Role of Ajwa Derived Polyphenols in Dyslipidaemias

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 alternative medicine such as functional food to improve the dyslipidemia and particularly increase the levels of HDL in general population. We expect that the use of Ajwa dates will significantly enhance the level of HDL and reduce cardiovascular events in general population.

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia; Anemia; Dyslipidemias; Oxidative Stress; Liver Dysfunction; Hemoglobin SC
• Intervention / Treatment: Dietary supplement: Ajwa Date (phoenix dactylifera)

Detailed 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 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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Recruiting
      • Aga Khan University
      • Contact: NASEER AHMED; Phone Number: 3333382013; Email: dr.naseer99@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• General population from AKU with serum HDL < 40 mg/dl for men and women
• Adult ages (18- 70years ) will be included in the study.

EXCLUSION CRITERIA:

• Individuals with Dates/Ajwa allergy
• Individuals Patients already taking regular Ajwa
• Pregnant women and individuals with diabetes, metabolic syndrome or any other co-morbidity will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Ajwa Dates group; 55-65gms Ajwa dates 7 days a week for 6 weeks	Dietary supplement: Ajwa Date (phoenix dactylifera); Effect of Ajwa on Dyslipidemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	Increase in HDL 3mg/dl, decrease LDL, TG, TC reduction in LDL, Triglycerides, total cholesterol 5mg/dl	6 weeks
Lipid profile	reduction in LDL	6 weeks
Lipid profile	reduction in triglycerides	6 weeks
Lipid profile	reduction in Total cholesterol	6 weeks
Lipid profile	Increase in HDL 3mg/dl reduction in LDL, Triglycerides, total cholesterol 5mg/dl	6 weeks
Lipid profile	reduced insulin resistance reduction in LDL, Triglycerides, total cholesterol 5mg/dl	6 weeks

Collaborators and Investigators

• Sponsor: Aga Khan University

Publications and helpful links

General Publications

• 1.Rocha-Guzmán NE, Herzog A, González-Laredo RF, Ibarra-Pérez FJ, Zambrano-Galván G, Gallegos-Infante JA: Antioxidant and antimutagenic activity of phenolic compounds in three different colour groups of common bean cultivars (Phaseolus vulgaris). Food Chemistry 2007, 103:521-527. 2. Majewska-Wierzbicka M, Czeczot H: [Flavonoids in the prevention and treatment of cardiovascular diseases]. Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego 2012, 32:50-54. 3. Salvamani S, Gunasekaran B, Shaharuddin NA, Ahmad SA, Shukor MY: Antiartherosclerotic effects of plant flavonoids. BioMed research international 2014, 2014:480258. 4. Norata GD, Marchesi P, Passamonti S, Pirillo A, Violi F, Catapano AL: Anti-inflammatory and anti-atherogenic effects of cathechin, caffeic acid and trans-resveratrol in apolipoprotein E deficient mice. Atherosclerosis 2007, 191:265-271. 5. Riccioni G, Gammone MA, Tettamanti G, Bergante S, Pluchinotta FR, D'Orazio N: Resveratrol and anti-atherogenic effects. International journal of food sciences and nutrition 2015, 66:603-610.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): November 7, 2019
• Study Completion (Anticipated): December 7, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Dyslipidemia; Cardioprotection; HDL; Ajwa (Pheonix Dactylfera) Derived polyphenol; Transferulic Acid; Gallic Acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Lipid Metabolism Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Liver Diseases; Hyperglycemia; Dyslipidemias; Hemoglobin SC Disease
• Other Study ID Numbers: 122 (Council for Stem Cell Sciences and Technologies)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No