NCT06882291

Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Intermittent fasting diet	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.
OTHER	Resistive exercise program	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.
DRUG	Medical treatment	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.

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-09-20
• Completion: 2025-09-30
• First posted: 2025-03-18
• Last updated: 2025-03-18

Locations

1 site across 1 country: Egypt