Comparison of Krill and Fish Oil on Clinical and Biochemical Outcomes in Depression

NCT06414226 | Completed

• 1 other identifier: 2021/05-35
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

depression; anxiety; fish oil; krill oil; eating behavior

Outcome Measures

Primary Outcomes (2)

• Results of Clinical Findings

  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".

  At baseline, At the end of 4th week and At the end of 8th week

• Results of Clinical Findings

  Depression Anxiety Stress Scale-21 (DASS-21): Depression Anxiety Stress Scale-21 consists of a total of 21 items aiming to measure depression, anxiety and stress levels. An individual's score of 5 points or more from the depression sub-dimension, 4 points or more from anxiety, and 8 points or more from stress indicates that he/she has the related problem.

  At baseline, At the end of 4th week and At the end of 8th week

Secondary Outcomes (5)

• Biochemical Outcomes

  At baseline and At the end of 8th week

• 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

• BMI

  At baseline, At the end of 4th week and At the end of 8th week

Other Outcomes (1)

• Evaluation of Eating Behaviour of the Study

  At baseline and At the end of 8th week

Study Arms (3)

Krill group

EXPERIMENTAL

Krill oil ((n=17), (EPA=340 mg, DHA=180 mg)), The duration of the intervention was 8 weeks.

Dietary Supplement: Krill and Fish Oil vs. Placebo

Fish group

EXPERIMENTAL

2\) fish oil ((n=17)), (EPA=360 mg, DHA=240 mg), The duration of the intervention was 8 weeks.

Dietary Supplement: Krill and Fish Oil vs. Placebo

Placebo

PLACEBO COMPARATOR

Placebo capsule ( (n=16), (EPA=0 mg, DHA=0 mg)). The duration of the intervention was 8 weeks.

Dietary Supplement: Krill and Fish Oil vs. Placebo

Interventions

Krill and Fish Oil vs. Placebo DIETARY_SUPPLEMENT

Participants were prescribed to take a daily dose of 4 capsules (4×500 mg= 2 g/day) stored at an appropriate temperature during the 8-week treatment period. The patients were informed to take 2 of the capsules in the bottle to be taken orally daily in the morning before breakfast and the other 2 capsules before dinner. The capsule bottles contained 500 mg concentrated krill oil, fish oil or placebo (empty capsule) capsules. The daily intake of EPA+DHA from krill and fish oil was determined as 520 mg and 600 mg, respectively. Krill and fish oil were obtained from Aniqnaturals Superba and Orzax Ocean company, respectively.

Also known as: Aniqnaturals Superba Krill Oil, Ocean Fish Oil

Fish group; Krill group; Placebo

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead
• Adiyaman University Research Hospital: collaborator

Study Sites (1)

Adıyaman University Training and Research Hospital

Adıyaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Behavior, Animal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomised Controlled Double-Blinded

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: May 16, 2024
• Study Start: March 21, 2022
• Primary Completion: July 4, 2022
• Study Completion: October 24, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)