ObesityNCT07683286
Pilates Exercises Versus Intermittent Fasting Diet on Physical and Metabolic Aging Process in Obese Perimenopausal Women
A study testing Pilates exercise and Intermittent Fasting Diet in people with Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of pilates exercises versus intermittent fasting diet on physical and metabolic aging parameters in obese perimenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Pilates exercise and Intermittent Fasting Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to 16 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Pilates exercise, Intermittent Fasting Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exerciseOther
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 DietOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise group | Experimental | The participants will be treated with Pilates exercises, 4 times per week, 60 minutes per session, for 12 weeks. Receives: Other: Pilates exercise |
| Intermittent Fasting Diet | Experimental | The participants will follow intermittent fasting diet for 12 weeks. Receives: Other: Intermittent Fasting Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight will be measured in kilograms by weight-height scale for all participants before and after treatment program.
Measured: 12 weeks
Body mass index
It will be measured by weight-height scale by dividing body weight in kilograms by height meter square.
Measured: 12 weeks
Waist circumference
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.
Measured: 12 weeks
Hip circumference
Hip circumference will be measured in centimeters at the maximum circumference at the level of the femoral trochanter.
Measured: 12 weeks
Waist-hip ratio
It will be calculated by dividing waist circumference by hip circumference for all participants before and after treatment.
Measured: 12 weeks
Resting Heart Rate Measurement
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
Measured: 12 weeks
Maximum Heart Rate
It will be calculated through equation: 220- age
Measured: 12 weeks
Maximum oxygen consumption (VO2 max)
It will be calculated through the equation:VO2 max = 15.3 x (maximum heart rate / resting heart rate).
Measured: 12 weeks
Secondary outcomes (6)
Assessment of the health-related quality of life
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.
Measured: 12 weeks
Total cholesterol (TC)
Total cholesterol (TC) is the total concentration of cholesterol in the blood. Normal range: <200 mg/dL (<5.2 mmol/L)
Measured: 12 weeks
Triglycerides
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)
Measured: Normal: <150 mg/dL (<1.7 mmol/L)
High-density lipoprotein
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)
Measured: 12 weeks
Low-density lipoprotein
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)
Measured: 12 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion16 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Adil Mohammed, Cairo University
- Investigators
- Doaa Osman, As Professor, Study director, Cairo UniversityMohamed Awad, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683286
- Sponsor's protocol ID
- P.T.REC/012/006542
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises Versus Intermittent Fasting Diet on Physical and Metabolic Aging Process in Obese Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07683286
- Acronym / sponsor ID
- P.T.REC/012/006542
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 16 Jan 2027 (estimated)
- First posted
- 6 Jul 2026 (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 aims to compare the effect of pilates exercises versus intermittent fasting diet on physical and metabolic aging parameters in obese perimenopausal women.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise group | Experimental | Other: Pilates exerciseThe participants will be treated with Pilates exercises, 4 times per week, 60 minutes per session, for 12 weeks. |
| Intermittent Fasting Diet | Experimental | Other: Intermittent Fasting DietThe participants will follow intermittent fasting diet for 12 weeks. |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Diabetes type I.
- Concomitant cardiac disorders.
- Pregnant or breastfeeding.
- Eating disorders as Anorexia.
- Thyroid disorders.
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 |
|---|---|---|
| Pilates exerciseEach 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. | Other | Pilates exercise group |
| Intermittent Fasting DietThis 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 . | Other | Intermittent Fasting Diet |
Primary outcome
Body weight
Time frame: 12 weeks
Weight will be measured in kilograms by weight-height scale for all participants before and after treatment program.
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.
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.
Hip circumference
Time frame: 12 weeks
Hip circumference will be measured in centimeters at the maximum circumference at the level of the femoral trochanter.
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.
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
Maximum Heart Rate
Time frame: 12 weeks
It will be calculated through equation: 220- age
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).
6 secondary outcomes
Assessment of the health-related quality of life
Time frame: 12 weeks
Total cholesterol (TC)
Time frame: 12 weeks
Triglycerides
Time frame: Normal: <150 mg/dL (<1.7 mmol/L)
High-density lipoprotein
Time frame: 12 weeks
Low-density lipoprotein
Time frame: 12 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Doaa Osman, As Professor study director
Cairo University
Mohamed Awad, Professor study chair
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 Pilates exercise and Intermittent Fasting Diet in people with Obesity, 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadeel Mohammed, Master (01065489193, hadeltv@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 weeks). The study lists 8 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 6 Jul 2026.