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

NCT06610812 | Completed

• 1 other identifier: Cairo university
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Disease

Outcome Measures

Primary Outcomes (2)

• LH/FSH

  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

  3 months

• body mass index

  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)

  3 months

Secondary Outcomes (1)

• waist-hip ratio

  3 months

Study Arms (2)

KETOGENIC MEDITERRANEAN diet

EXPERIMENTAL

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.

Behavioral: KETOGENIC MEDITERRANEAN diet; Behavioral: moderate aerobic exercises

HYPOCALORIC BALANCED DIET

EXPERIMENTAL

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.

Behavioral: hypo-caloric diet:; Behavioral: moderate aerobic exercises

Interventions

KETOGENIC MEDITERRANEAN diet 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 .

Also known as: KETO- MEDITERRANEAN

KETOGENIC MEDITERRANEAN diet

hypo-caloric diet: 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.

Also known as: hypo-caloric balanced diet:

HYPOCALORIC BALANCED DIET

moderate aerobic exercises BEHAVIORAL

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

Also known as: aerobic exercises

HYPOCALORIC BALANCED DIET; KETOGENIC MEDITERRANEAN diet

Eligibility Criteria

• Age: 16 Years - 21 Years
• Gender Eligibility Details: polycystic ovary disease
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• They were conscious and free from any other medical disease.

You may not qualify if:

• Patients were examined by a gynecologist before the study and excluded if they have:
• Cardiac problems, epileptics and implanted pacemakers.
• Pregnancy.
• Malignancy and cardiovascular disease.
• Women with skin infection.
• Dysesthesia.
• Cerebrovascular disease.
• Uncontrolled diabetes.
• Severe uncontrolled cardiac patient.
• Liver and kidney dysfunction.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Cairo Unversity

Giza, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for women's health in MTIU

Model Details: randomized controlled trail

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 24, 2024
• Study Start: November 1, 2021
• Primary Completion: July 13, 2024
• Study Completion: July 13, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

EG (1)