Clinical trial NCT06805526: Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome
Official title: Does Intermittent Islamic Fasting Have Beneficial Effect in Management of Metabolic Syndrome? a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Islamic Fasting in Metabolic Syndrome
Keywords: Intermittent Islamic Fasting, lifestyle modification and Metabolic Syndrome
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-02-03
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Had any chronic diseases
* pregnant females.

Primary outcomes:
measure: Changes in Body weight
timeFrame: 6 months
measure: Change in waist circumference
timeFrame: 6 months
measure: Changes in Body mass index
timeFrame: 6 months
measure: Changes in blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Lipid profile Assessment
timeFrame: 6 months
measure: Fasting blood glucose level
timeFrame: 6 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University outpatients clinics
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Hanaa A Nofal, MD
role: PRINCIPAL_INVESTIGATOR
References: