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

NCT ID: NCT06610812

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-07-13

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.

Conditions

Polycystic Ovary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

KETOGENIC MEDITERRANEAN diet

Intervention Type: BEHAVIORAL

each patient in group A was instructed briefly about the nature of the treatment regimen to gain the patient's confidence and cooperation. the patient will receive ketogenic Mediterranean diet with aerobic training program. The diet will contain approximately 9300 kJ accordingly, 37% as total fat, 18% as monounsaturated and 9% as saturated, and 33 g of fiber per day 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.

This procedure performed by using the components of ketogenic Mediterranean diet:

• Protein source: fatty fish, seafood, poultry, and eggs.
• Fats and oils: olive oil, avocado oil, and MCT oil (medium-chain triglycerides oil).
• Low carb vegetables: leafy greens, cruciferous vegetables, and other low carb veggies.
• Low carb fruits: avocados, olives, and tomato.
• Flavourings: paprika, cumin, cinnamon, coriander, anise, lemon or lime juice , mint , parsley and garlic .

moderate aerobic exercises

Intervention Type: BEHAVIORAL

moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.

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.

Group Type: EXPERIMENTAL

hypo-caloric diet:

Intervention Type: BEHAVIORAL

Group (b) received low caloric balanced diet regimen with aerobic exercise for 3 months in the form of moderate aerobic exercises in the form of walking for 30 to 45 minutes a day, 3 times per week for 3 months. This group received a diet of 1800 calories or lower accordingly including a combination of two or more of the following in each meal: Non starchy vegetable: spinach, broccoli, cauliflower, peppers, mushrooms, tomatoes, etc.

Fruits: berries, apples bears, citrus fruits, melon, grapes bananas, etc. Starchy vegetables: potatoes peas, sweet potatoes etc. Fish and shellfish: salmon, clams, Trouts, oysters, etc. Eggs: whole eggs are more nutrient dense than white eggs. Poultry and meat: chicken turkey, beef, lamb, etc. Whole grains: oats, brown rice, farro etc. Legumes: chickpeas, kidney beans, lentils etc. Healthy fats: avocados, olive oil, unsweetened coconut, avocado oil. Dairy products: full-fat or reduced fat plain yogurt kefir and full-fat cheese.

moderate aerobic exercises

Intervention Type: BEHAVIORAL

moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.

Interventions

KETOGENIC MEDITERRANEAN diet

each patient in group A was instructed briefly about the nature of the treatment regimen to gain the patient's confidence and cooperation. the patient will receive ketogenic Mediterranean diet with aerobic training program. The diet will contain approximately 9300 kJ accordingly, 37% as total fat, 18% as monounsaturated and 9% as saturated, and 33 g of fiber per day 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.

This procedure performed by using the components of ketogenic Mediterranean diet:

• Protein source: fatty fish, seafood, poultry, and eggs.
• Fats and oils: olive oil, avocado oil, and MCT oil (medium-chain triglycerides oil).
• Low carb vegetables: leafy greens, cruciferous vegetables, and other low carb veggies.
• Low carb fruits: avocados, olives, and tomato.
• Flavourings: paprika, cumin, cinnamon, coriander, anise, lemon or lime juice , mint , parsley and garlic .

Intervention Type: BEHAVIORAL

hypo-caloric diet:

Group (b) received low caloric balanced diet regimen with aerobic exercise for 3 months in the form of moderate aerobic exercises in the form of walking for 30 to 45 minutes a day, 3 times per week for 3 months. This group received a diet of 1800 calories or lower accordingly including a combination of two or more of the following in each meal: Non starchy vegetable: spinach, broccoli, cauliflower, peppers, mushrooms, tomatoes, etc.

Fruits: berries, apples bears, citrus fruits, melon, grapes bananas, etc. Starchy vegetables: potatoes peas, sweet potatoes etc. Fish and shellfish: salmon, clams, Trouts, oysters, etc. Eggs: whole eggs are more nutrient dense than white eggs. Poultry and meat: chicken turkey, beef, lamb, etc. Whole grains: oats, brown rice, farro etc. Legumes: chickpeas, kidney beans, lentils etc. Healthy fats: avocados, olive oil, unsweetened coconut, avocado oil. Dairy products: full-fat or reduced fat plain yogurt kefir and full-fat cheese.

Intervention Type: BEHAVIORAL

moderate aerobic exercises

moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.

Intervention Type: BEHAVIORAL

Other Intervention Names

KETO- MEDITERRANEAN; hypo-caloric balanced diet: aerobic exercises

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

shaimaa Mohamed hamed

Lecturer of physical therapy for women's health in MTIU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo Unversity

Giza, , Egypt

Countries

Egypt

Other Identifiers

Cairo university

Identifier Type: -

Identifier Source: org_study_id