ObesityNCT07002970
Effect of Aerobic Exercise and Mediterranean Diet on Obese Patients
A study testing aerobic exercise program and Mediterranean diet in people with Obesity, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- aerobic exercise program and Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 May 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Aerobic Exercise and Mediterranean Diet on Inflammatory Markers and Quality of Life in Obese Patients
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
Read the 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
- Conditions
- Obesity
- Being tested
- aerobic exercise program, Mediterranean diet
- Keywords
- aerobic exercise, inflammatory markers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise programOther
All study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine.
Mediterranean dietOther
received a Mediterranean diet for 12 weeks tailored according to patients caloric needs
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | aerobic exercise program and Mediterranean diet Receives: Other: aerobic exercise program; Other: Mediterranean diet |
| control group | Active comparator | Mediterranean diet Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Quality of Life Questionnaire (SF-36)
To measure the health related quality of life (HRQOL)in obese patient. SF-36 (version 2.0) is a 36-item measure of generic HRQOL in which 35 questions are transformed into eight dimensions; physical functioning, role limitation to physical problems, bodily pain, general health, vitality, social functioning, role limitations to emotional problems, and mental health Scores on all eight dimensions range from zero to 100, where higher scores represent better HRQOL
Measured: 12 weeks
Secondary outcomes (5)
Laboratory Measurements
After a 12-hour overnight fast, venous blood samples were collected from each participant in all participants before and after 12 weeks of treatment to measure, LDL, HDL, total cholesterol, TG levels milligrams per deciliter (mg/dL) and fasting blood glucose (FBG) measured in mg/dL (milligrams per deciliter) ,C-reactive protein (CRP) measured in milligrams per liter (mg/L), and (ESR) was measured in millimeters per hour (mm/hr) and fasting serum insulin measured and reported in micro International Units per milliliter (uIU/mL) by commercially available kits. All samples were drawn between 8 and 10 a.m. for later analysis.
Measured: 12 weeks
Blood Pressure Measures
Systolic and diastolic blood pressures were measured for each participant before and after 12 weeks of treatment
Measured: 12 weeks
body weight
Body weight was measured for each participant in kilograms
Measured: 12 weeks
height
body height was measured for each participant in meters
Measured: 12 weeks
waist and hip circumferences
waist and hip circumferences were measured for each participant in centimeter
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 posted4 Jun 2025
- Study start1 Oct 2023
- Primary completion1 May 2025
- Study completion1 May 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Salah, Cairo University
- Investigators
- mai salah, master, Principal investigator, faculty of physical Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002970
- Sponsor's protocol ID
- P.T.REC/012/004630
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Aerobic Exercise and Mediterranean Diet on Inflammatory Markers and Quality of Life in Obese Patients
- ClinicalTrials.gov ID
- NCT07002970
- Acronym / sponsor ID
- P.T.REC/012/004630
- Conditions
- Obesity
- Keywords
- aerobic exercise, inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 4 Jun 2025 (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.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: aerobic exercise program, Other: Mediterranean dietaerobic exercise program and Mediterranean diet |
| control group | Active comparator | Other: Mediterranean dietMediterranean diet |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| aerobic exercise programAll study group patients performed aerobic exercise on a treadmill. approved by the American College of Sports Medicine. | Other | study group |
| Mediterranean dietreceived a Mediterranean diet for 12 weeks tailored according to patients caloric needs | Other | control group, study group |
Primary outcome
Short Form Quality of Life Questionnaire (SF-36)
Time frame: 12 weeks
To measure the health related quality of life (HRQOL)in obese patient. SF-36 (version 2.0) is a 36-item measure of generic HRQOL in which 35 questions are transformed into eight dimensions; physical functioning, role limitation to physical problems, bodily pain, general health, vitality, social functioning, role limitations to emotional problems, and mental health Scores on all eight dimensions range from zero to 100, where higher scores represent better HRQOL
5 secondary outcomes
Laboratory Measurements
Time frame: 12 weeks
Blood Pressure Measures
Time frame: 12 weeks
body weight
Time frame: 12 weeks
height
Time frame: 12 weeks
waist and hip circumferences
Time frame: 12 weeks
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 4 Jun 2025.
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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.
mai salah, master principal investigator
faculty of physical 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 aerobic exercise program and Mediterranean 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 8 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: finished, as of the sponsor's last update on 4 Jun 2025. 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?
Short Form Quality of Life Questionnaire (SF-36) (time frame: 12 weeks). 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 4 Jun 2025.