Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome

Not Applicable

Completed

• Conditions: Intermittent Islamic Fasting in Metabolic Syndrome

• Registration Number: NCT06805526
• Lead Sponsor: Zagazig University

Brief Summary

Metabolic syndrome doubles the risk of developing cardiovascular diseases and type 2 diabetes mellitus. Intermittent Islamic fasting is an effective health strategy associated with various benefits. Objectives: to compare effect of Intermittent Islamic fasting with lifestyle modification versus lifestyle modification only on weight management, blood pressure, blood glucose and lipid profile among a group of metabolic syndrome patients.

Detailed Description

Metabolic Syndrome (MetS), also called "Syndrome X" or "insulin resistance syndrome," describes a common condition characterized by high blood pressure, elevated triglycerides, central obesity, and low HDL cholesterol levels . Having metabolic syndrome doubles the risk of developing cardiovascular diseases and type 2 diabetes mellitus. The prevalence of Metabolic Syndrome (MetS) is globally increasing due to the widespread adoption of the Western lifestyle . Between 2011 and 2018, the prevalence of Metabolic Syndrome (MetS) in the USA significantly increased from 37.6% in 2011-2012 to 41.8% in 2017-2018. This trend may be indicative of the rising epidemic of type 2 diabetes there . In Egypt, an estimated 10.9 million people currently have diabetes. This number is projected to rise to 13 million by 2030 and to 20 million by 2045.our aim to compare effect of Intermittent Islamic fasting with lifestyle modification versus lifestyle modification only on weight management, blood pressure, blood glucose and lipid profile among a group of metabolic syndrome patients.

A Randomized control open label trial was conducted on with metabolic syndrome, their ages range from (30- 45 years) attending the clinical nutrition outpatient clinic in the Zagazig University hospital from 1st of August (2023) to the end of February (2024) using consort guidelines and flow chart were used in this study including 54 patients with metabolic syndrome. At first, a Sample was picked by systematic random technique from patients attending clinical nutrition outpatient clinic of Zagazig University hospital then by block randomization, according to sex and BMI, the sample was classified randomly according to intervention type by block randomization using sealed Envelope website into 6 blocks each block size 9 list length with allocation ratio 1:1, Study was open -label . The sample was divided into two groups (intervention group and control group).

1. Group I: intervention group (27 patients) followed Islamic fasting with lifestyle modification; (Islamic fasting means: fasting two days per week (Monday and Thursday) with fasting (13, 14, 15) middle of lunar months).

2. Group II: control group (27 patients) followed lifestyle modification only.

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2023-12-14
• Study Completion: 2024-02-28
• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Adults with metabolic syndrome
• Adults (30-45years old)
• providing a consent.

Exclusion Criteria

• Had any chronic diseases
• pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Body weight	6 months	Pre and Post measurements of body weight in kilograms
Change in waist circumference	6 months	Pre and Post measurements of waist circumference in centimeters
Changes in Body mass index	6 months	Pre and Post measurements of Body mass index in kg/m\^2
Changes in blood pressure	6 months	Periodic measurements in systolic and diastolic blood pressure in mmHg

Secondary Outcome Measures

Name	Time	Method
Lipid profile Assessment	6 months	pre and post intervention measurements of serum Triglycerides, cholesterol, High density lipoprotein and Low density lipoprotein levels
Fasting blood glucose level	6 months	Pre and post intervention measurements of fasting blood glucose level

Trial Locations

Locations (1)

Zagazig University outpatients clinics; 🇪🇬 Zagazig, Sharkia, Egypt