Intermittent Fasting in Dyslipidemia

Sponsor

Aga Khan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03805776

Collaborator

(none)

Enrollment

Location

Arms

6.8

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Fasting Dyslipidemias HDL Cholesterol, Low Serum Hepatic Enzymes and Function Abnormalities Anemia Kidney Diseases Cardiac Function	Other: Fasting (diet restruction for specific period)	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Role of Intermittent Fasting in Improving High Density Lipoprotein Cholesterol

Actual Study Start Date :

Feb 20, 2019

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Sep 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional Will observe intermittent fasting	Other: Fasting (diet restruction for specific period) 12-14 hours fasting
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Interventional

Will observe intermittent fasting

Other: Fasting (diet restruction for specific period)

12-14 hours fasting

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Lipid profile [6 weeks]
Change in HDL more than 3mg/dl Change in LDL more than 3mg/dl Cholesterol and TG
weight loss [6 weeks]
Change in body weight (kg), as measured by scale weight
Blood pressure [6 weeks]
Reduction in systolic and diastolic

Secondary Outcome Measures

Fasting Glucose [6 weeks]
Fasting glucose mg/dl
Fasting Insulin [6 weeks]
Fasting insulin (IU/L)
Waist circumference Waist circumference (cm) [6 weeks]
WC in cm
Lipid profile HbA1c (%) Lipids [6 weeks]
Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
Waist circumference [6 weeks]
Waist circumference (cm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

Individuals Patients already observing fasting regularly
Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded.