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

June 28, 2026 updated by: Hadeel Adil Mohammed, Cairo University

Effect of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Al Fayyum, Egypt
        • Hadeel Adil Mohamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates exercise group
The participants will be treated with Pilates exercises, 4 times per week, 60 minutes per session, for 12 weeks.
Other: Pilates exercise
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.
Experimental: Intermittent Fasting Diet
The participants will follow intermittent fasting diet for 12 weeks.
Other: Intermittent Fasting Diet
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 .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 12 weeks
Weight will be measured in kilograms by weight-height scale for all participants before and after treatment program.
12 weeks
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.
12 weeks
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.
12 weeks
Hip circumference
Time Frame: 12 weeks
Hip circumference will be measured in centimeters at the maximum circumference at the level of the femoral trochanter.
12 weeks
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.
12 weeks
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
12 weeks
Maximum Heart Rate
Time Frame: 12 weeks
It will be calculated through equation: 220- age
12 weeks
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).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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)
12 weeks
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)
Normal: <150 mg/dL (<1.7 mmol/L)
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)
12 weeks
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)
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mohamed Awad, Professor, Cairo University
  • Study Director: Doaa Osman, As Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/006542

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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