Polycystic Ovary SyndromeNCT06882291
Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S
A study testing Intermittent fasting diet, Resistive exercise program and Medical treatment in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be carried out in an attempt to know which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Intermittent fasting diet, Resistive exercise program and Medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2025to 30 Sep 2025
- 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Seventy two obese women diagnosed with Polycystic ovarian syndrome by the gynecologist (based on the Rotterdam diagnostic criteria)
- Their age will range from 25 to 40 years old.
- Overweight or obese (BMI >25 kg/m2 and < 30 kg/m2).
Who cannot join
- The presence of diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, Severe serious cardiovascular, gastrointestinal, kidney and liver diseases. premature ovarian failure, hypothalamic/pituitary disease
- Hormonal contraceptive use.
- Participants who did not complete the study were excluded from the analysis.
- Use of medication therapy that impacts carbohydrate or lipid metabolism (oral contraceptive pills, insulin sensitizers, anti epileptics, anti psychotics, statins, and fish oil) in the recent 6 months;
- Body weight fluctuations for more than 5% in the past 3 months; in preparation for pregnancy.
- Perimenopausal; night shift workers; fasting for more than 16 h per day; hypotension
- Alcohol intake for more than 100 g per week; smoking within the past 3 months
- Engaging in high intensity exercise.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be carried out in an attempt to know which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.
Read the detailed description
Polycystic ovarian syndrome (PCOS) significantly impacts women, since the broad spectrum of clinical manifestations associated with it are significant and include reproductive dysfunction, menstrual irregularities, and an increased risk of infertility. However, the consequences of PCOS go beyond the reproductive axis, with psychological and social impairments, including stress, depression, anxiety and sexual dissatisfaction. There is also a high prevalence of dyslipidemia, hyperinsulinemia, obesity, hypertension, and glucose intolerance which are risk factors that predispose women to cardiovascular disease (CVD) and diabetes mellitus type 2 (DM2).
Improving Insulin resistance and excess adiposity are therefore key targets in PCOS management. International Evidence Based Guideline for the Assessment and Management of PCOS , highlights lifestyle intervention as the primary early management strategy. Lifestyle interventions are traditionally defined as those designed to improve dietary intake or physical activity through appropriate behavioural support. Time restricted eating (TRF), where patients are asked to consume all energy within a restricted daily time period, appears to offer more sustainable weight loss and cardiometabolic changes and may be more acceptable as a permanent lifestyle change.
Eight hour TRF may have beneficial effects on improving menstruation, hyperandrogenemia and reducing weight especially body fat, decreasing insulin resistance and chronic inflammation in women with anovulatory PCOS. TRF may be suitable for PCOS women with appropriate counseling and patient management.
The progressive resistance training (PRT) improved hyperandrogenism and the menstrual cycle as well as the functional capacity with increased muscle strength and resulted in changes in body composition with increased lean muscle mass and decreased central obesity without a reduced total weight. There were also improvements in quality of life and sexual function as complementary benefits.
So, This study will be carried out in an attempt to know Which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Intermittent fasting diet, Resistive exercise program, Medical treatment
- 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.
Intermittent fasting dietOther
Women in the first experimental group will follow an intermittent fasting diet, where they eat for 8 hours and fast for 16. They can skip breakfast or have an early dinner. Meals will include 500-800 calories of high-fiber and protein-rich foods. Participants can start with 2-3 fasts per week and increase gradually. They must drink 2-3L of water daily and can consume zero-calorie beverages. Weekly assessments will track progress.
Resistive exercise programOther
Women in the second experimental group will receive medical treatment and follow an 8-week resistive exercise program (30 min, 5 days/week). Exercises target the upper body, abdomen, and lower limbs, starting with a 10-min warm-up, followed by 30 min of resistance training (biceps curls, triceps exercises, chest press, plank, crunches, squats, lunges, hamstring, and quadriceps curls), and ending with a 10-min cool-down. Repetitions are logged weekly for assessment.
Medical treatmentDrug
Also called Metformin tablets
Each woman in the three groups will receive medical treatment (metformin tablets) for eight weeks and the dose will prescribed by the gynecologist during the first visit. Patients will be asked to attend the clinic each month for routine monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting diet + medical treatment | Experimental | This group will consist of 24 obese PCOS women who will receive a program of Intermittent fasting diet for eight weeks and a medical treatment. Receives: Other: Intermittent fasting diet; Drug: Medical treatment |
| Resistive exercise program + medical treatment | Experimental | This group will consist of 24 obese PCOS women who will receive a resistive exercise program for 30 minutes 5 times/week for eight weeks and a medical treatment. Receives: Other: Resistive exercise program; Drug: Medical treatment |
| Medical treatment | Active comparator | This group will consist of 24 obese PCOS women who will receive a medical treatment only. Receives: Drug: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOM-IR calculation
It is calculated from fasting glucose and fasting insulin. Different studies provide slightly different ranges for HOM-IR. But they all agree that the higher HOM-IR gets , the more insulin resistance are.
Less than 1 : optimal insulin resistance. Above 1.9 : early insulin resistance. Above 2.9 : significant insulin resistance.
Measured: 8 weeks
Secondary outcomes (6)
Waist circumference measurement
It will be taken around the abdomen at the level of the umbilicus to measure waist circumference correctly. This will be performed before and after treatment for all groups (A,B and C).
Measured: 8 weeks
Waist/ hip ratio assessment
It will be calculated as waist circumference in centimeters divided by hip circumference in centimeters. This will be performed before and after treatment for all groups (A,B and C).
Measured: 8 weeks
Weight measurement
It will be measured before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.
Measured: 8 weeks
Body mass index (BMI) measurement
It will be measured before and after treatment for all groups (A,B and C). The BMI will be calculated by the weight in kilograms divided by square of the height in centimeters according to the formula: BMI = weight (kg)/height2 (m2).
Measured: 8 weeks
Body fat mass (BFM) measurement
It will be measured in kilogram before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.
Measured: 8 weeks
Skeletal muscle mass (SMM) measurement
It will be measured in kilogram before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start20 Mar 2025
- Primary completion20 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Samy Elsayed Elmokadem, Cairo University
- Investigators
- Soheir Mahmoud Elkosery, PhD, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882291
- Sponsor's protocol ID
- P.T.REC/012/005568
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S
- ClinicalTrials.gov ID
- NCT06882291
- Acronym / sponsor ID
- P.T.REC/012/005568
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 18 Mar 2025 (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.
This study will be carried out in an attempt to know which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.
Detailed description
Polycystic ovarian syndrome (PCOS) significantly impacts women, since the broad spectrum of clinical manifestations associated with it are significant and include reproductive dysfunction, menstrual irregularities, and an increased risk of infertility. However, the consequences of PCOS go beyond the reproductive axis, with psychological and social impairments, including stress, depression, anxiety and sexual dissatisfaction. There is also a high prevalence of dyslipidemia, hyperinsulinemia, obesity, hypertension, and glucose intolerance which are risk factors that predispose women to cardiovascular disease (CVD) and diabetes mellitus type 2 (DM2).
Improving Insulin resistance and excess adiposity are therefore key targets in PCOS management. International Evidence Based Guideline for the Assessment and Management of PCOS , highlights lifestyle intervention as the primary early management strategy. Lifestyle interventions are traditionally defined as those designed to improve dietary intake or physical activity through appropriate behavioural support. Time restricted eating (TRF), where patients are asked to consume all energy within a restricted daily time period, appears to offer more sustainable weight loss and cardiometabolic changes and may be more acceptable as a permanent lifestyle change.
Eight hour TRF may have beneficial effects on improving menstruation, hyperandrogenemia and reducing weight especially body fat, decreasing insulin resistance and chronic inflammation in women with anovulatory PCOS. TRF may be suitable for PCOS women with appropriate counseling and patient management.
The progressive resistance training (PRT) improved hyperandrogenism and the menstrual cycle as well as the functional capacity with increased muscle strength and resulted in changes in body composition with increased lean muscle mass and decreased central obesity without a reduced total weight. There were also improvements in quality of life and sexual function as complementary benefits.
So, This study will be carried out in an attempt to know Which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting diet + medical treatment | Experimental | Other: Intermittent fasting diet, Drug: Medical treatmentThis group will consist of 24 obese PCOS women who will receive a program of Intermittent fasting diet for eight weeks and a medical treatment. |
| Resistive exercise program + medical treatment | Experimental | Other: Resistive exercise program, Drug: Medical treatmentThis group will consist of 24 obese PCOS women who will receive a resistive exercise program for 30 minutes 5 times/week for eight weeks and a medical treatment. |
| Medical treatment | Active comparator | Drug: Medical treatmentThis group will consist of 24 obese PCOS women who will receive a medical treatment only. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Seventy two obese women diagnosed with Polycystic ovarian syndrome by the gynecologist (based on the Rotterdam diagnostic criteria)
- Their age will range from 25 to 40 years old.
- Overweight or obese (BMI >25 kg/m2 and < 30 kg/m2).
Key exclusion criteria (8 listed)
- The presence of diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, Severe serious cardiovascular, gastrointestinal, kidney and liver diseases. premature ovarian failure, hypothalamic/pituitary disease
- Hormonal contraceptive use.
- Participants who did not complete the study were excluded from the analysis.
- Use of medication therapy that impacts carbohydrate or lipid metabolism (oral contraceptive pills, insulin sensitizers, anti epileptics, anti psychotics, statins, and fish oil) in the recent 6 months;
- Body weight fluctuations for more than 5% in the past 3 months; in preparation for pregnancy.
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 |
|---|---|---|
| Intermittent fasting dietWomen in the first experimental group will follow an intermittent fasting diet, where they eat for 8 hours and fast for 16. They can skip breakfast or have an early dinner. Meals will include 500-800 calories of high-fiber and protein-rich foods. Participants can start with 2-3 fasts per week and increase gradually. They must drink 2-3L of water daily and can consume zero-calorie beverages. Weekly assessments will track progress. | Other | Intermittent fasting diet + medical treatment |
| Resistive exercise programWomen in the second experimental group will receive medical treatment and follow an 8-week resistive exercise program (30 min, 5 days/week). Exercises target the upper body, abdomen, and lower limbs, starting with a 10-min warm-up, followed by 30 min of resistance training (biceps curls, triceps exercises, chest press, plank, crunches, squats, lunges, hamstring, and quadriceps curls), and ending with a 10-min cool-down. Repetitions are logged weekly for assessment. | Other | Resistive exercise program + medical treatment |
| Medical treatmentAlso: Metformin tabletsEach woman in the three groups will receive medical treatment (metformin tablets) for eight weeks and the dose will prescribed by the gynecologist during the first visit. Patients will be asked to attend the clinic each month for routine monitoring. | Drug | Intermittent fasting diet + medical treatment, Medical treatment, Resistive exercise program + medical treatment |
Primary outcome
HOM-IR calculation
Time frame: 8 weeks
It is calculated from fasting glucose and fasting insulin. Different studies provide slightly different ranges for HOM-IR. But they all agree that the higher HOM-IR gets , the more insulin resistance are. Less than 1 : optimal insulin resistance. Above 1.9 : early insulin resistance. Above 2.9 : significant insulin resistance.
6 secondary outcomes
Waist circumference measurement
Time frame: 8 weeks
Waist/ hip ratio assessment
Time frame: 8 weeks
Weight measurement
Time frame: 8 weeks
Body mass index (BMI) measurement
Time frame: 8 weeks
Body fat mass (BFM) measurement
Time frame: 8 weeks
Skeletal muscle mass (SMM) measurement
Time frame: 8 weeks
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 4 May 2026.
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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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.
Soheir Mahmoud Elkosery, PhD study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting diet, Resistive exercise program and Medical treatment in people with Polycystic Ovary Syndrome, run by Cairo 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 3 inclusion and 8 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 4 May 2026. 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?
HOM-IR calculation (time frame: 8 weeks). 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 4 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.