The effect of diet interventions on quality of life in women with endometriosis related pain symptoms: the Anti-Inflammatory Diet in Endometriosis (AIDEN) study
- Conditions
- dysmenorrhoeEndometroisispainfull menstruation10038612
- Registration Number
- NL-OMON51746
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion criteria for patients are: confirmed endometriosis by ultrasound, MRI
or surgery; inclusion criteria for all participants are: age 18-45 years;
ability to understand the explanation about the dietary intervention,
motivation not to change using food supplements (if applicable), use of
hormonal contraception (combined oral contraception, or progestogens).
Motivation to collect menstrual effluent in stop week
Exclusion criteria are: pregnancy, eating disorders; Crohn*s disease, colitis
ulcerosa, self-reported coeliac disease, self-reported lactose intolerance,
short bowel syndrome, chronic inflammatory disease, veganistic diet,
unwillingness to adhere to the dietary intervention, BMI below 18 or above 30,
smoking, use of immunosuppressive medication, score on FFQ > 120, NRS average
score below 4 during the last month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: The main study parameters are the change in<br /><br>HRQoL (as measured by the Endometriosis Health Profile (EHP)-30 and Short Form<br /><br>(SF)-36, as well as a general rating) and pain symptoms (as measured by a<br /><br>Numerical Rating Scale (NRS)). </p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the effect of an anti-inflammatory diet on characteristics of<br /><br>inflammation in serum and menstruum samples as well as the effect on the gut<br /><br>and vaginal microbiome.</p><br>