"KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON POLYCYSTIC OVARIAN ADOLESCENTS"

Not Applicable

Completed

• Conditions: Polycystic Ovary Disease

• Registration Number: NCT06610812
• Lead Sponsor: MTI University

Brief Summary

study was designed to determine the effect of ketogenic Mediterranean diet versus hypocaloric balanced diet on adolescent female with polycystic ovary disease.

Detailed Description

this study wsa designed to investigate the effect of the ketogenic Mediterranean diet in comparison with hypo-caloric diet on obese adolescent female's patients with polycystic ovary disease trying to find out a new physical therapy approach that had positive effect in the treatment and care for such cases which could enhance the physical therapy field.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2024-07-13
• Study Completion: 2024-07-13
• Status Verified: 2024-09
• Study First Submitted: 2024-09-21
• Study First Submitted QC: 2024-09-21
• Last Update Submitted: 2024-09-21
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1 - All patients were adolescent females. 2- All patients ages ranged from 16 to 21years old. 3- Their BMI ranged from 25kg/m² to 35kg/m². 4- All patients were suffering from hormonal disturbances confirmed by their lab tests and cysts in the ovaries that confirm their diagnosis with polycystic ovary disease.

5- They were conscious and free from any other medical disease.

Exclusion Criteria

Patients were examined by a gynecologist before the study and excluded if they have:

1. Cardiac problems, epileptics and implanted pacemakers.
2. Pregnancy.
3. Malignancy and cardiovascular disease.
4. Women with skin infection.
5. Dysesthesia.
6. Cerebrovascular disease.
7. Uncontrolled diabetes.
8. Severe uncontrolled cardiac patient.
9. Liver and kidney dysfunction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LH/FSH	3 months	Blood sample was taken from each woman before starting the study to measure the level of androgen in the blood and LH/FSH which will be estimated again after 3months to its level after each type of diet
body mass index	3 months	Weight and height measured while the patient is wearing a thin layer of clothes to calculate the body mass index according to the following equation in both groups: BMI=weight/height2 (Kg/m2)

Secondary Outcome Measures

Name	Time	Method
waist-hip ratio	3 months	A tape measurement wase used to determine the hip and waist circumference of each patient to calculate the waist-hip ratio by dividing the waist reading over the hip reading (the waist circumference should be measured at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest , hip circumference obtained by measuring at the top of the iliac crest in case the waist is convex rather than concave, such as with different body types, and obesity, the waist may be measured at a horizontal level (2.5 cm) above the umbilicus .for both measurements.

Trial Locations

Locations (1)

Cairo Unversity; 🇪🇬 Giza, Egypt