DyslipidemiasNCT03805139
Role of Ajwa Derived Polyphenols in Dyslipidaemias
A study testing Ajwa Date (phoenix dactylifera) in people with Dyslipidemias and Hyperglycemia, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hyperglycemia, Liver Dysfunction
- What is being tested?
- Ajwa Date (phoenix dactylifera)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2019to 7 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General population from AKU with serum HDL < 40 mg/dl for men and women
- Adult ages (18- 70years ) will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
NASEER AHMED, 3333382013, dr.naseer99@gmail.com
About this study
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.
Read the 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
- Conditions
- Dyslipidemias, Hyperglycemia, Liver Dysfunction, Oxidative Stress, Hemoglobin SC, Anemia
- Being tested
- Ajwa Date (phoenix dactylifera)
- Keywords
- Ajwa (Pheonix Dactylfera) Derived polyphenol, Dyslipidemia, Cardioprotection, HDL, Transferulic Acid, Gallic Acid
- Medical subject headings
- Dyslipidemias, Hyperglycemia, Liver Diseases, Hemoglobin SC Disease, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ajwa Date (phoenix dactylifera)Dietary supplement
Effect of Ajwa on Dyslipidemia
| Study group | Role | What they receive |
|---|---|---|
| Ajwa Dates group | Experimental | 55-65gms Ajwa dates 7 days a week for 6 weeks Receives: Dietary Supplement: Ajwa Date (phoenix dactylifera) |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Increase in HDL 3mg/dl, decrease LDL, TG, TC reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Measured: 6 weeks
Lipid profile
reduction in LDL
Measured: 6 weeks
Lipid profile
reduction in triglycerides
Measured: 6 weeks
Lipid profile
reduction in Total cholesterol
Measured: 6 weeks
Lipid profile
Increase in HDL 3mg/dl reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Measured: 6 weeks
Lipid profile
reduced insulin resistance reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start20 Mar 2019
- Primary completion7 Nov 2019
- Study completion7 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NASEER AHMED, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805139
- Sponsor's protocol ID
- 122
- Status last verified
- Nov 2019
- First submitted
- 11 Jan 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ajwa Derived Polyphenols in Dyslipidaemias
- ClinicalTrials.gov ID
- NCT03805139
- Acronym / sponsor ID
- 122
- Conditions
- Dyslipidemias, Hyperglycemia, Liver Dysfunction, Oxidative Stress, Hemoglobin SC, Anemia
- Keywords
- Ajwa (Pheonix Dactylfera) Derived polyphenol, Dyslipidemia, Cardioprotection, HDL, Transferulic Acid, Gallic Acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Dec 2019 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ajwa Dates group | Experimental | Dietary Supplement: Ajwa Date (phoenix dactylifera)55-65gms Ajwa dates 7 days a week for 6 weeks |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- General population from AKU with serum HDL < 40 mg/dl for men and women
- Adult ages (18- 70years ) will be included in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ajwa Date (phoenix dactylifera)Effect of Ajwa on Dyslipidemia | Dietary supplement | Ajwa Dates group |
Primary outcome
Lipid profile
Time frame: 6 weeks
Increase in HDL 3mg/dl, decrease LDL, TG, TC reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Lipid profile
Time frame: 6 weeks
reduction in LDL
Lipid profile
Time frame: 6 weeks
reduction in triglycerides
Lipid profile
Time frame: 6 weeks
reduction in Total cholesterol
Lipid profile
Time frame: 6 weeks
Increase in HDL 3mg/dl reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Lipid profile
Time frame: 6 weeks
reduced insulin resistance reduction in LDL, Triglycerides, total cholesterol 5mg/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Background1.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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ajwa Date (phoenix dactylifera) in people with Dyslipidemias and Hyperglycemia, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.