Keto DietNCT07834099
Comparative Effects of Aerobic Exercise and Keto Diet on Obesity-Related Biomarkers in Obese Women With High (WHR)
A study testing Keto diet, Aerobic exercise and Aerobic exercise + keto diet in people with Keto Diet and Aerobic Exercise, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to compare between aerobic exercise and keto diet in their effect on obesity related biomarkers (testosterone, TNF alpha, IL6, HMW, BMI, WHR) in 120 obese women with high WHR. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Keto Diet, Aerobic Exercise, Obesity (Disorder)
- What is being tested?
- Keto diet, Aerobic exercise and Aerobic exercise + keto diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2026to 17 Jul 2026
- 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 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: sedentary obese premenopausal woman aged 35-50 years with a BMI of 30-34.9 and a WHR above 0.85, and with none of the exclusion criteria -
Exclusion Criteria: are subjects losing even one of the inclusion criteria or having any health condition that could hinder their ability to exercise or engage in the ketogenic diet protocol.
-
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this study is to compare between aerobic exercise and keto diet in their effect on obesity related biomarkers (testosterone, TNF alpha, IL6, HMW, BMI, WHR) in 120 obese women with high WHR. all subjects followed the given instructions strictly during the study duration, regarding the assessment and treatment procedure, all participants evaluated under the same environmental conditions
Read the detailed description
Obesity affects hormones in a multidimensional way through creating a vicious cycle of metabolic, endocrine and inflammatory disorders. Combining Obesity with physical inactivity and the subsequent decrease in Insulin sensitivity is the key mechanism leading to type2 diabetes, systemic low grade inflammation, disruption of glucose uptake in peripheral tissues and increased hepatic glucose production leading to more fat deposition in adipose tissue and other organs. A key challenge is to develop individualized therapeutic strategies that address the unique interactions between hormones, diet and lifestyle. Interventions should include both pharmacotherapy and behavioral changes, such as dietary modification and regular physical activity The KD involves a diet that replaces glucose with ketone bodies and is effective in numerous diseases such as metabolic disorders, epileptic seizures, autosomal dominant polycystic disease of the kidney, cancers, peripheral neuropathy, and skeletal muscle atrophy. It exerts anti-inflammatory effects and induces up-regulation of BHB levels that is associated with decreased levels of pro-inflammatory cytokines Regular exercise positively impacts antioxidant enzyme activity and influences the immune system by increasing T-cell count and decreasing receptors linked to inflammatory cytokine production. It also improves insulin sensitivity, contributing to euglycemia, improves vasodilatation, angiogenesis, blood flow, reduces hypoxia, macrophage infiltration, and suppresses chronic inflammation in adipose tissue. the Purpose of the study was To assess the effect of aerobic exercise versus a ketogenic diet protocol on obesity related biomarkers ( testosterone, TNF alpha, IL6, HMW adiponectin levels) in sedentary obese women with high WHR. 120 sedentary obese premenopausal women aged 35-50 years old with BMI of 30-34.9, WHR above 0.85 were incorporated in three groups, 40 women for each.
All subjects were diagnosed with obesity, BMI of 30-34.9 and WHR above 0.85.
- Conditions
- Keto Diet, Aerobic Exercise, Obesity (Disorder)
- Being tested
- Keto diet, Aerobic exercise, Aerobic exercise + keto diet
- Keywords
- aerobic exercise, obesity, keto diet, systemic low grade inflammation, obesity related biomarkers, WHR
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keto dietBehavioural
Dietary intervention protocol:- ketogenic diet primarily emphasizes fat as the principal fuel source with consideration for fat quality and healthier fat sources such as plant oils, nuts, seeds, and oily fish, along with lean proteins including skinless poultry, veal, and lean beef. Fat sources focused on foods rich in monounsaturated fatty acids (MUFA), such as olive oil and avocado, as well as polyunsaturated fatty acids (PUFA) from canola and flaxseed oil, nuts and seeds, and fatty fish including salmon, herring, mackerel, and sardines. saturated fats (e.g., lard, butter, cream, pork, offal, and beef) are also allowed. providing about 50-100 g of carbohydrates per day emphasizing the quality of foods consumed. Daily energy intake was divided into three meals, each including a source of protein, fat, and vegetables. Protein sources included eggs, cheeses, lean poultry, and beef. Each meal also incorporated non-starchy vegetables, including tomatoes, cucumbers, peppers, spin
Aerobic exerciseOther
the exercise programme followed these characteristics: frequency: 3-5 times/week along the whole study period (12 weeks), intensity: 65- 70% of the maximal heart rate (220 - age x 70/100), duration: 50 min. it included (10 min warming up in form of exercise movements (stretching and flexibility) in standing position, 30 min active phase in form of walking on a computerized treadmill, 10 min cooling down in form of exercise movements (stretching and flexibility) performed in the seated position). All the patients could drink water during their training. Subjects in this group were instructed not to change their habitual diet all over the study period
Aerobic exercise + keto dietCombination product
aerobic exercise following these characteristics: frequency: 3-5 times/week along the whole study period (12 weeks), intensity: 65- 70% of the maximal heart rate (220 - age x 70/100), duration: 50 min. including (10 min warming up in form of exercise movements (stretching and flexibility) in standing position, 30 min active phase in form of walking on a computerized treadmill, 10 min cooling down in form of exercise movements (stretching and flexibility) performed in the seated position. All the patients could drink water during their training. Subjects in this group were instructed not to change their habitual diet all over the study period
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Experimental | 40 subjects performed a specialized programme of aerobic exercise with frequency of 3-5 times a week Receives: Other: Aerobic exercise |
| keto diet group | Experimental | 40 subjects performed a specialized programme of a ketogenic diet protocol throughout the whole study period Receives: Behavioral: Keto diet |
| combined | Experimental | 40 subjects performed the same programme ketogenic diet combined with the same programme of aerobic exercise Receives: Combination Product: Aerobic exercise + keto diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
free testosterone
a blood test to measure the amount of free testosterone
Measured: pre intervention and post intervention (after 3 months)
TNF alpha
a blood test to measure the level of tumour necrosis factor alpha level
Measured: pre intervention and post intervention (after 3 months)
IL6
a blood test to measure the level of interleukin6
Measured: pre intervention and post intervention (after 3 months)
HMWA
a blood test to measure the level of high molecular weight adiponectin
Measured: pre intervention and post intervention (after 3 months)
BMI
body mass index that can be calculated from the equation BMI = weight (kg) ÷ [height (m)]²
Measured: pre intervention and post intervention (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Feb 2026
- Primary completion17 Jun 2026
- Study completion17 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keto DietStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Saeed Aly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834099
- Sponsor's protocol ID
- P.T.REC/012/006330
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Aerobic Exercise and Keto Diet on Obesity-Related Biomarkers in Obese Women With High (WHR)
- ClinicalTrials.gov ID
- NCT07834099
- Acronym / sponsor ID
- P.T.REC/012/006330
- Conditions
- Keto Diet, Aerobic Exercise, Obesity (Disorder)
- Keywords
- aerobic exercise, obesity, keto diet, systemic low grade inflammation, obesity related biomarkers, WHR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 22 Sep 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.
the aim of this study is to compare between aerobic exercise and keto diet in their effect on obesity related biomarkers (testosterone, TNF alpha, IL6, HMW, BMI, WHR) in 120 obese women with high WHR. all subjects followed the given instructions strictly during the study duration, regarding the assessment and treatment procedure, all participants evaluated under the same environmental conditions
Detailed description
Obesity affects hormones in a multidimensional way through creating a vicious cycle of metabolic, endocrine and inflammatory disorders. Combining Obesity with physical inactivity and the subsequent decrease in Insulin sensitivity is the key mechanism leading to type2 diabetes, systemic low grade inflammation, disruption of glucose uptake in peripheral tissues and increased hepatic glucose production leading to more fat deposition in adipose tissue and other organs. A key challenge is to develop individualized therapeutic strategies that address the unique interactions between hormones, diet and lifestyle. Interventions should include both pharmacotherapy and behavioral changes, such as dietary modification and regular physical activity The KD involves a diet that replaces glucose with ketone bodies and is effective in numerous diseases such as metabolic disorders, epileptic seizures, autosomal dominant polycystic disease of the kidney, cancers, peripheral neuropathy, and skeletal muscle atrophy. It exerts anti-inflammatory effects and induces up-regulation of BHB levels that is associated with decreased levels of pro-inflammatory cytokines Regular exercise positively impacts antioxidant enzyme activity and influences the immune system by increasing T-cell count and decreasing receptors linked to inflammatory cytokine production. It also improves insulin sensitivity, contributing to euglycemia, improves vasodilatation, angiogenesis, blood flow, reduces hypoxia, macrophage infiltration, and suppresses chronic inflammation in adipose tissue. the Purpose of the study was To assess the effect of aerobic exercise versus a ketogenic diet protocol on obesity related biomarkers ( testosterone, TNF alpha, IL6, HMW adiponectin levels) in sedentary obese women with high WHR. 120 sedentary obese premenopausal women aged 35-50 years old with BMI of 30-34.9, WHR above 0.85 were incorporated in three groups, 40 women for each.
All subjects were diagnosed with obesity, BMI of 30-34.9 and WHR above 0.85.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Experimental | Other: Aerobic exercise40 subjects performed a specialized programme of aerobic exercise with frequency of 3-5 times a week |
| keto diet group | Experimental | Behavioral: Keto diet40 subjects performed a specialized programme of a ketogenic diet protocol throughout the whole study period |
| combined | Experimental | Combination Product: Aerobic exercise + keto diet40 subjects performed the same programme ketogenic diet combined with the same programme of aerobic exercise |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Keto dietDietary intervention protocol:- ketogenic diet primarily emphasizes fat as the principal fuel source with consideration for fat quality and healthier fat sources such as plant oils, nuts, seeds, and oily fish, along with lean proteins including skinless poultry, veal, and lean beef. Fat sources focused on foods rich in monounsaturated fatty acids (MUFA), such as olive oil and avocado, as well as polyunsaturated fatty acids (PUFA) from canola and flaxseed oil, nuts and seeds, and fatty fish including salmon, herring, mackerel, and sardines. saturated fats (e.g., lard, butter, cream, pork, offal, and beef) are also allowed. providing about 50-100 g of carbohydrates per day emphasizing the quality of foods consumed. Daily energy intake was divided into three meals, each including a source of protein, fat, and vegetables. Protein sources included eggs, cheeses, lean poultry, and beef. Each meal also incorporated non-starchy vegetables, including tomatoes, cucumbers, peppers, spin | Behavioural | keto diet group |
| Aerobic exercisethe exercise programme followed these characteristics: frequency: 3-5 times/week along the whole study period (12 weeks), intensity: 65- 70% of the maximal heart rate (220 - age x 70/100), duration: 50 min. it included (10 min warming up in form of exercise movements (stretching and flexibility) in standing position, 30 min active phase in form of walking on a computerized treadmill, 10 min cooling down in form of exercise movements (stretching and flexibility) performed in the seated position). All the patients could drink water during their training. Subjects in this group were instructed not to change their habitual diet all over the study period | Other | aerobic exercise |
| Aerobic exercise + keto dietaerobic exercise following these characteristics: frequency: 3-5 times/week along the whole study period (12 weeks), intensity: 65- 70% of the maximal heart rate (220 - age x 70/100), duration: 50 min. including (10 min warming up in form of exercise movements (stretching and flexibility) in standing position, 30 min active phase in form of walking on a computerized treadmill, 10 min cooling down in form of exercise movements (stretching and flexibility) performed in the seated position. All the patients could drink water during their training. Subjects in this group were instructed not to change their habitual diet all over the study period | Combination product | combined |
Primary outcome
free testosterone
Time frame: pre intervention and post intervention (after 3 months)
a blood test to measure the amount of free testosterone
TNF alpha
Time frame: pre intervention and post intervention (after 3 months)
a blood test to measure the level of tumour necrosis factor alpha level
IL6
Time frame: pre intervention and post intervention (after 3 months)
a blood test to measure the level of interleukin6
HMWA
Time frame: pre intervention and post intervention (after 3 months)
a blood test to measure the level of high molecular weight adiponectin
BMI
Time frame: pre intervention and post intervention (after 3 months)
body mass index that can be calculated from the equation BMI = weight (kg) ÷ [height (m)]²
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 22 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keto diet, Aerobic exercise and Aerobic exercise + keto diet in people with Keto Diet and Aerobic Exercise, 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?
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 22 Sep 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?
free testosterone (time frame: pre intervention and post intervention (after 3 months)). The study lists 5 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 22 Sep 2026.