Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome

NCT06805526 | Completed

• 1 other identifier: Intermittent Islamic fasting
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Islamic Fasting in Metabolic Syndrome

Keywords

Intermittent Islamic Fasting, lifestyle modification and Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Lipid profile Assessment

  6 months

• Fasting blood glucose level

  6 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

follow Islamic fasting with lifestyle modification

Behavioral: Intermittent Islamic fasting with lifestyle modification

Control group

SHAM COMPARATOR

follow lifestyle modification only

Behavioral: Lifestyle modification only

Interventions

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

Intervention group

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.

Control group

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Had any chronic diseases
• pregnant females.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University outpatients clinics

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40670993 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hanaa A Nofal, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (open label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 3, 2025
• Study Start: August 1, 2023
• Primary Completion: December 14, 2023
• Study Completion: February 28, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)