Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome

Does Intermittent Islamic Fasting Have Beneficial Effect in Management of Metabolic Syndrome? a Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Islamic Fasting in Metabolic Syndrome
• Intervention / Treatment: Behavioral: Intermittent Islamic fasting with lifestyle modification; Behavioral: Lifestyle modification only

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44519
      • Zagazig University outpatients clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Had any chronic diseases
• pregnant females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; follow Islamic fasting with lifestyle modification	Behavioral: Intermittent Islamic fasting with lifestyle modification; Both groups followed a healthy lifestyle for 6 months including: Diet: The participants' habitual total energy expenditure was estimated using the standard Harris-Benedict equation. To achieve a reduction of over 500 kcal/day, a daily intake of 1,200 to 1,500 kcal is typically recommended for women and 1,500 to 1,800 kcal for men . Physical Activity: Moderate physical activity is advised. This includes engaging in exercise for 30 to 60 minutes, five days a week. Additionally, incorporating resistance training is recommended twice a week .; stress management How to cope with stress, relaxation technique, quality and quantity of sleep,; Drinking enough water 30-40ml/kg/day. Followed Intermittent Islamic fasting which meant fasting two days per week (Monday and Thursday) with fasting (13, 14, 15) middle of lunar months. (during Intermittent Islamic fasting caloric requirement was distributed as 30-40 For Group I (intervention group) only, Followed Intermittent Islamic fasting wh
Sham Comparator: Control group; follow lifestyle modification only	Behavioral: Lifestyle modification only; The participants' habitual total energy expenditure was estimated using the standard Harris-Benedict equation. For men, the formula is: BMR = 66.4730 + 13.7516 × weight (kg) + 5.0033 × height (cm) - 6.7550 × age (years). For women, the formula is: BMR = 655.0955 + 9.5634 × weight (kg) + 1.8496 × height (cm) - 4.6756 × age (years) [27]. To achieve a reduction of over 500 kcal/day, a daily intake of 1,200 to 1,500 kcal is typically recommended for women and 1,500 to 1,800 kcal for men [28]. Physical Activity: Moderate physical activity is advised. This includes engaging in exercise for 30 to 60 minutes, five days a week. Additionally, incorporating resistance training is recommended twice a week [29].; stress management How to cope with stress, relaxation technique, quality and quantity of sleep,; Drinking enough water 30-40ml/kg/day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Hanaa A Nofal, MD, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 27, 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 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Intermittent Islamic Fasting, lifestyle modification and Metabolic Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: Intermittent Islamic fasting

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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