Effect of Pomegranate Seed Powder on Markers of Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pomegranate seed powder
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes, Pomegranate seed powder, Dyslipidemia
Eligibility Criteria
Inclusion Criteria: BMI > 25kg/m2 Dyslipidemia Altered blood glucose level Age 30-55 ( male and female) Exclusion Criteria: Thyroid disorder Liver disease Kidney disorder Cancer etc
Sites / Locations
- University of Veterinary and Animal sciences LahoreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metabolic syndrome Patients
Arm Description
Pomegranate seed powder is administered for alleviating symptoms of metabolic syndrome
Outcomes
Primary Outcome Measures
Lipid Profile
The change in Lipid Profile, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Fasting Glucose
The change in Blood Glucose level, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
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.
Weight
The change in weight, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05944029
Brief Title
Effect of Pomegranate Seed Powder on Markers of Metabolic Syndrome
Official Title
Therapeutic Effects of Pomegranate Seed Powder on Metabolic Syndrome Markers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
August 24, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asif Ali
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
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes, Pomegranate seed powder, Dyslipidemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Clinical Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metabolic syndrome Patients
Arm Type
Experimental
Arm Description
Pomegranate seed powder is administered for alleviating symptoms of metabolic syndrome
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate seed powder
Other Intervention Name(s)
Punica granatum
Intervention Description
10 g powder / day
Primary Outcome Measure Information:
Title
Lipid Profile
Description
The change in Lipid Profile, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Time Frame
7 weeks
Title
Fasting Glucose
Description
The change in Blood Glucose level, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Time Frame
7 weeks
Title
Blood Pressure
Description
The change in both systolic and diastolic blood pressure after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Time Frame
7 weeks
Title
Weight
Description
The change in weight, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 25kg/m2
Dyslipidemia
Altered blood glucose level
Age 30-55 ( male and female)
Exclusion Criteria:
Thyroid disorder
Liver disease
Kidney disorder
Cancer etc
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahbano Zahid, Mphil
Phone
+923095563643
Email
shahbanozahid265@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Asif Ali, PhD
Phone
+923017151530
Ext
296
Email
asif.ali@uvas.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Asif Ali, Mphil
Organizational Affiliation
University of Veterinary and Animal Sciences Lahore
Official's Role
Study Director
Facility Information:
Facility Name
University of Veterinary and Animal sciences Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Asif Ali, PhD
Phone
03017151530
Ext
296
Email
asif.ali@uvas.edu.pk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Intervention study, data will be confidential to maintain patients privacy, enrollment of patients with their consent
Learn more about this trial
Effect of Pomegranate Seed Powder on Markers of Metabolic Syndrome
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