Clinical trial NCT07002970: Effect of Aerobic Exercise and Mediterranean Diet on Obese Patients
Official title: Combined Effect of Aerobic Exercise and Mediterranean Diet on Inflammatory Markers and Quality of Life in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: aerobic exercise
inflammatory markers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: All study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine.

Both groups received a Mediterranean diet for 12 weeks tailored according to patients' caloric needs

Detailed description: All study group patients performed aerobic exercise on a treadmill approved by the American College of Sports Medicine. The program started with a warming-up phase through walking on a treadmill for 3-5 minutes at a slow speed. Then, 10-30 minutes of aerobic exercise training with moderate intensity (60-70% of maximum heart rate) and 10 minutes of cooling down with low speed and without inclination. Participants had 3 sessions/week for 3 months with close supervision of a physical therapist.

Both groups received a Mediterranean diet for 12 weeks tailored to patients' caloric needs. They received instructions about the consumption of olive oil as added lipid, the consumption of nuts and olives as snacks, daily high consumption of vegetables, fruits, and whole grains, dairy products, bi-weekly consumption of legumes, bi-weekly consumption of fish, and monthly consumption of meat. The main beneficial components of the Mediterranean diet are monounsaturated fats such as oleic acid in olive oil, polyunsaturated fats such as omega-3, high amounts of flavonoids and antioxidants found in fruits and vegetables, and high amounts of fiber found mainly in foods with a low glycemic index

Eligibility criteria: Inclusion Criteria:

* Obese patients with BMI ranged from 30-39.9 kg/m 2.
* Their age was from 35 to 45 years old.
* Both genders.
* Stable vital signs (blood pressure, respiratory rate and temperature)
* Abdominal obesity measurements according to American heart association)
* Obese patients have one or more abnormal value of lipids profile.
* All patients with sedentary life style.
* All patients had insulin resistance

Exclusion Criteria:

* Rheumatic, neurologic, cardiovascular, respiratory, renal, lung problems, malignant tumors, and undiagnosed fever, which would prevent them from participating in aerobic exercises.
* Knee injury or knee surgery during the past six month or having a history of joint replacement or fracture or hereditary or acquired musculoskeletal disorders in lower limb.
* Major vision disorders.
* Drugs that would affect metabolism or balance.
* Assistive devices for walking.
* Pregnancy or breast feeding, and post-partum 12 months.
* Abdominal or rectal anus surgery.

Primary outcomes:
measure: Short Form Quality of Life Questionnaire (SF-36)
timeFrame: 12 weeks
Secondary outcomes:
measure: Laboratory Measurements
timeFrame: 12 weeks
measure: Blood Pressure Measures
timeFrame: 12 weeks
measure: body weight
timeFrame: 12 weeks
measure: height
timeFrame: 12 weeks
measure: waist and hip circumferences
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: faculty of physical Cairo university
name: mai salah, master
role: PRINCIPAL_INVESTIGATOR
References: