An interventional study of Fish-derived lipid supplementation and Diet based on the Healthy Eating Plate recommendations in Endometriosis and Endometriosis (Diagnosis), sponsored by Angelika Bogusz. Completed at 1 site in Poland. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Angelika Bogusz · Not applicable, Interventional, and Supportive care
Among 29 studies in Endometriosis with a site in Poland — 3 open to participants now, 4 under way, none of them phase 3. Endometriosis · Poland.
Among the 29 studies in Endometriosis with a site in Poland, this one is the 23rd largest by enrollment of the 27 interventional ones, is the only one that started in 2024, is one of 8 with no phase, and was the 29th registered.
920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.
This study's enrollment of 46 is below the median of 67 across 540 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →3 of the 29 studies in Endometriosis with a site in Poland are open now, in 1 country. Each count lists the studies.
Of the 176 Endometriosis studies recruiting now, 51 (29%) set no upper age limit and 123 (70%) stop at 75 or younger; 18 take children under 18; 39 take healthy volunteers.
This study: 18 Years to 55 Years · female · no healthy volunteers.
The full table on the hub →29 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2024.
Median enrollment 187 across the 27 interventional studies, 330 across the 2 observational. Of the 22 that completed or were terminated, 11 (50%) have results posted.
20 of 29 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Angelika Bogusz as lead sponsor.
Angelika Bogusz has 1 study filed under Endometriosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Endometriosis with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07260669Gesynta Pharma ABA Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis | 2027-06 |
Among the 29 studies in Endometriosis with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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.
Time frame: 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.
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 (%)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 12 weeks
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in Jun 2025, 14 months.
Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's 14 months is below that.
Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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