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NCT Number: NCT06805526

Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome

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.

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Key information

Conditions

Intermittent Islamic Fasting in Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University outpatients clinics

Zagazig, Sharqia Province, 44519, Egypt

About this study

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).

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Had any chronic diseases
  • pregnant females.

Treatment and study plan

Intermittent Islamic fasting with lifestyle modification

Behavioral

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

Lifestyle modification only

Behavioral

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.

Primary outcomes

  1. Changes in Body weight

    Time frame: 6 months

    Pre and Post measurements of body weight in kilograms

  2. Change in waist circumference

    Time frame: 6 months

    Pre and Post measurements of waist circumference in centimeters

  3. Changes in Body mass index

    Time frame: 6 months

    Pre and Post measurements of Body mass index in kg/m^2

  4. Changes in blood pressure

    Time frame: 6 months

    Periodic measurements in systolic and diastolic blood pressure in mmHg

Secondary outcomes

  1. Lipid profile Assessment

    Time frame: 6 months

    pre and post intervention measurements of serum Triglycerides, cholesterol, High density lipoprotein and Low density lipoprotein levels

  2. Fasting blood glucose level

    Time frame: 6 months

    Pre and post intervention measurements of fasting blood glucose level

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 3, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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