Fasting, IntermittentNCT06666894
Intermittent Fasting Versus Diet to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
A study testing Intermittent fasting and Dietary approach to stop hypertension (DASH) in people with Fasting, Intermittent and Diet, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Fasting, Intermittent, Diet, Hypertension
- What is being tested?
- Intermittent fasting and Dietary approach to stop hypertension (DASH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jun 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
- BMI >30
- All patients are sedentary lifestyle with little or no exercise.
- High lipid profile (total cholesterol > 200, LDL > 130, TAGs > 150) patients by laboratory investigation.
- High fasting insulin level > 20mlU/mL \& high fasting Glucose level >100, HbA1c > 5.7 \& high HOMA- IR > 2.5 patients by Laboratory investigation.
- High inflammatory markers (IL6) patients.
- Age ranged from 30 to 40 years old.
Who cannot join
- Alcoholic fatty liver patients.
- Cirrhosis patients.
- Diabetes patients.
- Cognitive impaired patients.
- History of epilepsy patients.
- Cardiac pacemaker patients.
- Anemic patients
- pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Giza
About this study
Official title: Intermittent Fasting Versus Dietary Approach to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.
Read the detailed description
Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.
- Conditions
- Fasting, Intermittent, Diet, Hypertension, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease
- Being tested
- Intermittent fasting, Dietary approach to stop hypertension (DASH)
- Medical subject headings
- Intermittent Fasting, Hypertension, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingOther
subjects consumed 100 % of their energy needs in an 8-h period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. The remaining 16 h per 24-h period made up the fasting period. Subjects in the ND group consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. all patients will be subjected to 30 minutes mild aerobic exercise on treadmill.
Dietary approach to stop hypertension (DASH)Other
The USDA's 2015-2020 Dietary Guidelines for Americans recommend a healthy eating pattern, including a variety of vegetables, fruits, whole grains, fat-free dairy, protein, and oils. Limit saturated fats, trans fats, added sugars, and sodium to less than 10% daily calories, 10% saturated fat daily calories, and 2,300 mg sodium per day.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting group | Experimental | intermittent fasting time-restricted feeding (TRF) subjects consumed 100 % of their energy needs in an 8 hours period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. schedule (8-hr daily eating period, The remaining 16 hours per 24-hour period made up the fasting period) Receives: Other: Intermittent fasting |
| Diet group | Active comparator | the dietary approach to stop hypertension (DASH) subjects consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. (12-hr eating period). Receives: Other: Dietary approach to stop hypertension (DASH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of Non-alcoholic fatty liver using ultrasonography
usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease
Measured: at baseline at after two months
Secondary outcomes (3)
assessment of change of lab profile using laboratory investigations
The study focuses on lipid profiles, glucose and insulin profiles, IL-6, and C- reactive protein. Blood samples are collected from the antecubital vein at baseline and after 8 weeks, and analyzed using the same reagent lot. Fasting total cholesterol, HDL-C, LDL-C, and triglycerides are measured using an enzymatic colorimetric method. LDL-C fraction is calculated using Friedewald's formula. Laboratory investigation before and after the study is conducted.
Measured: at baseline at after two months
assessment of change of body mass index
Anthropometric baseline characteristics of subjects by In Body 170 Pre \& post the study being performed (BMI)
Measured: at baseline at after two months
assessment of macronutrients distribution
- Dietary assessment for macronutrients distribution by dietary 24-hour recall Highlighted among dietary assessment methods of the current diet for their interest \& validity. It is a prospective, open ended survey method collecting data about the foods \& beverages consumed over a previously specified period of time.
Measured: at baseline at after two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting, IntermittentStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Khattab Omer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666894
- Sponsor's protocol ID
- Aya-005258
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting Versus Dietary Approach to Stop Hypertension on Metabolic Risk Profile in Nonalcoholic Fatty Liver Patients
- ClinicalTrials.gov ID
- NCT06666894
- Acronym / sponsor ID
- Aya-005258
- Conditions
- Fasting, Intermittent, Diet, Hypertension, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 31 Oct 2024 (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.
This study was conducted to compare between the effect of intermittent fasting and diatery approach to stop hypertension on metabolic risk profile in nonalcoholic fatty liver patients.
Detailed description
Non-alcoholic fatty liver is a liver disease linked to obesity, insulin resistance, type 2 diabetes, hypertension, hyperlipidemia, and metabolic syndrome. The subtype, non-alcoholic steatohepatitis, can lead to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver transplantation. The prevalence of Non-alcoholic fatty liver disease is increasing at the same rate as obesity, with the global prevalence estimated at 25%. By 2020, the burden of Non-alcoholic fatty liver is expected to exceed that of communicable disease in most regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting group | Experimental | Other: Intermittent fastingintermittent fasting time-restricted feeding (TRF) subjects consumed 100 % of their energy needs in an 8 hours period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. schedule (8-hr daily eating period, The remaining 16 hours per 24-hour period made up the fasting period) |
| Diet group | Active comparator | Other: Dietary approach to stop hypertension (DASH)the dietary approach to stop hypertension (DASH) subjects consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. (12-hr eating period). |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-alcoholic fatty liver patients diagnosed by radiological ultrasound
- BMI >30
- All patients are sedentary lifestyle with little or no exercise.
- High lipid profile (total cholesterol > 200, LDL > 130, TAGs > 150) patients by laboratory investigation.
- High fasting insulin level > 20mlU/mL \& high fasting Glucose level >100, HbA1c > 5.7 \& high HOMA- IR > 2.5 patients by Laboratory investigation.
Key exclusion criteria (8 listed)
- Alcoholic fatty liver patients.
- Cirrhosis patients.
- Diabetes patients.
- Cognitive impaired patients.
- History of epilepsy patients.
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 fastingsubjects consumed 100 % of their energy needs in an 8-h period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. The remaining 16 h per 24-h period made up the fasting period. Subjects in the ND group consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. all patients will be subjected to 30 minutes mild aerobic exercise on treadmill. | Other | Intermittent fasting group |
| Dietary approach to stop hypertension (DASH)The USDA's 2015-2020 Dietary Guidelines for Americans recommend a healthy eating pattern, including a variety of vegetables, fruits, whole grains, fat-free dairy, protein, and oils. Limit saturated fats, trans fats, added sugars, and sodium to less than 10% daily calories, 10% saturated fat daily calories, and 2,300 mg sodium per day. | Other | Diet group |
Primary outcome
assessment of Non-alcoholic fatty liver using ultrasonography
Time frame: at baseline at after two months
usage of diagnostic ultrasound to diagnose patients with non-alcoholic fatty liver disease
3 secondary outcomes
assessment of change of lab profile using laboratory investigations
Time frame: at baseline at after two months
assessment of change of body mass index
Time frame: at baseline at after two months
assessment of macronutrients distribution
Time frame: at baseline at after two 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 31 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 fasting and Dietary approach to stop hypertension (DASH) in people with Fasting, Intermittent and Diet, run by Cairo 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 7 inclusion and 8 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 31 Oct 2024. 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. 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?
assessment of Non-alcoholic fatty liver using ultrasonography (time frame: at baseline at after two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2024.