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Completed

NCT Number: NCT06610812

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Pregnancy.
  • Malignancy and cardiovascular disease.
  • Women with skin infection.
  • Dysesthesia.
  • Cerebrovascular disease.
  • Uncontrolled diabetes.
  • Severe uncontrolled cardiac patient.
  • Liver and kidney dysfunction.

Treatment and study plan

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 .

Other names: KETO- MEDITERRANEAN

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.

Other names: hypo-caloric 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.

Other names: aerobic exercises

Primary outcomes

  1. 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

  2. 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

  1. waist-hip ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON Added to Aerobic Exercises POLYCYSTIC OVARIAN ADOLESCENTS

Acronym: keto- MEDITERR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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