dysmenorrhoe Endometriosis endometriosis
Conditions
Interventions
Subjects will follow an anti-inflammatory diet based on the Dutch Dietary
Guidelines for 13 weeks. They will receive personalized dietary advice from a
dietician and recipes will be available. CBT w
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Diagnosed with endometriosis via ultrasound/MRI/surgery* - Pain NRS score > 4 - Age from 17 years - Premenopausal status - Body Mass Index (BMI) 18-30 kg/m2 - Ability to understand the explanation about the diet intervention (DI) and CBT* - Willing to follow the DI* - Willing to continue their use of food supplements - Willing to undergo CBT* - Willing to collect menstrual effluent * Not apllicable for healthy controls
Exclusion criteria
Exclusion criteria: - Recurrent miscarriages (> 2) - Eating disorder - Diagnosed with Crohn*s disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease - Self-reported celiac disease - Vegan diet - Smoking - Use of immunosuppressive or psychotropic medication - Score on FFQ > 130 - Diagnosed with severe mental disorder currently requiring treatment by psychiatrist - NRS average score below 4 during the last month - Participation in another intervention study - Unable to speak Dutch or to understand the intervention - Need for surgery during the participation in the study - Serious pain (NRS > 4) from other origin than endometriosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the change in HRQoL (as measured by the Endometriosis Health Profile (EHP)-30 and Short Form (SF)-36, as well as a general rating) and pain symptoms (as measured by a Numerical Rating Scale (NRS)). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate the impact of the anti-inflammatory diet on improving the quality of life in patients with endometriosis. 2. Evaluate the impact of CBT on improving the quality of life in patients with endometriosis. 3. Investigate the influence of the anti-inflammatory diet on inflammatory markers in peripheral blood, menstrual effluent, and the vaginal and intestinal microbiome among patients with endometriosis. 4. Investigate the influence of CBT on inflammatory markers in peripheral blood, menstrual effluent, and the vaginal an intestinal microbiome among patients with endometriosis. 5. Assess the changes in Natural Killer (NK) cell populations in menstruum as a result of implementing the anti-inflammatory diet in patients with endometriosis. 6. Assess the changes in Naturel Killer (NL) cell populations in menstruum as a result of implementing CBT in patients with endometriosis. 7. Examine the feasibility of long-term adherence to the anti-inflammatory diet among patients with endometriosis. 8. Determine the effectiveness of CBT in enhancing pain reduction and overall quality of life when combined with the anti-inflammatory diet in patients with endometriosis. 9. To investigate whether pain intensity, pain cognitions, perceived stress, fatigue and objectively measured cortisol levels represent the effects of CBT on QoL in all three groups. 10. To investigate whether CBT serves as a stimulus to promote adherence to the anti-inflammatory diet in patients with endometriosis and whether this reinforces pain-reducing effects. 11. Investigating whether biological data, such as epigenetics and the microbiome, can be used to predict the response to dietary interventions and disease severity. 12. To evaluate the differences in stress (measured by hair cortisol levels), inflammatory markers in peripheral blood, menstrual effluent, and the vaginal and intestinal microbiome between HC and endometriosis patients. | — |
Countries
Netherlands
Contacts
Public ContactJ.S. Hoogstad-van Evert
Radboud Universitair Medisch Centrum
Outcome results
None listed