Effect of Fish-Derived Lipids in Women With Endometriosis

NCT07800442 | Completed

• 1 other identifier: 5/RKE/2024/U
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a chronic inflammatory gynecological disease that may be associated with pelvic pain, painful menstruation, reduced quality of life, impaired daily functioning, and changes in nutritional and metabolic health. Diet, particularly the type and amount of dietary fatty acids, may influence inflammatory pathways involved in endometriosis. The purpose of this interventional study is to evaluate the effect of a 12-week nutritional intervention using BioMarine® Medical Immuno \& Neuro Lipids, a food for special medical purposes containing fish-derived lipids, on nutritional status, inflammatory status, lipid profile, pain perception, health status, and health-related quality of life in women with endometriosis. The study includes 50 women aged 18 to 40 years with endometriosis confirmed by a gynecologist. Participants are randomly assigned to one of two groups. The control group follows a balanced diet based on the Polish Healthy Eating Plate recommendations. The intervention group follows the same dietary recommendations and additionally consumes BioMarine® Medical Immuno \& Neuro Lipids at a dose of 0.5 ml/kg body weight daily for 12 weeks. The study assesses dietary habits, nutritional knowledge, dietary intake, anthropometric measurements, body composition, lipid profile, selected inflammatory markers, calprotectin, pain intensity, and endometriosis-related quality of life. The results may help to better understand whether fish-derived lipids combined with dietary intervention can support symptom management and improve selected health outcomes in women with endometriosis.

Conditions

Endometriosis; Endometriosis (Diagnosis)

Keywords

endometriosis; dietary intervention; omega-3 fatty acids; fish-derived lipids

Outcome Measures

Primary Outcomes (2)

• Change in serum inflammatory cytokine concentrations

  Change in serum inflammatory cytokine concentrations will be assessed by measuring interleukin-1 beta, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor alpha concentrations in blood samples. The outcome will be analyzed as the change in cytokine concentrations from baseline to the end of the 12-week dietary intervention.

  Baseline and 12 weeks

• Change in fecal calprotectin concentration

  Change in fecal calprotectin concentration will be assessed using stool samples. Fecal calprotectin concentration will be analyzed as the change from baseline to the end of the 12-week dietary intervention.

  Baseline and 12 weeks

Secondary Outcomes (26)

• Change in lipid profile parameters

  Baseline and 12 weeks

• Change in endometriosis-associated pain intensity assessed with the Visual Analogue Scale

  Baseline and 12 weeks

• Change from baseline in Endometriosis Health Profile-30 (EHP-30) Pain domain score

  Baseline and 12 weeks

• Change from baseline in Endometriosis Health Profile-30 (EHP-30) Control and Powerlessness domain score

  Baseline and 12 weeks

• Change from baseline in Endometriosis Health Profile-30 (EHP-30) Emotional Well-being domain score

  Baseline and 12 weeks

Study Arms (2)

Diet based on the Healthy Eating Plate recommendations

ACTIVE COMPARATOR

Participants in this group follow a balanced diet based on the Healthy Eating Plate recommendations for 12 weeks.

Behavioral: Diet based on the Healthy Eating Plate recommendations

Dietary Intervention Plus Fish-derived lipids

EXPERIMENTAL

Participants in this group follow a balanced diet based on the Healthy Eating Plate recommendations and additionally consume BioMarine® Medical Immuno \& Neuro Lipids at a dose of 0.5 ml/kg body weight per day for 12 weeks.

Dietary Supplement: Fish-derived lipid supplementation

Interventions

Fish-derived lipid supplementation DIETARY_SUPPLEMENT

Participants in the group consume BioMarine® Medical Immuno \& Neuro Lipids, a food for special medical purposes containing fish-derived lipids, in addition to dietary recommendations based on the Healthy Eating Plate. The product is consumed at a dose of 0.5 ml/kg body weight per day for 12 weeks, divided into two portions taken 15 to 20 minutes before breakfast and dinner. If adverse reactions occur, the daily dose may be divided into three portions taken before breakfast, lunch, and dinner.

Also known as: BioMarine® Medical Immuno & Neuro Lipids

Dietary Intervention Plus Fish-derived lipids

Diet based on the Healthy Eating Plate recommendations BEHAVIORAL

Participants receive individualized dietary recommendations based on the Healthy Eating Plate model. The diet emphasizes regular, balanced meals composed mainly of vegetables and fruits, whole-grain cereal products, sources of high-quality protein, and healthy fats. Participants are advised to limit highly processed foods, added sugars, excessive salt, and saturated fatty acids. The intervention focuses on improving overall diet quality, supporting adequate nutrient intake, and promoting dietary habits consistent with general healthy eating recommendations. The dietary intervention lasts 12 weeks.

Also known as: Healthy Eating Plate-based diet

Diet based on the Healthy Eating Plate recommendations

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female sex.
• Age \>18 years and \<55 years.
• Diagnosis of endometriosis confirmed by a gynecologist.
• Ability and willingness to provide written informed consent.
• Ability and willingness to comply with the study procedures, including dietary recommendation

You may not qualify if:

• Pregnancy or lactation.
• Menopause or postmenopausal status.
• Liver, kidney, or heart disease.
• Acute inflammatory conditions, including acute inflammation of the intestines, pancreas, liver, or gallbladder.
• Fish allergy or hypersensitivity to any component of the study product.
• Epilepsy.
• Implanted medical devices or materials, including pacemaker, defibrillator, stent, metal suture in the heart or blood vessel, or implants.
• Previous radiotherapy or chemotherapy.
• Health condition requiring a specialist diet.
• Current use of dietary supplements containing n-3, n-6, or n-9 fatty acids.

Sponsors & Collaborators

• Angelika Bogusz: lead
• Marinex International Sp. z o.o.: collaborator

Study Sites (1)

Warsaw University of Life Sciences

Warsaw, Poland

Location

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angelika Bogusz, MsC

  warsaw univeristy of life science

  PRINCIPAL INVESTIGATOR

• Magdalena Górnicka, Assoc. Prof.

  Warsaw University of Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No masking is used. Participants and study personnel are aware of the assigned intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to one of two parallel groups. The control group follows a balanced diet based on the Healthy Eating Plate recommendations. The intervention group follows the same dietary recommendations and additionally consumes BioMarine® Medical Immuno \& Neuro Lipids at a dose of 0.5 ml/kg body weight per day for 12 weeks.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: September 2, 2026
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)