Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome

NCT ID: NCT06805526

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-02-28

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.

Conditions

Intermittent Islamic Fasting in Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

follow Islamic fasting with lifestyle modification

Group Type: ACTIVE_COMPARATOR

Intermittent Islamic fasting with lifestyle modification

Intervention Type: 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

Control group

follow lifestyle modification only

Group Type: SHAM_COMPARATOR

Lifestyle modification only

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Had any chronic diseases
• pregnant females.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hanaa Abu Elazayem Ibrahim Nofal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanaa A Nofal, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University outpatients clinics

Zagazig, Sharqia Province, Egypt

Countries

Egypt

References

Nofal HA, Elmor AAR, AbdAllah AM, Zaitoun NA, Andargeery SY, Sharafeddin MA, Hassan RIA, Elhawy LL. Effect of intermittent Islamic fasting in management of metabolic syndrome: a randomized control trial. BMC Public Health. 2025 Jul 16;25(1):2476. doi: 10.1186/s12889-025-23493-7.

Reference Type: DERIVED

PMID: 40670993 (View on PubMed)

Other Identifiers

Intermittent Islamic fasting

Identifier Type: -

Identifier Source: org_study_id