Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anemia
  • Dyslipidemias
  • Hemoglobin SC
  • Hyperglycemia
  • Liver Dysfunction
  • Oxidative Stress
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A total of 60 subjects (30 in each group) will be included in the study. The total duration of study will be upto 6 months. The AKU faculty and staff will be invited to MDL lab for screening and initial baseline, enrolled participant will be informed for inclusion in the research on the basis of our criteria of HDL levels. Written informed consent (a copy will also be provided to the participant) will be taken from each individual. A questionnaire regarding their diet and life style will be filled. Following vitals will be measured body weight, height and blood pressure. Blood sample will be taken for lipid profile (LDL, HDL, total cholesterol and triglycerides). Total period for each participant will be 6 weeks for interventions. In Ajwa Dates group, number of interaction will be 5 days a week for 6 weeks (30 doses will be provided).Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

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...

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. Therefore, the focus of research now days had been toward the use of functional food which can play significant role in cardiac protection. Ajwa dates have been recognized to contain the nutritional and medicinal properties. These are a rich source of nutrition, containing sugars, proteins, vitamins, high dietary fibres, minerals and fats, various phytochemicals like sterols, polyphenols, flavonoids and glycosides. Ajwa fruit is gifted by nature and is enriched with polyphenols and can act as a protective agent against many diseases. Various studies have been conducted to investigate the presence of different polyphenols in Ajwa. Different researchers have determined different phenolic components

Tracking Information

NCT #
NCT03805139
Collaborators
Not Provided
Investigators
Not Provided