Clinical trial NCT06834256: Intermittent Fasting vs. High-intensity Interval Training on the Lipid Profile of Obese Individuals.
Official title: Intermittent Fasting vs. High-Intensity Interval Training on Lipid Profile in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Intermittent Fasting,High-Intensity Training,,Obesity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: lipid profile
timeFrame: lipid profile will be measured at baseline, and it will be measured again after six weeks
Secondary outcomes:
measure: waist circumference
timeFrame: waist circumference will be measured at baseline, and it will be measured again after six weeks
measure: The Framingham risk score (FRS)
timeFrame: The Framingham risk score (FRS) will be measured at baseline, and it will be measured again after six weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Heba Mousa, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.