Intermittent Islamic Fasting in Metabolic SyndromeNCT06805526
Role of Intermittent Islamic Fasting in Management of Metabolic Syndrome
A study testing Intermittent Islamic fasting with lifestyle modification and Lifestyle modification only in people with Intermittent Islamic Fasting in Metabolic Syndrome, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Intermittent Islamic Fasting in Metabolic Syndrome
- What is being tested?
- Intermittent Islamic fasting with lifestyle modification and Lifestyle modification only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with metabolic syndrome
- Adults (30-45years old)
- providing a consent.
Who cannot join
- Had any chronic diseases
- pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University outpatients clinics
Zagazig, Sharqia Province, 44519
About this study
Official title: 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.
Read the 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).
- 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.
- Being tested
- Intermittent Islamic fasting with lifestyle modification, Lifestyle modification only
- Keywords
- Intermittent Islamic Fasting, lifestyle modification and Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Islamic fasting with lifestyle modificationBehavioural
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 onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | follow Islamic fasting with lifestyle modification Receives: Behavioral: Intermittent Islamic fasting with lifestyle modification |
| Control group | Sham comparator | follow lifestyle modification only Receives: Behavioral: Lifestyle modification only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body weight
Pre and Post measurements of body weight in kilograms
Measured: 6 months
Change in waist circumference
Pre and Post measurements of waist circumference in centimeters
Measured: 6 months
Changes in Body mass index
Pre and Post measurements of Body mass index in kg/m^2
Measured: 6 months
Changes in blood pressure
Periodic measurements in systolic and diastolic blood pressure in mmHg
Measured: 6 months
Secondary outcomes (2)
Lipid profile Assessment
pre and post intervention measurements of serum Triglycerides, cholesterol, High density lipoprotein and Low density lipoprotein levels
Measured: 6 months
Fasting blood glucose level
Pre and post intervention measurements of fasting blood glucose level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Aug 2023
- Primary completion14 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent Islamic Fasting in Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hanaa Abu Elazayem Ibrahim Nofal, Zagazig University
- Investigators
- Hanaa A Nofal, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805526
- Sponsor's protocol ID
- Intermittent Islamic fasting
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40670993
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intermittent Islamic Fasting Have Beneficial Effect in Management of Metabolic Syndrome? a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06805526
- Acronym / sponsor ID
- Intermittent Islamic fasting
- Keywords
- Intermittent Islamic Fasting, lifestyle modification and Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Intermittent Islamic fasting with lifestyle modificationfollow Islamic fasting with lifestyle modification |
| Control group | Sham comparator | Behavioral: Lifestyle modification onlyfollow lifestyle modification only |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults with metabolic syndrome
- Adults (30-45years old)
- providing a consent.
Key exclusion criteria (2 listed)
- Had any chronic diseases
- pregnant females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Islamic fasting with lifestyle modificationBoth 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 | Behavioural | Intervention group |
| Lifestyle modification onlyThe 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. | Behavioural | Control group |
Primary outcome
Changes in Body weight
Time frame: 6 months
Pre and Post measurements of body weight in kilograms
Change in waist circumference
Time frame: 6 months
Pre and Post measurements of waist circumference in centimeters
Changes in Body mass index
Time frame: 6 months
Pre and Post measurements of Body mass index in kg/m^2
Changes in blood pressure
Time frame: 6 months
Periodic measurements in systolic and diastolic blood pressure in mmHg
2 secondary outcomes
Lipid profile Assessment
Time frame: 6 months
Fasting blood glucose level
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 40670993Nofal 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanaa A Nofal, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Islamic fasting with lifestyle modification and Lifestyle modification only in people with Intermittent Islamic Fasting in Metabolic Syndrome, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body weight (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06805526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.