Intermittent FastingNCT03805776
Intermittent Fasting in Dyslipidemia
A study testing Fasting (diet restruction for specific period) in people with Intermittent Fasting and Dyslipidemias, run by Aga Khan University at 1 site in Pakistan.
Trial summary
World Health Organization report notifies of the escalating global burden of cardiovascular diseases (CVD), projecting that it will become the major worldwide cause of death and disability by 2020. The South Asian countries have the highest rates of CVD globally. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting, Dyslipidemias, HDL Cholesterol, Low Serum
- What is being tested?
- Fasting (diet restruction for specific period)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2019to 15 Sep 2019
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General population with serum HDL less than 40 mg/dl for men and women
- Adult ages 18- 80 years will be included in the study.
Who cannot join
- Individuals Patients already observing fasting regularly
- Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Javeria Farooq, D. Pharm, Masters, 02134860051 ext. 4493, javeria.farooq@aku.edu
About this study
Official title: Role of Intermittent Fasting in Improving High Density Lipoprotein Cholesterol
World Health Organization report notifies of the escalating global burden of cardiovascular diseases (CVD), projecting that it will become the major worldwide cause of death and disability by 2020. The South Asian countries have the highest rates of CVD globally. It is widely acknowledged that South Asians have 40-60% higher risk of CVD linked to mortality, compared with other populations. Multiple human population studies have established the concentration of high density lipoprotein (HDL) cholesterol as an independent, inverse predictor of the risk of having a cardiovascular event. Furthermore, HDLs have several well-documented functions with the potential to protect against cardiovascular disease. This study trial is designed to find out the role of intermittent fasting to improve the dyslipidemia and particularly increase the levels of HDL in general population. Investigators expect that the intermittent fasting will significantly enhance the level of HDL and reduce cardiovascular events in general population.
Read the detailed description
INTRODUCTION:
Overall lipid profile is important in cardiovascular diseases but particularly serum HDL levels have long been recognized as an independent inverse prognostic marker of CVD, when the Framigham study, in 1980s showed that HDL below 40-60mg/dl is of prognostic relevance. A rise of 1mg/dl in HDL levels is considered to reduce coronary artery disease (CAD) risk to 2-3%. Even patients with elevated total cholesterol (TC) and LDL, presenting a high HDL are seen to be protected from atherosclerosis. Multiple human population studies have shown the concentration of HDL cholesterol as an independent, inverse predictor of the risk of having a cardiovascular event. Additionally, HDL has several well-documented functions with the potential to protect against cardiovascular diseases. These include an ability to promote the efflux of cholesterol from macrophages in the artery wall, inhibit the oxidative modification of LDL, inhibit vascular inflammation, inhibit thrombosis, promote endothelial repair, promote angiogenesis, anti-oxidant, enhance endothelial function, improve diabetic control, and inhibit hematopoietic stem cell proliferation. HDL also exerts direct cardio protective effect, which are mediated with its interactions with the myocardium.
Various studies have emphasised the high incidence of CVD within the South Asian countries. The increased risk of cardiovascular events in South Asians at a younger age might be due to unknown factors affecting plaque rupture, the interaction between prothrombotic factors and atherosclerosis, or may be due to any undiscovered risk factors. Urbanisation and westernisation is characterised by a distinct increase in the intake of energy dense foods, a decrease in physical activity, and a heightened level of psychosocial stress, all of which promote the development of hyperglycaemia, hypertension, and dyslipidaemia. Most common dyslipidaemia in South Asians is low HDL-C and high triglycerides. High triglyceride and low HDL-C levels are metabolically interlinked. This metabolic phenotype is also associated with increased levels of small LDL particles despite relatively normal levels of LDL-C among South Asians. This clinical syndrome is accompanied by insulin resistance, a condition frequently referred to as atherogenic dyslipidemia, which is a common metabolic derangement among Asian. South Asians not only have lower HDL levels but also have a higher concentration of small, less-protective HDL particles. One proposed mechanism is presence of dysfunctional HDL particles. Another potential explanation for the apparent blunted cardioprotection of HDL in South Asians might be related to HDL particle size. Small particles might be less efficient in reverse cholesterol transport. In general, HDL particle size tends to be lower in patients with CHD and those with low HDL-C levels . Alarmingly, an estimated 60-80% of Pakistani population has been reported to have low HDL. There are a number of non-pharmacological and pharmacological recommendations for management of low HDL. Non-pharmacological (functional food) strategies are reported to increase HDL levels around 10-15% and which include regular exercise , body weight reduction in obese individuals , cessation of cigarette smoking in smokers and dietary modifications like decrease intake of saturated trans-fatty acids with increase intake of omega-3 polyunsaturated fatty acids . There are also a number of pharmacological agents being considered as therapeutic options but the tolerability and safety issues limit their use in addition to limited success in improving HDL. IF may be a dietary method to aid in the improvement of the lipid profile in healthy, obese and dyslipidemia men and women, reducing total cholesterol, LDL, triglycerides and increasing HDL levels. However, the majority of studies that analyze the IF impacts on the lipid profile and body weight loss are observational and lack detailed information about diet. Randomized clinical trials with larger sample size are needed to evaluate the IF effects mainly in population with dyslipidemia.
HYPOTHESIS:
Intermittent fasting is capable of improving dyslipidemia and particularly enhancement of serum, HDL which can increase the cardioprotection in high risk general population.
OBJECTIVES:
To evaluate the effect of intermittent fasting on cholesterol levels specifically on HDL.
DATA STORAGE AND MANAGEMENT:
Every participant will be given a code number, all data will be saved according to the code numbers. Privacy will be maintain of each and every participant. Records will be kept confidential and used only for scientific purposes by authorized personnel. The hard copies will be kept in locked cupboards and soft data will be managed in password protected computers. Data will be stored at institutional level for almost 15 years.
DISSEMINATION OF FINDINGS AND PUBLICATION PLAN:
Investigators expect that Ajwa and intermittent fasting will significantly improve HDL levels in order to enhance the cardiac protection. This research will help in promoting the significance of use of functional food and fasting to improve overall health. Investigators expect at least two publications from this study. The findings of the study will be presented in international conference and will be published in well reputed journal.
- Conditions
- Intermittent Fasting, Dyslipidemias, HDL Cholesterol, Low Serum, Hepatic Enzymes and Function Abnormalities, Anemia, Kidney Diseases
- Being tested
- Fasting (diet restruction for specific period)
- Keywords
- Intermittent fasting, Fasting, Cholesterol
- Medical subject headings
- Intermittent Fasting, Dyslipidemias, Hypoalphalipoproteinemias, Anemia, Kidney Diseases, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting (diet restruction for specific period)Other
12-14 hours fasting
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Will observe intermittent fasting Receives: Other: Fasting (diet restruction for specific period) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG
Measured: 6 weeks
weight loss
Change in body weight (kg), as measured by scale weight
Measured: 6 weeks
Blood pressure
Reduction in systolic and diastolic
Measured: 6 weeks
Secondary outcomes (5)
Fasting Glucose
Fasting glucose mg/dl
Measured: 6 weeks
Fasting Insulin
Fasting insulin (IU/L)
Measured: 6 weeks
Waist circumference Waist circumference (cm)
WC in cm
Measured: 6 weeks
Lipid profile HbA1c (%) Lipids
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Measured: 6 weeks
Waist circumference
Waist circumference (cm)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start20 Feb 2019
- Primary completion1 Jun 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NASEER AHMED, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805776
- Sponsor's protocol ID
- 123
- Status last verified
- Feb 2019
- First submitted
- 14 Jan 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Aksungar FB, Eren A, Ure S, Teskin O, Ates G: Effects of intermittent fasting on serum lipid levels, coagulation status and plasma homocysteine levels. Annals of nutrition & metabolism 2005, 49:77-82. 2. Ahmet I, Wan R, Mattson MP, Lakatta EG, Talan M: Cardioprotection by intermittent fasting in rats. Circulation 2005, 112:3115-3121. 3. Santos HO, Macedo RCO: Impact of intermittent fasting on the lipid profile: Assessment associated with diet and weight loss. Clinical nutrition ESPEN 2018, 24:14-21. 4. Adlouni A, Ghalim N, Saı̈le R, Hda N, Parra H-J, Benslimane A: Beneficial effect on serum apo AI, apo B and Lp AI levels of Ramadan fasting. Clinica Chimica Acta 1998, 271:179-189. 5. Hammouda O, Chtourou H, Aloui A, Chahed H, Kallel C, Miled A, Chamari K, Chaouachi A, Souissi N: Concomitant effects of Ramadan fasting and time-of-day on apolipoprotein AI, B, Lp-a and homocysteine responses during aerobic exercise in Tunisian soccer players. PloS one 2013, 8:e79873.
Ahmed N, Farooq J, Siddiqi HS, Meo SA, Kulsoom B, Laghari AH, Jamshed H, Pasha F. Impact of Intermittent Fasting on Lipid Profile-A Quasi-Randomized Clinical Trial. Front Nutr. 2021 Feb 1;7:596787. doi: 10.3389/fnut.2020.596787. eCollection 2020.
PubMed 33598473
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intermittent Fasting in Improving High Density Lipoprotein Cholesterol
- ClinicalTrials.gov ID
- NCT03805776
- Acronym / sponsor ID
- 123
- Conditions
- Intermittent Fasting, Dyslipidemias, HDL Cholesterol, Low Serum, Hepatic Enzymes and Function Abnormalities, Anemia, Kidney Diseases
- Keywords
- Intermittent fasting, Fasting, Cholesterol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 16 Jan 2019 (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.
World Health Organization report notifies of the escalating global burden of cardiovascular diseases (CVD), projecting that it will become the major worldwide cause of death and disability by 2020. The South Asian countries have the highest rates of CVD globally. It is widely acknowledged that South Asians have 40-60% higher risk of CVD linked to mortality, compared with other populations. Multiple human population studies have established the concentration of high density lipoprotein (HDL) cholesterol as an independent, inverse predictor of the risk of having a cardiovascular event. Furthermore, HDLs have several well-documented functions with the potential to protect against cardiovascular disease. This study trial is designed to find out the role of intermittent fasting to improve the dyslipidemia and particularly increase the levels of HDL in general population. Investigators expect that the intermittent fasting will significantly enhance the level of HDL and reduce cardiovascular events in general population.
Detailed description
INTRODUCTION:
Overall lipid profile is important in cardiovascular diseases but particularly serum HDL levels have long been recognized as an independent inverse prognostic marker of CVD, when the Framigham study, in 1980s showed that HDL below 40-60mg/dl is of prognostic relevance. A rise of 1mg/dl in HDL levels is considered to reduce coronary artery disease (CAD) risk to 2-3%. Even patients with elevated total cholesterol (TC) and LDL, presenting a high HDL are seen to be protected from atherosclerosis. Multiple human population studies have shown the concentration of HDL cholesterol as an independent, inverse predictor of the risk of having a cardiovascular event. Additionally, HDL has several well-documented functions with the potential to protect against cardiovascular diseases. These include an ability to promote the efflux of cholesterol from macrophages in the artery wall, inhibit the oxidative modification of LDL, inhibit vascular inflammation, inhibit thrombosis, promote endothelial repair, promote angiogenesis, anti-oxidant, enhance endothelial function, improve diabetic control, and inhibit hematopoietic stem cell proliferation. HDL also exerts direct cardio protective effect, which are mediated with its interactions with the myocardium.
Various studies have emphasised the high incidence of CVD within the South Asian countries. The increased risk of cardiovascular events in South Asians at a younger age might be due to unknown factors affecting plaque rupture, the interaction between prothrombotic factors and atherosclerosis, or may be due to any undiscovered risk factors. Urbanisation and westernisation is characterised by a distinct increase in the intake of energy dense foods, a decrease in physical activity, and a heightened level of psychosocial stress, all of which promote the development of hyperglycaemia, hypertension, and dyslipidaemia. Most common dyslipidaemia in South Asians is low HDL-C and high triglycerides. High triglyceride and low HDL-C levels are metabolically interlinked. This metabolic phenotype is also associated with increased levels of small LDL particles despite relatively normal levels of LDL-C among South Asians. This clinical syndrome is accompanied by insulin resistance, a condition frequently referred to as atherogenic dyslipidemia, which is a common metabolic derangement among Asian. South Asians not only have lower HDL levels but also have a higher concentration of small, less-protective HDL particles. One proposed mechanism is presence of dysfunctional HDL particles. Another potential explanation for the apparent blunted cardioprotection of HDL in South Asians might be related to HDL particle size. Small particles might be less efficient in reverse cholesterol transport. In general, HDL particle size tends to be lower in patients with CHD and those with low HDL-C levels . Alarmingly, an estimated 60-80% of Pakistani population has been reported to have low HDL. There are a number of non-pharmacological and pharmacological recommendations for management of low HDL. Non-pharmacological (functional food) strategies are reported to increase HDL levels around 10-15% and which include regular exercise , body weight reduction in obese individuals , cessation of cigarette smoking in smokers and dietary modifications like decrease intake of saturated trans-fatty acids with increase intake of omega-3 polyunsaturated fatty acids . There are also a number of pharmacological agents being considered as therapeutic options but the tolerability and safety issues limit their use in addition to limited success in improving HDL. IF may be a dietary method to aid in the improvement of the lipid profile in healthy, obese and dyslipidemia men and women, reducing total cholesterol, LDL, triglycerides and increasing HDL levels. However, the majority of studies that analyze the IF impacts on the lipid profile and body weight loss are observational and lack detailed information about diet. Randomized clinical trials with larger sample size are needed to evaluate the IF effects mainly in population with dyslipidemia.
HYPOTHESIS:
Intermittent fasting is capable of improving dyslipidemia and particularly enhancement of serum, HDL which can increase the cardioprotection in high risk general population.
OBJECTIVES:
To evaluate the effect of intermittent fasting on cholesterol levels specifically on HDL.
DATA STORAGE AND MANAGEMENT:
Every participant will be given a code number, all data will be saved according to the code numbers. Privacy will be maintain of each and every participant. Records will be kept confidential and used only for scientific purposes by authorized personnel. The hard copies will be kept in locked cupboards and soft data will be managed in password protected computers. Data will be stored at institutional level for almost 15 years.
DISSEMINATION OF FINDINGS AND PUBLICATION PLAN:
Investigators expect that Ajwa and intermittent fasting will significantly improve HDL levels in order to enhance the cardiac protection. This research will help in promoting the significance of use of functional food and fasting to improve overall health. Investigators expect at least two publications from this study. The findings of the study will be presented in international conference and will be published in well reputed journal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Fasting (diet restruction for specific period)Will observe intermittent fasting |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- General population with serum HDL less than 40 mg/dl for men and women
- Adult ages 18- 80 years will be included in the study.
Key exclusion criteria (2 listed)
- Individuals Patients already observing fasting regularly
- Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded.
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 |
|---|---|---|
| Fasting (diet restruction for specific period)12-14 hours fasting | Other | Interventional |
Primary outcome
Lipid profile
Time frame: 6 weeks
Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG
weight loss
Time frame: 6 weeks
Change in body weight (kg), as measured by scale weight
Blood pressure
Time frame: 6 weeks
Reduction in systolic and diastolic
5 secondary outcomes
Fasting Glucose
Time frame: 6 weeks
Fasting Insulin
Time frame: 6 weeks
Waist circumference Waist circumference (cm)
Time frame: 6 weeks
Lipid profile HbA1c (%) Lipids
Time frame: 6 weeks
Waist circumference
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Background1. Aksungar FB, Eren A, Ure S, Teskin O, Ates G: Effects of intermittent fasting on serum lipid levels, coagulation status and plasma homocysteine levels. Annals of nutrition & metabolism 2005, 49:77-82. 2. Ahmet I, Wan R, Mattson MP, Lakatta EG, Talan M: Cardioprotection by intermittent fasting in rats. Circulation 2005, 112:3115-3121. 3. Santos HO, Macedo RCO: Impact of intermittent fasting on the lipid profile: Assessment associated with diet and weight loss. Clinical nutrition ESPEN 2018, 24:14-21. 4. Adlouni A, Ghalim N, Saı̈le R, Hda N, Parra H-J, Benslimane A: Beneficial effect on serum apo AI, apo B and Lp AI levels of Ramadan fasting. Clinica Chimica Acta 1998, 271:179-189. 5. Hammouda O, Chtourou H, Aloui A, Chahed H, Kallel C, Miled A, Chamari K, Chaouachi A, Souissi N: Concomitant effects of Ramadan fasting and time-of-day on apolipoprotein AI, B, Lp-a and homocysteine responses during aerobic exercise in Tunisian soccer players. PloS one 2013, 8:e79873.
- Derived from this study: PubMed 33598473Ahmed N, Farooq J, Siddiqi HS, Meo SA, Kulsoom B, Laghari AH, Jamshed H, Pasha F. Impact of Intermittent Fasting on Lipid Profile-A Quasi-Randomized Clinical Trial. Front Nutr. 2021 Feb 1;7:596787. doi: 10.3389/fnut.2020.596787. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting (diet restruction for specific period) in people with Intermittent Fasting and Dyslipidemias, run by Aga Khan University at 1 site in Pakistan.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 6 weeks). The study lists 3 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 NCT03805776, which also lists 2 linked publications.
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 21 Feb 2019.