Polycystic Ovary Diseaseketo- MEDITERRNCT06610812
"KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON POLYCYSTIC OVARIAN ADOLESCENTS"
A study testing KETOGENIC MEDITERRANEAN diet, hypo-caloric diet: and moderate aerobic exercises in people with Polycystic Ovary Disease, run by MTI University at 1 site in Egypt.
Trial summary
study was designed to determine the effect of ketogenic Mediterranean diet versus hypocaloric balanced diet on adolescent female with polycystic ovary disease. Read more about this study
- Who is it for?
- Ages 16 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Disease
- What is being tested?
- KETOGENIC MEDITERRANEAN diet, hypo-caloric diet: and moderate aerobic exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 13 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Cerebrovascular disease.
- Uncontrolled diabetes.
- Severe uncontrolled cardiac patient.
- Liver and kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON Added to Aerobic Exercises 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.
Read the 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
- Being tested
- KETOGENIC MEDITERRANEAN diet, hypo-caloric diet:, moderate aerobic exercises
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KETOGENIC MEDITERRANEAN dietBehavioural
Also called KETO- MEDITERRANEAN
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 .
hypo-caloric diet:Behavioural
Also called hypo-caloric balanced 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.
moderate aerobic exercisesBehavioural
Also called aerobic exercises
moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: hypo-caloric diet:; Behavioral: moderate aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 3 months
Secondary outcomes (1)
waist-hip ratio
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Nov 2021
- Primary completion13 Jul 2024
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa Mohamed hamed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610812
- Sponsor's protocol ID
- Cairo university
- Acronym
- keto- MEDITERR
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON Added to Aerobic Exercises POLYCYSTIC OVARIAN ADOLESCENTS
- ClinicalTrials.gov ID
- NCT06610812
- Acronym / sponsor ID
- keto- MEDITERR / Cairo university
- Conditions
- Polycystic Ovary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 13 Jul 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| KETOGENIC MEDITERRANEAN diet | Experimental | Behavioral: KETOGENIC MEDITERRANEAN diet, Behavioral: moderate aerobic exercisesIt 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. |
| HYPOCALORIC BALANCED DIET | Experimental | Behavioral: hypo-caloric diet:, Behavioral: moderate aerobic exercisesIt 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. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- Cardiac problems, epileptics and implanted pacemakers.
- Pregnancy.
- Malignancy and cardiovascular disease.
- Women with skin infection.
- Dysesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KETOGENIC MEDITERRANEAN dietAlso: KETO- MEDITERRANEANeach 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 . | Behavioural | KETOGENIC MEDITERRANEAN diet |
| hypo-caloric diet:Also: hypo-caloric balanced 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. | Behavioural | HYPOCALORIC BALANCED DIET |
| moderate aerobic exercisesAlso: aerobic exercisesmoderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months. | Behavioural | HYPOCALORIC BALANCED DIET, KETOGENIC MEDITERRANEAN diet |
Primary outcome
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)
1 secondary outcome
waist-hip ratio
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KETOGENIC MEDITERRANEAN diet, hypo-caloric diet: and moderate aerobic exercises in people with Polycystic Ovary Disease, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LH/FSH (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.