NCT06834256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 14, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

Intermittent Fasting,High-Intensity Training,,Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    lipid profile will be measured at baseline, and it will be measured again after six weeks

Secondary Outcomes (2)

  • waist circumference

    waist circumference will be measured at baseline, and it will be measured again after six weeks

  • The Framingham risk score (FRS)

    The Framingham risk score (FRS) will be measured at baseline, and it will be measured again after six weeks

Study Arms (2)

Group A (IF group)

EXPERIMENTAL

Group A followed the intermittent fasting( IF) regime ,with an intervention duration of six weeks for both groups

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

Behavioral: low volume high intensity interval training

Interventions

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 .

Group A (IF group)

. 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.

Group B performed High-intensity interval training( HIIT)

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heba Mousa, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

July 1, 2023

Primary Completion

March 2, 2024

Study Completion

May 1, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations