Obesityvs(versus)NCT06834256
Intermittent Fasting vs. High-intensity Interval Training on the Lipid Profile of Obese Individuals.
A study testing intermittent fasting and low volume high intensity interval training in people with Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
we aimed to ascertain the effect of intermittent fasting (IF) vs. high-intensity interval training (HIIT) on the lipid profile and waist circumference (WC) of obese individuals. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Obesity
- What is being tested?
- intermittent fasting and low volume high intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 May 2024
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria were as follows: (1) A BMI of 30 -40 kg/m2; (2) abnormal lipid profile, with a TC level > 200 mg/dL, an LDL > 100 mg/dL, a TC level > 150 mg/dL, and an HDL < 40 mg/dL; (3) steady vital signs, including blood pressure, respiration rate, and temperature at a baseline level.
Who cannot join
- The exclusion criteria included patients with the following medical conditions: cancer, unstable angina, uncontrolled cardiac rhythm, decompensated heart failure, persistent systolic blood pressure > 200 mmHg, persistent diastolic blood pressure > 120 mmHg, acute pericarditis or myocarditis, severe restrictive lung disease, chronic chest infection, severe obstructive lung disease, pregnant women, neurological disorders that affect balance and mentality (e.g., epilepsy), orthopedic or neurological problems that interfere with exercises, unstable endocrinal disorders, congenital or acquired lower limb deformity, kidney disease, infectious disease, immune disease, hearing impairment or mental disorder, uncontrolled T2DM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Fasting vs. High-Intensity Interval Training on Lipid Profile in Obese Patients
we aimed to ascertain the effect of intermittent fasting (IF) vs. high-intensity interval training (HIIT) on the lipid profile and waist circumference (WC) of obese individuals.
Read the detailed description
Subjects and Methods: This study included 40 obese individuals of both genders aged 35-50 years with an abnormal lipid profile. The patients were allocated at random to either Group A or B, with both groups receiving medical treatment. Group A followed the IF regime, while Group B performed HIIT on the treadmill three times weekly, with an intervention duration of six weeks for both groups. Body mass index (BMI), WC, levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), alongside the Framingham risk score (FRS) were the evaluated variables.
- Conditions
- Obesity
- Being tested
- intermittent fasting, low volume high intensity interval training
- Keywords
- Intermittent Fasting,High-Intensity Training,,Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fastingBehavioural
Group A participants followed the IF diet for 6 weeks . intermittent fasting , specifically time-restricted feeding (TRF), involves consuming all of one's energy requirements inside an 8-h.The fasting interval was designated as 16 h, and the other 8-h was the eating period . During the 8-h eating window, the patient consumes a well-balanced meal consisting of 55%-65% carbs, 7%-20% protein, and 15%-30% fat .
low volume high intensity interval trainingBehavioural
. Group B engaged in low-volume HIIT exercise (aerobic activity) three times weekly for six weeks. The exercise routine consisted of a 5-min warm-up phase at 70% of MHR, followed by four intervals of 2-min maximum effort cycling sessions (4 × 2 HIIT) compared to a sub-maximal workload at 85%-90% of MHR. The participants engaged in four work bouts, with each bout lasting around 4 min and followed by a 4-min rest period. During the workouts, the participants maintained an HR of 60%-70% of their MHR. This resulted in 8 min of intense physical activity during each training session. Additionally, there was a 5-min cooling down phase at 70% of the MHR. The treatment's intensity was adapted based on the modified Bruce protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group A (IF group) | Experimental | Group A followed the intermittent fasting( IF) regime ,with an intervention duration of six weeks for both groups Receives: Behavioral: intermittent fasting |
| Group B performed High-intensity interval training( HIIT) | Experimental | High-intensity interval training performed on the treadmill three times weekly, with an intervention duration of six weeks for both groups Receives: Behavioral: low volume high intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid profile
A 5 mL fasting venous blood sample was collected following an eight-hour overnight fast, and LDL, HDL, TG, and TC levels were measured.
Measured: lipid profile will be measured at baseline, and it will be measured again after six weeks
Secondary outcomes (2)
waist circumference
Utilizing tape measurements to measure WC.A WC > 40 inches (102 cm) in males and > 35 inches (88 cm) in women indicated an elevated risk for cardiometabolic disorders
Measured: waist circumference will be measured at baseline, and it will be measured again after six weeks
The Framingham risk score (FRS)
It was employed to ascertain the cardiovascular disease risk over ten years.
Measured: The Framingham risk score (FRS) will be measured at baseline, and it will be measured again after six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jul 2023
- Primary completion2 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Mousa, Cairo University
- Investigators
- Heba Mousa, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834256
- Sponsor's protocol ID
- P.T.REC/012/004625
- Acronym
- vs(versus)
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nussbaumerova B, Rosolova H. Obesity and Dyslipidemia. Curr Atheroscler Rep. 2023 Dec;25(12):947-955. doi: 10.1007/s11883-023-01167-2. Epub 2023 Nov 18.
PubMed 37979064Nazari M, Minasian V, Hovsepian S. Effects of Two Types of Moderate- and High-Intensity Interval Training on Serum Salusin-alpha and Salusin-beta Levels and Lipid Profile in Women with Overweight/Obesity. Diabetes Metab Syndr Obes. 2020 Apr 24;13:1385-1390. doi: 10.2147/DMSO.S248476. eCollection 2020.
PubMed 32425570
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting vs. High-Intensity Interval Training on Lipid Profile in Obese Patients
- ClinicalTrials.gov ID
- NCT06834256
- Acronym / sponsor ID
- vs(versus) / P.T.REC/012/004625
- Conditions
- Obesity
- Keywords
- Intermittent Fasting,High-Intensity Training,,Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Feb 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.
we aimed to ascertain the effect of intermittent fasting (IF) vs. high-intensity interval training (HIIT) on the lipid profile and waist circumference (WC) of obese individuals.
Detailed description
Subjects and Methods: This study included 40 obese individuals of both genders aged 35-50 years with an abnormal lipid profile. The patients were allocated at random to either Group A or B, with both groups receiving medical treatment. Group A followed the IF regime, while Group B performed HIIT on the treadmill three times weekly, with an intervention duration of six weeks for both groups. Body mass index (BMI), WC, levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), alongside the Framingham risk score (FRS) were the evaluated variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (IF group) | Experimental | Behavioral: intermittent fastingGroup A followed the intermittent fasting( IF) regime ,with an intervention duration of six weeks for both groups |
| Group B performed High-intensity interval training( HIIT) | Experimental | Behavioral: low volume high intensity interval trainingHigh-intensity interval training performed on the treadmill three times weekly, with an intervention duration of six weeks for both groups |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria were as follows: (1) A BMI of 30 -40 kg/m2; (2) abnormal lipid profile, with a TC level > 200 mg/dL, an LDL > 100 mg/dL, a TC level > 150 mg/dL, and an HDL < 40 mg/dL; (3) steady vital signs, including blood pressure, respiration rate, and temperature at a baseline level.
Key exclusion criteria (1 listed)
- The exclusion criteria included patients with the following medical conditions: cancer, unstable angina, uncontrolled cardiac rhythm, decompensated heart failure, persistent systolic blood pressure > 200 mmHg, persistent diastolic blood pressure > 120 mmHg, acute pericarditis or myocarditis, severe restrictive lung disease, chronic chest infection, severe obstructive lung disease, pregnant women, neurological disorders that affect balance and mentality (e.g., epilepsy), orthopedic or neurological problems that interfere with exercises, unstable endocrinal disorders, congenital or acquired lower limb deformity, kidney disease, infectious disease, immune disease, hearing impairment or mental disorder, uncontrolled T2DM.
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 |
|---|---|---|
| intermittent fastingGroup A participants followed the IF diet for 6 weeks . intermittent fasting , specifically time-restricted feeding (TRF), involves consuming all of one's energy requirements inside an 8-h.The fasting interval was designated as 16 h, and the other 8-h was the eating period . During the 8-h eating window, the patient consumes a well-balanced meal consisting of 55%-65% carbs, 7%-20% protein, and 15%-30% fat . | Behavioural | Group A (IF group) |
| low volume high intensity interval training. Group B engaged in low-volume HIIT exercise (aerobic activity) three times weekly for six weeks. The exercise routine consisted of a 5-min warm-up phase at 70% of MHR, followed by four intervals of 2-min maximum effort cycling sessions (4 × 2 HIIT) compared to a sub-maximal workload at 85%-90% of MHR. The participants engaged in four work bouts, with each bout lasting around 4 min and followed by a 4-min rest period. During the workouts, the participants maintained an HR of 60%-70% of their MHR. This resulted in 8 min of intense physical activity during each training session. Additionally, there was a 5-min cooling down phase at 70% of the MHR. The treatment's intensity was adapted based on the modified Bruce protocol. | Behavioural | Group B performed High-intensity interval training( HIIT) |
Primary outcome
lipid profile
Time frame: lipid profile will be measured at baseline, and it will be measured again after six weeks
A 5 mL fasting venous blood sample was collected following an eight-hour overnight fast, and LDL, HDL, TG, and TC levels were measured.
2 secondary outcomes
waist circumference
Time frame: waist circumference will be measured at baseline, and it will be measured again after six weeks
The Framingham risk score (FRS)
Time frame: The Framingham risk score (FRS) will be measured at baseline, and it will be measured again after six 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 19 Feb 2025.
- Results publication: PubMed 37979064Nussbaumerova B, Rosolova H. Obesity and Dyslipidemia. Curr Atheroscler Rep. 2023 Dec;25(12):947-955. doi: 10.1007/s11883-023-01167-2. Epub 2023 Nov 18.
- Results publication: PubMed 32425570Nazari M, Minasian V, Hovsepian S. Effects of Two Types of Moderate- and High-Intensity Interval Training on Serum Salusin-alpha and Salusin-beta Levels and Lipid Profile in Women with Overweight/Obesity. Diabetes Metab Syndr Obes. 2020 Apr 24;13:1385-1390. doi: 10.2147/DMSO.S248476. eCollection 2020.
Related trials for Obesity
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Obesity
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.
Heba Mousa, lecturer principal investigator
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 intermittent fasting and low volume high intensity interval training 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 1 inclusion and 1 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 19 Feb 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?
lipid profile (time frame: lipid profile will be measured at baseline, and it will be measured again after six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06834256, which also lists 2 linked publications.
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 19 Feb 2025.