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Metabolic syndrome is a public health concern worldwide and in Pakistan as well. Abdominal obesity, hyperglycemia, hypertriglyceridemia, hypertension, and low HDL cholesterol are its hallmarks while pomegranate seed's unique chemical composition has sparked research into the health benefits in same arena as weight control, blood lipid profile changes, and other metabolic disturbances. It's high time to study therapeutic efficiency of Pomegranate seed powder against metabolic syndrome.
Metabolic syndrome, accumulation of certain metabolic risk factors, such as abdominal obesity, hyperglycemia, hypertriglyceridemia, hypertension, and low HDL cholesterol, has been noted as one of the most important risk factors for the epidemic of type 2 diabetes and cardiovascular disease in the 21st century. It has become a significant public health concern and a global epidemic with a prevalence rate of about 25% among American adults. Multiple researches have demonstrated the effectiveness of pomegranate in the management of diabetes, inflammatory conditions, obesity, and blood lipid levels, and consequently metabolic syndrome. Various pomegranate components have the potential to substitute anti-diabetic medications as well Pomegranate seed's unique chemical composition has sparked research into the health benefits, such as weight control, blood lipid profile changes, and other metabolic disorders.
seed powder can influence the patient's metabolic syndrome-related indicators.
Hypothesis:
Pomegranate seed powder can be effective to treat the individuals with impaired metabolism.
Methodology:
In a clinical trial, patients of metabolic syndrome (n=50) will be given pomegranate seed powder dose for over 8 weeks, twice a day. Biochemical outcomes including blood pressure, FBG, cholesterol, hemoglobin level will be determined before and after the completion of trial in addition to patient's weight. Finally, using one-way ANOVA and T-test, collected data will be analyzed.
Expected outcome: The study will explore the potential of pomegranate seed powder in treating metabolic syndrome's risk factors. Therefore, our findings on the studied parameters of patient will assist future researchers in developing tested, evidence-based recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic syndrome Patients | Experimental | Pomegranate seed powder is administered for alleviating symptoms of metabolic syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate seed powder | Dietary Supplement | 10 g powder / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipid Profile | The change in Lipid Profile, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements. | 7 weeks |
| Fasting Glucose | The change in Blood Glucose level, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements. | 7 weeks |
| Blood Pressure | The change in both systolic and diastolic blood pressure after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements. | 7 weeks |
| Weight | The change in weight, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements. | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahbano Zahid, Mphil | Contact | +923095563643 | shahbanozahid265@gmail.com | |
| Dr. Asif Ali, PhD | Contact | +923017151530 | 296 | asif.ali@uvas.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Asif Ali, Mphil | University of Veterinary and Animal Sciences Lahore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Veterinary and Animal sciences Lahore | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
Intervention study, data will be confidential to maintain patients privacy, enrollment of patients with their consent
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 21, 2023 | Jun 21, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective Clinical Trial
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |