- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06834256
Intermittent Fasting vs. High-intensity Interval Training on the Lipid Profile of Obese Individuals. (vs(versus))
February 14, 2025 updated by: Heba Ahmed Mousa, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Cairo, Egypt
- Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (IF group)
Group A followed the intermittent fasting( IF) regime ,with an intervention duration of six weeks for both groups
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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 .
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Experimental: Group B performed High-intensity interval training( HIIT)
High-intensity interval training performed on the treadmill three times weekly, with an intervention duration of six weeks for both groups
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. 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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lipid profile
Time Frame: lipid profile will be measured at baseline, and it will be measured again after six weeks
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A 5 mL fasting venous blood sample was collected following an eight-hour overnight fast, and LDL, HDL, TG, and TC levels were measured.
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lipid profile will be measured at baseline, and it will be measured again after six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
waist circumference
Time Frame: waist circumference will be measured at baseline, and it will be measured again after six weeks
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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
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waist circumference will be measured at baseline, and it will be measured again after six weeks
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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
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It was employed to ascertain the cardiovascular disease risk over ten years.
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The Framingham risk score (FRS) will be measured at baseline, and it will be measured again after six weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heba Mousa, lecturer, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Nazari 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Actual)
March 2, 2024
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
February 14, 2025
First Submitted That Met QC Criteria
February 14, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 14, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004625
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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