KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON Added to Aerobic Exercises POLYCYSTIC OVARIAN ADOLESCENTS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MTI University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- LH/FSH
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to 21 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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:
- •Cardiac problems, epileptics and implanted pacemakers.
- •Malignancy and cardiovascular disease.
- •Women with skin infection.
- •Dysesthesia.
- •Cerebrovascular disease.
- •Uncontrolled diabetes.
- •Severe uncontrolled cardiac patient.
- •Liver and kidney dysfunction.
Arms & Interventions
KETOGENIC MEDITERRANEAN diet
It was consist of 20 adolescent females suffering from polycystic ovary disease. they received ketogenic Mediterranean diet program for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.
Intervention: KETOGENIC MEDITERRANEAN diet (Behavioral)
KETOGENIC MEDITERRANEAN diet
It was consist of 20 adolescent females suffering from polycystic ovary disease. they received ketogenic Mediterranean diet program for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.
Intervention: moderate aerobic exercises (Behavioral)
HYPOCALORIC BALANCED DIET
It was consist of 20 adolescent females suffering from polycystic ovary disease. they received hypo-caloric balanced diet program for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.
Intervention: hypo-caloric diet: (Behavioral)
HYPOCALORIC BALANCED DIET
It was consist of 20 adolescent females suffering from polycystic ovary disease. they received hypo-caloric balanced diet program for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.
Intervention: moderate aerobic exercises (Behavioral)
Outcomes
Primary Outcomes
LH/FSH
Time Frame: 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
Time Frame: 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 Outcomes
- waist-hip ratio(3 months)
Investigators
shaimaa Mohamed hamed
Lecturer of physical therapy for women's health in MTIU
MTI University