Role of Ajwa Derived Polyphenols in Dyslipidaemias

NCT03805139 | Unknown

• 1 other identifier: 122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias; Hyperglycemia; Liver Dysfunction; Oxidative Stress; Hemoglobin SC; Anemia

Keywords

Ajwa (Pheonix Dactylfera) Derived polyphenol; Dyslipidemia; Cardioprotection; HDL; Transferulic Acid; Gallic Acid

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Ajwa Dates group

EXPERIMENTAL

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

Dietary Supplement: Ajwa Date (phoenix dactylifera)

Control

NO INTERVENTION

No intervention

Interventions

Ajwa Date (phoenix dactylifera) DIETARY_SUPPLEMENT

Effect of Ajwa on Dyslipidemia

Ajwa Dates group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Dyslipidemias; Hyperglycemia; Liver Diseases; Hemoglobin SC Disease; Anemia

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Digestive System Diseases; Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: March 20, 2019
• Primary Completion: November 7, 2019
• Study Completion: December 7, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

PA (1)