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Completed

NCT Number: NCT07834099

Comparative Effects of Aerobic Exercise and Keto Diet on Obesity-Related Biomarkers in Obese Women With High (WHR)

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

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Key information

Conditions

Keto Diet Aerobic Exercise Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Disorder) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 11828, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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Treatment and study plan

Keto Diet

Behavioral

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 Exercise

Other

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 diet

Combination 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

Primary outcomes

  1. free testosterone

    Time frame: pre intervention and post intervention (after 3 months)

    a blood test to measure the amount of free testosterone

  2. 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

  3. IL6

    Time frame: pre intervention and post intervention (after 3 months)

    a blood test to measure the level of interleukin6

  4. HMWA

    Time frame: pre intervention and post intervention (after 3 months)

    a blood test to measure the level of high molecular weight adiponectin

  5. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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