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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Aga Khan University

    Karachi, Sindh, 74800

    Javeria Farooq, D. Pharm, Masters, 02134860051 ext. 4493, javeria.farooq@aku.edu

    Recruiting

Other trials in Pakistan

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.

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 groups in NCT03805776
Study groupRoleWhat they receive
InterventionalExperimentalWill observe intermittent fasting
Receives: Other: Fasting (diet restruction for specific period)
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipid profile

    Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG

    Measured: 6 weeks

  2. weight loss

    Change in body weight (kg), as measured by scale weight

    Measured: 6 weeks

  3. Blood pressure

    Reduction in systolic and diastolic

    Measured: 6 weeks

Secondary outcomes (5)
  1. Fasting Glucose

    Fasting glucose mg/dl

    Measured: 6 weeks

  2. Fasting Insulin

    Fasting insulin (IU/L)

    Measured: 6 weeks

  3. Waist circumference Waist circumference (cm)

    WC in cm

    Measured: 6 weeks

  4. Lipid profile HbA1c (%) Lipids

    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)

    Measured: 6 weeks

  5. 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.

  1. First posted16 Jan 2019
  2. Study start20 Feb 2019
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion15 Sep 2019 (estimated)

Resources

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)
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

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.

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