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Clinical Trials/NCT06414226
NCT06414226CompletedNot Applicable

Investigation of the Effect of Krill and Fish Oil Intake on Clinical and Biochemical Findings and Eating Behavior in Adult Individuals With Major Depression Disorders

Firat University2 sites in 2 countries57 target enrollmentStarted: March 21, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
57
Locations
2
Primary Endpoint
Results of Clinical Findings

Study Overview

Brief Summary

The Omega-3 polyunsaturated fatty acids (n-3 PUFA), associated with fish oil, has been one of the most studied non-pharmacological subjects for its effect on Major Depression Disorder (MDD). However, studies comparing the effect of krill oil, on depression are limited, that has similar content and different structural forms with fish oil. This study was conducted to evaluate the effectiveness of the use of krill and fish oil on clinical effects, biochemical outcomes and eating behavior in individuals diagnosed with MDD. It was included 57 adult individuals diagnosed with MDD in the psychiatry clinic in this study. Randomization was performed after inclusion and exclusion criteria were applied in the study, and participants were included in one of three groups. These groups are; 1) krill oil ((n=17), (Eicosapentaenoic acid (EPA)=340 mg, Docosahexaenoic acid (DHA)=180 mg)), 2) fish oil ((n=17)), (EPA=360 mg, DHA=240 mg), 3) placebo ( (n=16), (EPA=0 mg, DHA=0 mg)). The duration of the intervention was 8 weeks. Anthropometric measurements, biochemical outcomes and food consumption records of the participants were taken at the beginning and end of the intervention, and Hamilton depression rating scale (HDRS), depression anxiety stress-21 (DASS-21) and food craving questionnaire (FCQ) was applied to the participants. Statistical Package for Social Sciences (SPSS) and R studio software were used for statistical analysis of the data.

Detailed Description

Introduction

Major Depressive Disorder (MDD) affects approximately 6% of the adult population worldwide each year and is the second greatest contributor to the burden of chronic disease. In the treatment of MDD, both psychotherapy and psychopharmacology are effective. However, approximately 30% of patients do not achieve definitive recovery even after several treatment attempts. Major depressive disorder can affect an individual's life as a whole and is difficult to treat due to its high rate of relapse, and it is often associated with anxiety and cardiovascular diseases (CVD), which can threaten an individual's life. It is estimated that major depression is responsible for 3% of the global burden of disease according to the World Health Organization (WHO) report and that this rate may increase to 7% by 2030. Therefore, alternatives to effective treatments and prevention strategies are urgently needed due to this increasing trend.

Omega-3 polyunsaturated fatty acids (n-3 PUFAs), identified with fish oil, became one of the most researched nutritional topics on the effects of major depressive disorder. Omega-3 polyunsaturated fatty acids are shown to be effective in cardiovascular disease (CVD) prevention due to their anti-inflammatory and cardio-protective effects. It can potentially share common mechanisms with CVD, considering factors such as increased production of pro-inflammatory cytokines, endothelial dysfunction and increases in plasma homocysteine levels, which play a role in the pathophysiology of some psychiatric disorders such as depression. It is possible that omega-3 has multiple positive effects on depression through its neurogenesis and neuroplasticity abilities, as well as having a positive effect on pathophysiological mechanisms. Appleton et al. conducted a Cochrane review to investigate the effect of n-3 PUFA supplements on depression in adults. This review included 25 studies (total 1438 participants) investigating the effect of n-3 PUFA supplements versus placebo and 1 study (40 participants) comparing n-3 PUFA supplements with antidepressant treatment. As a result, it was reported that n-3 PUFA supplements had a modestly positive effect on depression compared to placebo. However, it was emphasized in this report that the majority of the studies (22 studies) had a low level of evidence. This was attributed to factors such as high levels of bias, duration of follow-up, methodological errors and deficiencies due to blinded designs. The general conclusion of the authors was that there was a need for high quality intervention studies in this field.

Although there are a large number of studies focusing on the use of fish oil in depression, research using krill oil, another source rich in n-3 PUFAs, is very limited. Krill oil is an important shellfish that lives in the oceans around the Antarctic continent and attracts attention in research due to its rich omega-3 fatty acid content. As krill is a species living in cold regions, they are rich in EPA and DHA content, along with PUFAs in the form of phospholipids and especially phosphatidylcholine in cell membrane structures. The form containing and binding Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) in krill oil is phospholipids, contrary to triglyceride in fish oil. Therefore, the absorption and bioavailability activities are different because of the difference in the forms in fish and krill oil. Although there are studies on the effects of krill oil on the nervous system on the human research, there is limited research on the effectiveness of krill oil on depression. To our knowledge, there was only one pilot study on rats comparing the treatment efficacy of fish and krill oil on depression. This study compared the antidepressant effects of krill (EPA: 60 mg/500 mg, DHA: 35 mg/500 mg) and fish oil (EPA: 90 mg/500 mg, DHA: 60 mg/500 mg), vitamin B12 and imipramine. As a result, krill oil showed favorable results on a number of variables compared to fish oil, but similar results were found in both groups. It is important to compare the efficacy of krill and fish oil with similar EPA and DHA content on depression to clarify the question of which of these oils in different forms may be more effective on the disease.

Major depressive disorders affect many mechanisms such as food intake, taste perception and food selection. When clinical pictures related to the nutritional status of depressed individuals are examined; changes in appetite, increased consumption of certain food groups and related changes in body weight are frequently observed. In addition, antidepressant drugs used may also affect food intake and weight control. Eating behavior is under the control of complex neural mechanisms, especially serotonin. At the same time, food intake is also effective in the control of serotonin release in serotonergic neurons. Serotonin, which has a bidirectional relationship with eating behavior, is a neurotransmitter involved in the physiopathology of many psychiatric disorders. The presence of a disorder in the serotonin pathway may explain the development of both psychiatric disorders and obesity in the patient. As a result, it was reported that eating behavior disorders, interest in unhealthy food consumption and increased appetite in major depressives, as in some psychiatric disorders, may lead to an increase in body weight in individuals during the illness or in progressive processes. There are several studies examining the relationship between depression and obesity. However, clinical studies to determine the factors leading to this condition are limited. In addition, data collection on eating behavior, appetite and weight status is neglected in most clinical interventions in patients with depression. Therefore, it is important to investigate the efficacy of n-3 fatty acids on appetite and body composition as well as eating behaviors that examine food cravings in depressed individuals.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Between the ages of 19-65 years
  • To be diagnosed with major depression by a psychiatrist in accordance with DSM V diagnostic criteria
  • Not taking antidepressant medication or being on antidepressant medication for the last 1 month without medication change
  • To have signed the informed voluntary consent form.

Exclusion Criteria

  • More than two antidepressants
  • Substance users in the last 6 months
  • Those with alcohol addiction
  • Suicidal ideation and suicidal behaviour (followed up by clinicians)
  • Presence of other psychiatric disorders such as psychosis, schizophrenia and bipolar (except dysthymia and anxiety)
  • Presence of serious chronic diseases
  • Women during pregnancy or lactation
  • People taking medication that may cause emotional symptoms (Escitoloprom/Lexopro etc.)
  • Food allergy
  • Individuals at high risk of bleeding or taking anti-coagulant medication such as warfarin
  • Consuming 3 portions of fish or more per week
  • Use of any nutritional supplements
  • People with hypercholesterolaemia or taking medication for hypercholesterolaemia

Outcomes

Primary Outcomes

Results of Clinical Findings

Time Frame: At baseline, At the end of 4th week and At the end of 8th week

Hamilton Depression Rating Scale (HDRS): The HDRS focuses more on melancholic and physical symptoms of depression. In the HDRS, which consists of twenty-one questions, a score is calculated by answering 17 questions. The items of the scale related to difficulty falling asleep, waking up in the middle of the night, waking up early in the morning, somatic symptoms, genital symptoms, weakening and insight are graded between "0-2" and the other items are graded between "0-4". In the scale; 0-7 points: "no depression", 8-17 points: "mild depression", 18-24 points: "moderate depression" and \>23 points: "severe depression".

Secondary Outcomes

  • Height(At baseline, At the end of 4th week and At the end of 8th week)
  • Dietary Intake(At baseline and At the end of 8th week)
  • Body weight(At baseline, At the end of 4th week and At the end of 8th week)
  • Biochemical Outcomes(At baseline and At the end of 8th week)
  • BMI(At baseline, At the end of 4th week and At the end of 8th week)

Investigators

Sponsor
Firat University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Murat Açık

Associate Professor

Firat University

Study Sites (2)

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