search
Back to results

Role of Ajwa Derived Polyphenols in Dyslipidaemias

Primary Purpose

Dyslipidemias, Hyperglycemia, Liver Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Ajwa Date (phoenix dactylifera)
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias focused on measuring Ajwa (Pheonix Dactylfera) Derived polyphenol, Dyslipidemia, Cardioprotection, HDL, Transferulic Acid, Gallic Acid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aga Khan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ajwa Dates group

Control

Arm Description

55-65gms Ajwa dates 7 days a week for 6 weeks

No intervention

Outcomes

Primary Outcome Measures

Lipid profile
Increase in HDL 3mg/dl, decrease LDL, TG, TC reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Lipid profile
reduction in LDL
Lipid profile
reduction in triglycerides
Lipid profile
reduction in Total cholesterol
Lipid profile
Increase in HDL 3mg/dl reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Lipid profile
reduced insulin resistance reduction in LDL, Triglycerides, total cholesterol 5mg/dl

Secondary Outcome Measures

Full Information

First Posted
January 11, 2019
Last Updated
November 7, 2019
Sponsor
Aga Khan University
search

1. Study Identification

Unique Protocol Identification Number
NCT03805139
Brief Title
Role of Ajwa Derived Polyphenols in Dyslipidaemias
Official Title
Role of Ajwa Derived Polyphenols in Dyslipidaemias
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
December 7, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Hyperglycemia, Liver Dysfunction, Oxidative Stress, Hemoglobin SC, Anemia
Keywords
Ajwa (Pheonix Dactylfera) Derived polyphenol, Dyslipidemia, Cardioprotection, HDL, Transferulic Acid, Gallic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ajwa Dates group
Arm Type
Experimental
Arm Description
55-65gms Ajwa dates 7 days a week for 6 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Ajwa Date (phoenix dactylifera)
Intervention Description
Effect of Ajwa on Dyslipidemia
Primary Outcome Measure Information:
Title
Lipid profile
Description
Increase in HDL 3mg/dl, decrease LDL, TG, TC reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Time Frame
6 weeks
Title
Lipid profile
Description
reduction in LDL
Time Frame
6 weeks
Title
Lipid profile
Description
reduction in triglycerides
Time Frame
6 weeks
Title
Lipid profile
Description
reduction in Total cholesterol
Time Frame
6 weeks
Title
Lipid profile
Description
Increase in HDL 3mg/dl reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Time Frame
6 weeks
Title
Lipid profile
Description
reduced insulin resistance reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NASEER AHMED
Phone
3333382013
Email
dr.naseer99@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
background

Learn more about this trial

Role of Ajwa Derived Polyphenols in Dyslipidaemias

We'll reach out to this number within 24 hrs