The Mediterranean Diet and Bacterial Vaginitis

NCT ID: NCT05828498

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-03-30

Brief 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.

Detailed 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.

Conditions

Bacterial Vaginitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

grup 1

patients who were on a diet and had a Mediterranean Diet Adherence Scale ≥7 were included in the diet group

THE Mediterranean diet

Intervention Type: DIETARY_SUPPLEMENT

The Mediterranean diet was applied to the patients with bacterial vaginitis selected randomly. diet content and application techniques were explained to the patient.

grup 2

As the control group (group 2), 64 patients participated in the study.

No interventions assigned to this group

Interventions

THE Mediterranean diet

The Mediterranean diet was applied to the patients with bacterial vaginitis selected randomly. diet content and application techniques were explained to the patient.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Patients diagnosed with bacterial vaginitis and given medical treatment were divided into two groups as diet group and control group. Diagnosed with bacterial vaginitis, given medical treatment, not pregnant mediterranean diet recommended The patients whose diet compliance was controlled and complied 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.

Exclusion Criteria

• pregnant under 18 years old out of control Bacterial vaginitis patients who received 7 or less on the Mediterranean diet compliance scale and did not accept to participate in the study were excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Osmaniye Korkut Ata University

OTHER

Sponsor Role: lead

Responsible Party

AYBALA TAZEOGLU

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Osmaniye Korkut ATA University

Osmaniye, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

OsmaniyeKAUnaad

Identifier Type: -

Identifier Source: org_study_id