Effect of Fish-Derived Lipids in Women With Endometriosis

NCT07800442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-09-02

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Fish-derived lipid supplementation

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.

BEHAVIORAL

Diet based on the Healthy Eating Plate recommendations

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.

Sponsors & Collaborators

  • Marinex International Sp. z o.o.

    collaborator INDUSTRY
  • Angelika Bogusz

    lead OTHER

Principal Investigators

  • Angelika Bogusz, MsC · warsaw univeristy of life science

  • Magdalena Górnicka, Assoc. Prof. · Warsaw University of Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-06-01
Completion
2026-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800442 on ClinicalTrials.gov