S�o Paulo. R.
Napole�o de Barros, 925. Vila Clementino. Zip code: 04024-002 - S�o Paulo,
SP. Brazil.

**** MSc, Department of Psychobiology, Universidade Federal de S�o Paulo. R.
Napole�o de Barros, 925. Vila Clementino. Zip code: 04024-002 - S�o Paulo,
SP. Brazil.

C � corresponding author: MD, PhD, Adjunct professor at the Department of
Psychobiology, , Universidade Federal de S�o Paulo R. Napole�o de Barros,
925. Vila Clementino. Zip code: 04024-002 -. S�o Paulo, SP. Brazil email:
 HYPERLINK "mailto:galduroz@unifesp.br" galduroz@unifesp.br.


Acknowledgments: Funda��o de Amparo � Pesquisa do Estado de S�o Paulo (FAPESP), Associa��o Fundo de Incentivo � Pesquisa (AFIP), Conselho Nacional de Desenvolvimento e Tecnol�gico (CNPq), who offered grants to the main author and the reserach team as a whole. 






Abstract


Background: Chocolate craving is a recognized health problem that is very prevalent is all medical scenarios. There are very few studies that have searched for a pharmacological agent that can mitigate this problem.

Methods: Double blind, placebo-controlled trial, N= 30 subjects who were considered �chocolate cravers� by clinical assessment by the Modified Binge Eating Scale: the experimental group (N=15) received 3 g/day of flaxseed oil for two months. The dropout rate was 16.6% (N=5).The remaining volunteers were entirely of female gender. The flaxseed oil has a ratio of omega 3 and omega 6 concentration of 4:1. Chocolate consumption (in grams) was determined before and after supplementation.

Results: There was significant difference between the MBES score before and after the treatment, only in the test group (post hoc Newman-Keuls p<0.001), as well as a significant decrease in chocolate consumption � measured in grams (Student t test, p=0.03).

Conclusion: The results show a possible approach of treatment for craving for chocolate consumption.


Clinical Trials registration: NCT01391624 (OMEGA3CHOCO)
https://clinicaltrials.gov/ct2/show/NCT01391624?term=NCT01391624&rank=1


Keywords: chocolate, compulsion, flaxseed oil, treatment.






Introduction

Chocolate is recognized as a food with many psychoactive components (cannabinoid-like molecules, methylxanthines, long-chain carboxylic acids, and other factors) which activate, directly and indirectly, and for short periods of time, the serotoninergic system of the pre-frontal cortex, and, more importantly, the reward pathways [1]. Its consumption is referred by its own users as �druglike�, and compulsive symptoms of chocolate cravers have been taken into account in several studies � generalized anxiety when not in use, guilt over consumption � which relate to manifestations of drug-dependent patients in withdrawal and other food-related cravers [2,3]. It is important to stress that chocolate craving is a problem in itself for many patients, and any possible therapies that can relieve their suffering are worth investigating [1]. 

Evidence suggests that many neural pathways are involved in craving, especially serotoninergic, dopaminergic and opiodergic pathways, derived from several areas (prefrontal cortex, amygdala and hippocampus) [4,5]. There are still no specific treatments for craving symptoms; however certain attempts using omega 3 fatty acid containing products, in clinical trials, for drug dependent patients have shown success in reducing subjective symptoms such as pain and individual suffering, as well as reducing the number of relapses in these groups [6-10]. 

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 [1, 11-14]. Modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of several and deletery changes in neuronal physiology, which may cause or make worse several pathological conditions, such as depression, mood instability, and drug craving [14-17]. The role of serotonin as the main lacking component in the conditions is well documented, and it is supposed that omega 3 is important in the synthesis, transportation, and ultimately the activity of this neurotransmitter [14].

Flaxseed oil is a reliable source of both omega 3 and omega 6 fatty acids, and has been established as a reliable source of fatty acid supplementation, with better gastric tolerability and lower incidence of allergic reactions in patients when compared with fish oil [18-20]. The objective of this study was to determine if daily dietary supplementation with flaxseed was successful in mitigating craving symptoms in chocolate craving volunteers.


Methods and Material

This is a randomized, double-blind, placebo-controlled trial involving a total of 30 volunteers (N=30), divided into two groups: the placebo group received capsules containing a formula of paraffin and # 2 dye, simulating the visual aspects of fatty acids, and the experimental group received capsules containing 1000 mg of flaxseed oil, in the proportion of omega 3: omega 6 (4:1), respectively. The period of intervention was 2 months, and volunteers were instructed to take 3 capsules daily, divided TID.

In order to obtain objective data about craving symptoms, we used a modified analytic instrument: the Binge Eating Scale originally developed by Gormally, Black, Daston and Rardin in 1982 [21] and translated to portuguese by Freitas, Lopes, Coutinhob and Appolinario in 2001 [22]. The grammatical and semantical structure of the questions were maintained, and questions that were designed for detecting patients with other psychiatric disorders similar to binge eating disorder (bulimia nervosa, anorexia nervosa, psychological faking), and also the ones who referred to habitual meals of the interview patient were eliminated. The following questions of the original test were maintained: 2,3,4,5,6,10,11,12,14,15,16. The instrument was still able, despite our adaptation, to divide compulsion in three categories: typical behavior manifestations (shame and social isolation), subjective feelings in regard to daily consumption of chocolate, and frequency and amount of chocolate consumption. 

Every question was multiple-choice and self-reported, with 3 to 4 different options each, and total scores were related to different states: score of less than 17 was correlated with minimal or non-existent chocolate compulsion, scores between 18 and 26 were classified as moderate craving, and scores greater than 27 were classified as severe craving. Volunteers who scored more than 18 were invited to take part in the project. The modified binge eating scale (MBES) was applied in the initial consultation for gathering data on volunteers, and on the final consultation after 2 months of supplementation.

Inclusion criteria: Volunteers of both genders, age between 18 and 45 years, body mass index (BMI) between 18.5 kg/m2 and 26.0 kg/m2, with MBES scale greater than 18 were considered for participation.

Exclusion criteria: Volunteers diagnosed (according to DSM IV criteria American Psychiatric Association in 2004 [23]) with any psychiatric condition, or taking any psychoactive medication. Volunteers taking any recreational drugs, legal or illegal, were excluded. 

We applied the Beck Depression Inventory and Beck Anxiety Inventory, developed by Beck and Steer in 1961 [24,25], because these symptoms usually relate as both cause and consequence of excessive consumption of chocolate and other foods [24] .Any volunteer who scored enough to be qualified as moderate depressed or moderately anxious was excluded.

Ethical aspects: The project was submitted and approved by the research ethics committee (CEP), under the registration number 0695/10. We obtained informed consent from all participants, according to federal norms: 196/96 e 251/97, from the national council in health. Statistical analyses: We analyzed data with t student test. The level of significance was p < 0.05 for all analysis.


Results

Our sample initially consisted of 29 females and 1 male, which excluded in our analysis to avoid gender bias (mean age 30.3 years). Five volunteers abandoned the study for personal reasons (3 from the placebo group and 2 from the experimental group), not related to the experiment itself, to side effects of the drugs or any other difficulties. The only side effects the experimental group members referred fish taste in mouth in beginning of treatment and lose stools in the first days of supplementation. There were no significant statistical differences, before the intervention, between the placebo or experimental groups concerning the following parameters: BMI, age, and initial MBES score (Table 1).

After the 2 month trial, there was significant difference between the MBES scores of the experimental and placebo groups (t student Test; p<0.001) [Figure 1]. In the experimental group, there was significant difference between the MBES score before and after the treatment as well as a significant decrease in chocolate consumption � measured in grams (Student t test, p=0.03).


Discussion


Our results show decrease in total chocolate consumption as well as decrease in craving scores and symptoms only in flaxseed oil experimental group. These results are consistent with other studies which relate polyunsaturated fatty acids and central nervous system good functioning [7-10; 26-28]. 

This hypothesis states that a combination of an incomplete diet lacking in essential components, and other predispositions, may lead to neuronal malfunctioning, with special highlight to serotoninergic pathways [29-31]. 

They are apparently more affected by the lacking of a specific component (in our particular case noted, the omega 3 fatty acids), disturbing their normal physiology. As these neurons are abundant in the same areas that are seemingly affected in craving, it seems reasonable to argue that they are affected in this condition, and that the replenishment of the missing component may restore these pathways to their normal activity [31,32]. 

Therefore, is important to be taken into account that the omega 3 fatty acids could be an adjuvant treatment for chocolate craving, adjunctively with selective serotonin reuptake inhibitors [33,34]. Perhaps a series of other illnesses that are defined by compulsion (kleptomania and compulsive gambling) as they seem to address craving symptoms directly, with little or no side effects, low costs and good efficacy [35,36]. Even though this study is limited because of its sample size and restriction to the female gender, the results justify greater exploration of the pharmacological potential of PUFA in psychiatric disorders.


Financial disclosures: Pedro Luis Prior, Anna Carolina Ramos, Jaqueline Kalleian Eserian, Ju�ara Xavier Zaparoli and Jos� Carlos Fernandes Galdur�z reported no biomedical financial interests or potential conflicts of interest.






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