Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05175378 |
| Other study ID # |
#E31052019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
March 12, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Iaso Maternity Hospital, Athens, Greece |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Multiple sclerosis (MS) is a chronic immune-mediated neurodegenerative disease that affects
the central nervous system (CNS). The exact pathophysiology of MS remains unclear; it is
suggested that the inflammatory state persists under a genetic-energetic-environmental
complex causing a variety of clinical symptoms depending on the neuroanatomical location of
MS lesions. The age of MS onset ranges between 20 and 40 years. MS is usually initiated as a
relapsing-remitting disease, which may last several years to decades affecting females twice
as often as males. Dietary factors may have an important impact on MS. Data from human and
animal studies indicate that saturated fatty acids (SFA), the major fat type of animal foods
in the "Western" diet, increase MS susceptibility. The Mediterranean dietary (MedDiet)
pattern is hypothesized to be beneficial to MS patients protecting against the development
cardiovascular diseases. However, little is known about the cardiovascular effects of the
MedDiet on MS patients. Consequently, the aim of the present randomized, case control study
was to investigate the effects of MedDiet on cardiovascular factors in women with
relapsing-remitting MS after a 3-month intervention period.
Description:
- Adult women with MS, who were outpatients of Iaso Hospital (Athens, Greece), were
enrolled in the present study. Detailed information was provided using a leaflet, in
which aims and methodology were described before recruitment. All participants fulfilled
informed consent and kept a signed copy. Before the start of the trial, the Ethics
Committee of Iaso Hospital (Athens, Greece) assessed and approved the protocol of the
study (Approval Code #E31052019). The study was performed according to principles of the
Helsinki Declaration (1964) and terms of Good Clinical Practice.
- The study took place during the winter season. All patients were recruited at the first
week of December 2020 and the intervention lasted 3 months.
- Study design: 3-month randomized, single center case control study; maintenance of the
blind-to-treatment allocation was performed in order to avoid bias; in the intervention
group, MS women received a personalized daily eating plan generated by a Clinical
Decision Support System (CDSS) together with nutritional consultation on the
Meditteranean dietary pattern, as well as physical activity guidelines; patients of the
control group received general dietary advice and physical activity recommendation that
was in accordance with the "National Dietary Guidelines for Greek adults";
- Screening: medical history; nutritional history (food frequency questionnaire,
MedDietScore, 24-hr recalls); anthropometrics; depression and anxiety (Hospital Anxiety
and Depression Scale); blood biomarkers (glucose, lipids, C-reactive protein).
