Anemia Clinical Trial
Official title:
Role of Ajwa Derived Polyphenols in Dyslipidaemias
NCT number | NCT03805139 |
Other study ID # | 122 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 20, 2019 |
Est. completion date | December 7, 2019 |
Verified date | November 2019 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 7, 2019 |
Est. primary completion date | November 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan University | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University |
Pakistan,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lipid profile | Increase in HDL 3mg/dl, decrease LDL, TG, TC reduction in LDL, Triglycerides, total cholesterol 5mg/dl | 6 weeks | |
Primary | Lipid profile | reduction in LDL | 6 weeks | |
Primary | Lipid profile | reduction in triglycerides | 6 weeks | |
Primary | Lipid profile | reduction in Total cholesterol | 6 weeks | |
Primary | Lipid profile | Increase in HDL 3mg/dl reduction in LDL, Triglycerides, total cholesterol 5mg/dl | 6 weeks | |
Primary | Lipid profile | reduced insulin resistance reduction in LDL, Triglycerides, total cholesterol 5mg/dl | 6 weeks |
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