Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05828498 |
| Other study ID # |
OsmaniyeKAUnaad |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Osmaniye Korkut Ata University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study aimed to determine the effect of the Mediterranean diet as medical nutrition
therapy in addition to medical therapy in patients diagnosed with vaginitis.
Description:
In the study, 256 patients were diagnosed with vaginitis in the Obstetrics and Gynecology
clinic. BV was diagnosed in 189 (73.8%) of the patients. Twelve patients with a diagnosis of
BV who did not want to participate were excluded from the study. The Mediterranean diet was
recommended and explained to 113 of the remaining 177 patients. 49 (42.5%) patients were
excluded because the Mediterranean Diet Adherence Scale was <7. 64 (57.5%) patients who were
on a diet and had a Mediterranean Diet Adherence Scale ≥7 were included in the diet group
(group 1) As the control group (group 2), 64 patients participated in the study.
A randomized controlled study was designed to investigate the effect of the Mediterranean
diet on the treatment of vaginitis in patients diagnosed with BV and given medical treatment.
The study was carried out with the collaboration of the Gynecology and Obstetrics Clinic and
Diet Clinic.
Patients diagnosed with BV and given medical treatment were divided into two groups a diet
group and a control group. Patients who were diagnosed with BV, given medical treatment, and
recommended a Mediterranean diet, whose dietary compliance was controlled and compliant with
the Mediterranean diet control questionnaire, who came to the control examination after two
weeks and were accepted to participate in the study, were included in the diet group.
Patients diagnosed with BV, given medical treatment, followed up two weeks later, and
accepted to participate in the study were included in the control group. In the control
examination, the patients were grouped and compared as responsive and resistant after
treatment.
Data collection Demographic data (age, gender), anthropometric measurements, presence of
comorbid disease, menopausal period, presence of diabetes mellitus (DM), medical history, an
average of three-day food consumption, and results of vaginitis treatment in the control
examination of the patients included in the study were recorded. In addition, the patient's
birth history, delivery technique, vaginal operation history, and vaginitis history were
questioned in her medical history.
Anthropometric measurements Body weight (kg), height (cm), total body and abdominal fat ratio
of each patient were measured and recorded by the researcher. Body weights were measured by
the dietitian using a standard weighing instrument sensitive to 100 g without shoes. Values
were determined in kilograms. Height measurements were taken with a Harpenden Stadiometer
without shoes, heels touching, feet open at 45º, arms hanging at attention, head in frankfort
plane. Values were determined in centimeters. BMI was calculated with the formula of body
weight/height squared. Total body and abdominal fat ratio were measured with Tanita.
According to the international BMI classification of the World Health Organization; 30 kg/m²
was classified as obese (17).
Nutrient consumption analysis The patients were asked to write a diary of the foods they
consumed while coming to the control examination. In order for the diary of the foods records
to be reliable, tea glass, water glass, bowl, dessert spoon, tablespoon, serving spoon,
ladle, 1 slice of bread, 1 meatball measure of meat, chicken, fish, 1 slice of cheese and
their quantities were shared visually. Detailed information was given with replica
samples.The foods consumed daily were recorded in the Bebis program. The amount of energy
received by the patients from the average daily food consumption (kcal/day), what percentage
of the daily energy was obtained from carbohydrates (%), and daily protein and fiber
consumption amount (gr) were calculated. The distribution of protein consumption amount as
animals and vegetables was investigated. The frequency of daily consumption of vegetables,
fruits, and grains was recorded.
Mediterranean diet compliance questionnaire The adherence to the Mediterranean diet of the
patients in the diet group who came to the control examination was evaluated with the
'Mediterranean Diet Adherence Scale'. The scale includes the type of oil used by the
participants in meals, daily olive oil consumption, fruit and vegetable portions,
margarine-butter and red meat consumption, weekly wine, pulses, fish-sea products, nuts,
pastry consumption, tomato sauce. olive oil and white meat instead of red meat. It consists
of 14 questions about the choice, to which all points are added by taking 1 point or 0 points
for each question asked according to the consumption amount of the participant (18). Patients
with a Mediterranean Diet Adherence Scale score >7 were considered compliant with the diet
and were included in the study.
Diagnosis and treatment of bacterial vaginitis The obstetrician and gynecologist made the
diagnosis of BV. Vaginal culture and microbiological examination were applied by the
physician when necessary. Oral or vaginal antibiotics (metronidazole, clindamycin) were
administered according to the BV physician's preference.
