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NCT Number: NCT07683286

Pilates Exercises Versus Intermittent Fasting Diet on Physical and Metabolic Aging Process in Obese Perimenopausal Women

This study aims to compare the effect of pilates exercises versus intermittent fasting diet on physical and metabolic aging parameters in obese perimenopausal women.

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Key information

Age range

40 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadeel Adil Mohamed

Al Fayyum, Egypt

About this study

Obesity is associated with a shorter life expectancy, partly due to its role in accelerating the aging process. The conditions and comorbidities linked to obesity mirror those of age-related diseases. Individuals with obesity are at a higher risk for various age-related conditions, including cardiovascular disease (CVD), hypertension, type 2 diabetes mellitus (T2DM), and cance.

Aging is a natural part of the human life cycle, characterized by a gradual loss of physiological integrity, leading to functional decline and increased vulnerability to mortality. Alongside the onset of age-related diseases in older adults, common aging phenotypes, such as redox imbalance, mitochondrial dysfunction, increased apoptosis, cellular senescence, insufficient autophagy, and chronic inflammation, are observed in both humans and animals. Similar mechanisms underpin the onset of age-related diseases in obesity and excessive calorie intake, suggesting that obesity accelerates aging through these interconnected pathways.

Pilates has gained popularity as a holistic exercise approach that emphasizes respiration, body control, and movement precision. Current research supports the positive effects of Pilates on respiratory muscle strength, balance, overall physical performance, and quality of life. Additionally, a recent systematic review and meta-analysis concluded that Pilates is an effective alternative for improving maximal oxygen uptake (VO2max) values.

Fasting, which involves abstaining from food for extended periods ranging from hours to days, triggers significant metabolic changes referred to as the 'metabolic switch'. One of the most important metabolic shifts during fasting is the increased production of ketone bodies, such as acetoacetic acid, β-hydroxybutyric acid (β-HB), and acetone, in the liver.

Given the heightened vulnerability of obese perimenopausal women to accelerated aging processes and metabolic dysfunction, there is a critical need to identify the most effective lifestyle interventions for this high-risk population. While both Pilates exercise and intermittent fasting show promise in addressing aging-related parameters through different mechanisms, no direct comparative studies have evaluated their relative efficacy on comprehensive physical and metabolic aging markers in obese perimenopausal women.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Their body mass index will be ranged from 30 to 35 kg/m2.
  • Waist hip ratio will be > 1.
  • Total cholesterol (TC) will be > 200 mg/dl.
  • Triglycerides (TG) will be > 150 mg/dl.
  • Low-density lipoprotein (LDL) will be > 100 mg/dl.
  • High-density lipoprotein (HDL) will be < 40 mg/dl.

Exclusion criteria

  • Diabetes type I.
  • Concomitant cardiac disorders.
  • Pregnant or breastfeeding.
  • Eating disorders as Anorexia.
  • Thyroid disorders.
  • Kidney disorders.
  • Severe joint issues as arthritis and post-joint replacement.

Treatment and study plan

pilates exercise

Other

Each exercise will be ranged from 1 to 3 minutes, with a break of 10 seconds. The exercises include: Flat Abs: Pilates Hundred; Flat Abs: Roll-Up; Obliques: Twist and Reach; Lower Back: Shoulder Bridge; Lower Body: Kneeling Side Kicks; Lower Body: Leg Swings; Stamina: Wall Chair.

Intermittent Fasting Diet

Other

This fasting regimen involves fasting for 16 hours each day and limiting eating to an 8-hour window. The 16:8 intermittent fasting protocol is relatively straightforward. It divides the day into two main periods: the fasting period which is 16 hours and the 8 hours eating window .

Primary outcomes

  1. Body weight

    Time frame: 12 weeks

    Weight will be measured in kilograms by weight-height scale for all participants before and after treatment program.

  2. Body mass index

    Time frame: 12 weeks

    It will be measured by weight-height scale by dividing body weight in kilograms by height meter square.

  3. Waist circumference

    Time frame: 12 weeks

    The waist circumference will be measured in centimeters at the narrowest point between xipho-sternum and the iliac crest at the end of a gentle expiration.

  4. Hip circumference

    Time frame: 12 weeks

    Hip circumference will be measured in centimeters at the maximum circumference at the level of the femoral trochanter.

  5. Waist-hip ratio

    Time frame: 12 weeks

    It will be calculated by dividing waist circumference by hip circumference for all participants before and after treatment.

  6. Resting Heart Rate Measurement

    Time frame: 12 weeks

    Resting heart rate (RHR) is the number of heartbeats per minute (bpm) when a person is at complete rest. It is a simple indicator of cardiovascular health. it will be measured by pulse oximeter.

    Normal Range: Adults: 60-100 bpm

  7. Maximum Heart Rate

    Time frame: 12 weeks

    It will be calculated through equation: 220- age

  8. Maximum oxygen consumption (VO2 max)

    Time frame: 12 weeks

    It will be calculated through the equation:VO2 max = 15.3 x (maximum heart rate / resting heart rate).

Secondary outcomes

  1. Assessment of the health-related quality of life

    Time frame: 12 weeks

    It will be assessed using the short form (SF-36) questionnaire, which consists of 36 questions. Answers will be awarded a score on a five-point scale (0-4). The 36-question SF-36 evaluates eight health domains: physical functioning (10 questions), physical role limits (4 questions), bodily pain (2 questions), general health perceptions (5 questions), energy/vitality (4 questions), social function (2 questions), emotional role limits (3 questions), and mental health (5 questions). The scores will be transformed to range from 0 for the worst health to 100 for the ideal health.

  2. Total cholesterol (TC)

    Time frame: 12 weeks

    Total cholesterol (TC) is the total concentration of cholesterol in the blood. Normal range: <200 mg/dL (<5.2 mmol/L)

  3. Triglycerides

    Time frame: Normal: <150 mg/dL (<1.7 mmol/L)

    Triglycerides (TG) are the primary form of fat stored in the body and circulate in the blood as an important source of energy. Elevated triglyceride levels are associated with an increased risk of cardiovascular disease. Normal: <150 mg/dL (<1.7 mmol/L)

  4. High-density lipoprotein

    Time frame: 12 weeks

    High-density lipoprotein is commonly referred to as "good cholesterol" because it transports excess cholesterol from peripheral tissues to the liver for excretion, thereby reducing cardiovascular risk. Normal range for women: <50 mg/dL (<1.3 mmol/L)

  5. Low-density lipoprotein

    Time frame: 12 weeks

    Low-density lipoprotein is often called "bad cholesterol," transports cholesterol from the liver to peripheral tissues. Elevated LDL-C is a major risk factor for atherosclerosis and cardiovascular disease. Normal: <100 mg/dL (<2.6 mmol/L)

  6. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 12 weeks

    It is a widely used index for estimating insulin resistance based on fasting plasma glucose and fasting serum insulin concentrations. It is commonly used in clinical research to assess insulin sensitivity. Normal insulin sensitivity: <2.0

Study contacts

Contact information is provided by the study sponsor or research team.

Hadeel Mohammed, Master

CONTACT

[email protected]

01065489193

Mohamed Abo Eleinien, PHD

CONTACT

[email protected]

01001414404

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Pilates Exercises Versus Intermittent Fasting Diet on Physical and Metabolic Aging Process in Obese Perimenopausal Women

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

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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