The primary objective is to investigate the effect of an anti-inflammatory diet on HRQoL and pain symptoms in women with endometriosis. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics…
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: 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 outcome
To investigate the effect of an anti-inflammatory diet on characteristics of
inflammation in serum and menstruum samples as well as the effect on the gut
and vaginal microbiome.
Background summary
Rationale: Inflammation is a key factor in the development, proliferation, and
symptomatology of endometriosis. Several studies have suggested that nutrients
with anti-inflammatory properties may be effective in reducing
endometriosis-associated pain. However, the relation between nutrition,
endometriosis and inflammation is not completely understood. We hypothesise
that an anti-inflammatory diet might improve immune cell function and reduce
inflammation, resulting in improved Health-Related Quality of Life (HRQoL) and
pain scores.
Study objective
The primary objective is to investigate the effect of an anti-inflammatory diet
on HRQoL and pain symptoms in women with endometriosis. The secondary objective
is to investigate the effect of an anti-inflammatory diet on inflammatory
characteristics in serum and menstruum samples as well as the effect on the gut
and vaginal microbiome.
Study design
We propose to perform this feasibility study as preliminary research for a
larger intervention study. This feasibility study will be a 12-week trial with
a pre-post design (T0 to T1) during which 20 women with endometriosis will
adhere to an anti-inflammatory diet. Before this intervention period, subjects
will have a run-in period of 12 weeks (T-1 to T0). To compare within-subject
variability in inflammatory outcomes, five healthy controls will be included in
the run-in period.
Intervention
The anti-inflammatory diet that is advised in this intervention is very similar
to the Dutch Dietary Guidelines 2015 (20). However, the anti-inflammatory diet
is stricter in terms of (red) meat intake, which makes it a predominantly
plant-based diet.
Study burden and risks
For this study, endometriosis patients need to visit the hospital three times
in six months. Healthy controls need to visit the hospital two times in three
months. During these visits, blood samples will be drawn, a vaginal swab will
be taken and the subjects will hand over their samples of menstrual effluent
and faeces. In addition, subjects will be asked to complete several
questionnaires. Furthermore, endometriosis patients will have four consults
with a dietician. Since the investigational treatment consists of dietary
advice based on the Dutch Dietary Guidelines, there are no risks for the
subjects. Endometriosis patients can benefit from participating since HRQoL and
pain symptoms might improve.
Geert Grooteplein 11
Nijmegen 6500 HB
NL
Geert Grooteplein 11
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
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
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | EUdraCT 2022-13492 |
| CCMO | NL80652.091.22 |