Endometriosisfish-endoNCT07800442
Effect of Fish-Derived Lipids in Women With Endometriosis
A study testing Fish-derived lipid supplementation and Diet based on the Healthy Eating Plate recommendations in people with Endometriosis and Endometriosis (Diagnosis), run by Angelika Bogusz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis, Endometriosis (Diagnosis)
- What is being tested?
- Fish-derived lipid supplementation and Diet based on the Healthy Eating Plate recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fish-Derived Lipids on Inflammatory Status, Nutritional Status, Pain Perception, Health-Related Quality of Life, and Health Outcomes in Women With Endometriosis
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.
Read more
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.
Read the detailed description
This is an interventional study conducted among women diagnosed with endometriosis. Endometriosis is a chronic, estrogen-dependent inflammatory disease associated with pelvic pain, painful and heavy menstruation, reduced fertility, impaired daily functioning, and reduced health-related quality of life. Inflammation plays an important role in the pathophysiology of endometriosis and may involve prostaglandins, interleukins, tumor necrosis factor alpha, vascular endothelial growth factor, and other inflammatory mediators.
Dietary factors, particularly the quality and type of dietary fatty acids, may influence inflammatory pathways. Saturated fatty acids and trans fatty acids may promote inflammatory processes, whereas mono- and polyunsaturated fatty acids, especially omega-3 fatty acids such as eicosapentaenoic acid and docosahexaenoic acid, may contribute to the regulation of inflammatory responses. However, evidence regarding the effect of complex fish-derived lipid preparations on inflammatory status, lipid metabolism, intestinal inflammation, pain, nutritional status, and quality of life in women with endometriosis remains limited.
The purpose of this study is to evaluate the effect of a 12-week nutritional intervention using BioMarine® Medical Immuno \& Neuro Lipids, a food for special medical purposes, on nutritional status, inflammatory status, lipid profile, pain perception, health status, and health-related quality of life in women with endometriosis.
The study includes 46 women aged 18 to 40 years with endometriosis confirmed by a gynecologist. Participants are randomly assigned to one of two parallel 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 daily for 12 weeks. The product is consumed at a dose of 0.5 ml/kg body weight per day, 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.
The dietary intervention aims to improve overall diet quality and support a balanced dietary pattern. Participants are asked to maintain their usual physical activity patterns during the study. Health status and well-being are monitored through online meetings and telephone contact to identify possible adverse events. Participants also keep an intervention diary in which they record consumed foods and beverages, prescribed and non-prescribed medications, painkillers, contraceptives, supplements, topical preparations, and herbal products.
Assessments are performed before the intervention, after 6 weeks, and after 12 weeks, depending on the type of measurement. Dietary intake and eating habits are assessed using selected questions from the KomPAN questionnaire and 3-day dietary records. Nutritional knowledge and dietary habits are also evaluated using an online questionnaire.
Nutritional status is assessed using anthropometric measurements and body composition analysis. Measurements include body weight, height, waist circumference, hip circumference, body mass index, waist-to-hip ratio, and waist-to-height ratio. Body composition is assessed using bioelectrical impedance analysis and dual-energy X-ray absorptiometry.
Biochemical assessment is performed using fasting venous blood samples collected before and after the intervention. The analyzed parameters include serum lipid profile, including total cholesterol, HDL cholesterol, LDL cholesterol, non-HDL cholesterol, and triglycerides. Selected inflammatory markers are also assessed, including interleukin-1, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor alpha, and fecal calprotectin.
Pain intensity is assessed using the Visual Analogue Scale. Health-related quality of life is assessed using the Endometriosis Health Profile Questionnaire. The study also evaluates dietary knowledge and eating habits in order to identify areas where women with endometriosis may benefit from nutritional education.
The main aim of the study is to determine whether the addition of BioMarine® Medical Immuno \& Neuro Lipids to a balanced dietary intervention provides additional benefits compared with dietary intervention alone in women with endometriosis. The study may provide new knowledge on the relationship between nutrition, fish-derived lipids, inflammatory status, lipid metabolism, intestinal inflammation, pain perception, nutritional status, and quality of life in this population.
- Conditions
- Endometriosis, Endometriosis (Diagnosis)
- Being tested
- Fish-derived lipid supplementation, Diet based on the Healthy Eating Plate recommendations
- Keywords
- endometriosis, dietary intervention, omega-3 fatty acids, fish-derived lipids
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish-derived lipid supplementationDietary supplement
Also called BioMarine® Medical Immuno & Neuro Lipids
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.
Diet based on the Healthy Eating Plate recommendationsBehavioural
Also called Healthy Eating Plate-based diet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Fish-derived lipid supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (26)
Change in lipid profile parameters
Change in lipid profile parameters will be assessed based on fasting blood samples, including total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglyceride concentrations. Outcomes will be analyzed as changes from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change in endometriosis-associated pain intensity assessed with the Visual Analogue Scale
Endometriosis-associated pain intensity is assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. The outcome is defined as the change in VAS score from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Pain domain score
Endometriosis-related quality of life in the Pain domain is assessed using the Endometriosis Health Profile-30 (EHP-30). The Pain domain score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. The outcome is defined as the change in the Pain domain score from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Control and Powerlessness domain score
Endometriosis-related quality of life in the Control and Powerlessness domain is assessed using the Endometriosis Health Profile-30 (EHP-30). The Control and Powerlessness domain score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. The outcome is defined as the change in the Control and Powerlessness domain score from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Emotional Well-being domain score
Endometriosis-related quality of life in the Emotional Well-being domain is assessed using the Endometriosis Health Profile-30 (EHP-30). The Emotional Well-being domain score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. The outcome is defined as the change in the Emotional Well-being domain score from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Self-image domain score
Endometriosis-related quality of life in the Self-image domain is assessed using the Endometriosis Health Profile-30 (EHP-30). The Self-image domain score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. The outcome is defined as the change in the Self-image domain score from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Social Support domain score
Endometriosis-related quality of life in the Social Support domain is assessed using the Endometriosis Health Profile-30 (EHP-30). The Social Support domain score ranges from 0 to 100, with higher scores indicating worse health-related quality of life. The outcome is defined as the change in the Social Support domain score from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in body weight
Body weight is measured in kilograms. The outcome is defined as the change in body weight from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in hip circumference
Hip circumference is measured in centimeters. The outcome is defined as the change in hip circumference from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in waist circumference
Waist circumference is measured in centimeters. The outcome is defined as the change in waist circumference from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in waist-to-hip ratio (WHR)
Waist-to-hip ratio (WHR) is calculated as waist circumference divided by hip circumference. The outcome is defined as the change from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in waist-to-height ratio (WHtR)
Waist-to-height ratio (WHtR) is calculated as waist circumference divided by height. The outcome is defined as the change from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in body mass index (BMI)
Body mass index (BMI) is calculated as body weight in kilograms divided by height in meters squared (kg/m²). The outcome is defined as the change from baseline to the end of the 12-week dietary intervention.
Measured: Baseline and 12 weeks
Change from baseline in body fat percentage assessed using bioelectrical impedance analysis
Body fat percentage is assessed using bioelectrical impedance analysis (BIA) and expressed as the percentage of total body mass consisting of fat mass. The outcome is defined as the change in body fat percentage from baseline to the end of the 12-week dietary intervention. Unit: Percent (%)
Measured: Baseline and 12 weeks
Change from baseline in average daily energy intake
Average daily energy intake is assessed using 3-day weighed food records and expressed in kilocalories per day (kcal/day). The outcome is defined as the change in average daily energy intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in protein intake
Average daily energy intake is assessed using 3-day weighed food records and expressed in kilocalories per day (kcal/day). The outcome is defined as the change in average daily energy intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in carbohydrate intake
Carbohydrate intake is assessed using 3-day weighed food records and expressed as a percentage of total energy intake. The outcome is defined as the change in carbohydrate intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in total fat intake
Total fat intake is assessed using 3-day weighed food records and expressed as a percentage of total energy intake. The outcome is defined as the change in total fat intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in saturated fatty acid intake
Saturated fatty acid (SFA) intake is assessed using 3-day weighed food records and expressed in grams per day. The outcome is defined as the change in SFA intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in monounsaturated fatty acid intake
Monounsaturated fatty acid (MUFA) intake is assessed using 3-day weighed food records and expressed in grams per day. The outcome is defined as the change in MUFA intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in polyunsaturated fatty acid intake
Polyunsaturated fatty acid (PUFA) intake is assessed using 3-day weighed food records and expressed in grams per day. The outcome is defined as the change in PUFA intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in total omega-6 fatty acid intake
Total omega-6 (n-6) fatty acid intake is assessed using 3-day weighed food records and expressed in grams per day. The outcome is defined as the change in total omega-6 fatty acid intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in total omega-3 fatty acid intake
Total omega-3 (n-3) fatty acid intake is assessed using 3-day weighed food records and expressed in grams per day. The outcome is defined as the change in total omega-3 fatty acid intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in eicosapentaenoic acid plus docosahexaenoic acid intake
Combined eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) intake is assessed using 3-day weighed food records and expressed in grams per day. The outcome is defined as the change in combined EPA and DHA intake from baseline to the end of the 12-week dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in Pro-Healthy Diet Index-10 (pHDI-10) score assessed using the KomPAN questionnaire
Diet quality is assessed using the Pro-Healthy Diet Index-10 (pHDI-10) derived from the KomPAN Dietary Habits and Nutrition Beliefs Questionnaire. The pHDI-10 score ranges from 0 to 100 points, with higher scores indicating a higher frequency of consumption of foods considered pro-healthy. The outcome is defined as the change in pHDI-10 score from baseline to the end of the dietary intervention.
Measured: baseline, 12 weeks
Change from baseline in nutrition knowledge score assessed using the KomPAN questionnaire
Nutrition knowledge is assessed using the nutrition knowledge section of the KomPAN Dietary Habits and Nutrition Beliefs Questionnaire. The score is based on 25 statements concerning food and nutrition. One point is assigned for each correct response and zero points for an incorrect or "unsure" response. The total score ranges from 0 to 25 points, with higher scores indicating greater nutrition knowledge. The outcome is defined as the change in nutrition knowledge score from baseline to the end of the dietary intervention.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Apr 2024
- Primary completion1 Jun 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelika Bogusz
- Sponsor type
- University, hospital or other
- Collaborators
- Marinex International Sp. z o.o.
- Responsible party
- Sponsor-investigator, Angelika Bogusz, Warsaw University of Life Sciences
- Investigators
- Angelika Bogusz, MsC, Principal investigator, warsaw univeristy of life scienceMagdalena Górnicka, Assoc. Prof., Study director, Warsaw University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800442
- Sponsor's protocol ID
- 5/RKE/2024/U
- Acronym
- fish-endo
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to ethical and privacy restrictions related to sensitive health data. Aggregated and anonymized results may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish-Derived Lipids on Inflammatory Status, Nutritional Status, Pain Perception, Health-Related Quality of Life, and Health Outcomes in Women With Endometriosis
- ClinicalTrials.gov ID
- NCT07800442
- Acronym / sponsor ID
- fish-endo / 5/RKE/2024/U
- Conditions
- Endometriosis, Endometriosis (Diagnosis)
- Keywords
- endometriosis, dietary intervention, omega-3 fatty acids, fish-derived lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Angelika BoguszUniversity, hospital or other
- Collaborators
- Marinex International Sp. z o.o.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an interventional study conducted among women diagnosed with endometriosis. Endometriosis is a chronic, estrogen-dependent inflammatory disease associated with pelvic pain, painful and heavy menstruation, reduced fertility, impaired daily functioning, and reduced health-related quality of life. Inflammation plays an important role in the pathophysiology of endometriosis and may involve prostaglandins, interleukins, tumor necrosis factor alpha, vascular endothelial growth factor, and other inflammatory mediators.
Dietary factors, particularly the quality and type of dietary fatty acids, may influence inflammatory pathways. Saturated fatty acids and trans fatty acids may promote inflammatory processes, whereas mono- and polyunsaturated fatty acids, especially omega-3 fatty acids such as eicosapentaenoic acid and docosahexaenoic acid, may contribute to the regulation of inflammatory responses. However, evidence regarding the effect of complex fish-derived lipid preparations on inflammatory status, lipid metabolism, intestinal inflammation, pain, nutritional status, and quality of life in women with endometriosis remains limited.
The purpose of this study is to evaluate the effect of a 12-week nutritional intervention using BioMarine® Medical Immuno \& Neuro Lipids, a food for special medical purposes, on nutritional status, inflammatory status, lipid profile, pain perception, health status, and health-related quality of life in women with endometriosis.
The study includes 46 women aged 18 to 40 years with endometriosis confirmed by a gynecologist. Participants are randomly assigned to one of two parallel 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 daily for 12 weeks. The product is consumed at a dose of 0.5 ml/kg body weight per day, 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.
The dietary intervention aims to improve overall diet quality and support a balanced dietary pattern. Participants are asked to maintain their usual physical activity patterns during the study. Health status and well-being are monitored through online meetings and telephone contact to identify possible adverse events. Participants also keep an intervention diary in which they record consumed foods and beverages, prescribed and non-prescribed medications, painkillers, contraceptives, supplements, topical preparations, and herbal products.
Assessments are performed before the intervention, after 6 weeks, and after 12 weeks, depending on the type of measurement. Dietary intake and eating habits are assessed using selected questions from the KomPAN questionnaire and 3-day dietary records. Nutritional knowledge and dietary habits are also evaluated using an online questionnaire.
Nutritional status is assessed using anthropometric measurements and body composition analysis. Measurements include body weight, height, waist circumference, hip circumference, body mass index, waist-to-hip ratio, and waist-to-height ratio. Body composition is assessed using bioelectrical impedance analysis and dual-energy X-ray absorptiometry.
Biochemical assessment is performed using fasting venous blood samples collected before and after the intervention. The analyzed parameters include serum lipid profile, including total cholesterol, HDL cholesterol, LDL cholesterol, non-HDL cholesterol, and triglycerides. Selected inflammatory markers are also assessed, including interleukin-1, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor alpha, and fecal calprotectin.
Pain intensity is assessed using the Visual Analogue Scale. Health-related quality of life is assessed using the Endometriosis Health Profile Questionnaire. The study also evaluates dietary knowledge and eating habits in order to identify areas where women with endometriosis may benefit from nutritional education.
The main aim of the study is to determine whether the addition of BioMarine® Medical Immuno \& Neuro Lipids to a balanced dietary intervention provides additional benefits compared with dietary intervention alone in women with endometriosis. The study may provide new knowledge on the relationship between nutrition, fish-derived lipids, inflammatory status, lipid metabolism, intestinal inflammation, pain perception, nutritional status, and quality of life in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diet based on the Healthy Eating Plate recommendations | Active comparator | Behavioral: Diet based on the Healthy Eating Plate recommendationsParticipants in this group follow a balanced diet based on the Healthy Eating Plate recommendations for 12 weeks. |
| Dietary Intervention Plus Fish-derived lipids | Experimental | Dietary Supplement: Fish-derived lipid supplementationParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish-derived lipid supplementationAlso: BioMarine® Medical Immuno & Neuro LipidsParticipants 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. | Dietary supplement | Dietary Intervention Plus Fish-derived lipids |
| Diet based on the Healthy Eating Plate recommendationsAlso: Healthy Eating Plate-based dietParticipants 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. | Behavioural | Diet based on the Healthy Eating Plate recommendations |
Primary outcome
Change in serum inflammatory cytokine concentrations
Time frame: Baseline and 12 weeks
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.
Change in fecal calprotectin concentration
Time frame: Baseline and 12 weeks
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.
26 secondary outcomes
Change in lipid profile parameters
Time frame: Baseline and 12 weeks
Change in endometriosis-associated pain intensity assessed with the Visual Analogue Scale
Time frame: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Pain domain score
Time frame: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Control and Powerlessness domain score
Time frame: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Emotional Well-being domain score
Time frame: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Self-image domain score
Time frame: Baseline and 12 weeks
Change from baseline in Endometriosis Health Profile-30 (EHP-30) Social Support domain score
Time frame: Baseline and 12 weeks
Change from baseline in body weight
Time frame: Baseline and 12 weeks
Change from baseline in hip circumference
Time frame: Baseline and 12 weeks
Change from baseline in waist circumference
Time frame: Baseline and 12 weeks
Change from baseline in waist-to-hip ratio (WHR)
Time frame: Baseline and 12 weeks
Change from baseline in waist-to-height ratio (WHtR)
Time frame: Baseline and 12 weeks
Change from baseline in body mass index (BMI)
Time frame: Baseline and 12 weeks
Change from baseline in body fat percentage assessed using bioelectrical impedance analysis
Time frame: Baseline and 12 weeks
Change from baseline in average daily energy intake
Time frame: baseline, 12 weeks
Change from baseline in protein intake
Time frame: baseline, 12 weeks
Change from baseline in carbohydrate intake
Time frame: baseline, 12 weeks
Change from baseline in total fat intake
Time frame: baseline, 12 weeks
Change from baseline in saturated fatty acid intake
Time frame: baseline, 12 weeks
Change from baseline in monounsaturated fatty acid intake
Time frame: baseline, 12 weeks
Change from baseline in polyunsaturated fatty acid intake
Time frame: baseline, 12 weeks
Change from baseline in total omega-6 fatty acid intake
Time frame: baseline, 12 weeks
Change from baseline in total omega-3 fatty acid intake
Time frame: baseline, 12 weeks
Change from baseline in eicosapentaenoic acid plus docosahexaenoic acid intake
Time frame: baseline, 12 weeks
Change from baseline in Pro-Healthy Diet Index-10 (pHDI-10) score assessed using the KomPAN questionnaire
Time frame: baseline, 12 weeks
Change from baseline in nutrition knowledge score assessed using the KomPAN questionnaire
Time frame: baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to ethical and privacy restrictions related to sensitive health data. Aggregated and anonymized results may be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelika Bogusz, MsC principal investigator
warsaw univeristy of life science
Magdalena Górnicka, Assoc. Prof. study director
Warsaw University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish-derived lipid supplementation and Diet based on the Healthy Eating Plate recommendations in people with Endometriosis and Endometriosis (Diagnosis), run by Angelika Bogusz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum inflammatory cytokine concentrations (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.