Therapeutic Effects of Pomegranate Seed Powder on Metabolic Syndrome Markers
Phase: NA
Conditions: Metabolic Syndrome
Sponsor: Asif Ali

 
 
Title: 
Effect of Pomegranate Seed Powder on  
markers of Metabolic Syndrome  
NCT: 
Not Assigned yet 
Submission Date: 
Uploaded here on 21st June, 2023 
 

 
STATEMENT OF PROBLEM 
 
A number of chronic disorders can lead to metabolic syndrome, which has been identified 
as one of the key risk factors for the epidemic of type 2 diabetes and cardiovascular diseases in 
the twenty-first century. Thus, it’s a high time to mitigate the prevalence of these risk factors to 
overcome metabolic syndrome.  
Objective: 
To evaluate the effectiveness of pomegranate seed powder supplementation in preventing 
metabolic dysfunction and its main risk factors, such as hypertension and cardiovascular 
illnesses. 
 
  
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
Type of Study 
This trail is prospective clinical type.  
Supplement preparation  
Pomegranate seeds and arils will be separated, and then the seeds will be dried for 15 days in a 
lab environment. Later, a mechanical grinder will be used to powder the dried seeds. PS powder 
(PSP) will be packed in a capsule form, 5 g in each.  
Participants 
The population under study will be consisted of people suffering with any of the three metabolic 
impairments; Insulin resistance, obesity, disturbed glucose level, hyper-cholesterol, hypertension 
and higher blood pressure. Exclusion criteria will be critically ill or hospitalized patients and 
individuals with digestion and absorption issues.  
Span of study  
The clinical trial on the 50 patients of metabolic syndrome will be conducted for the duration of 
8 weeks with the supplementation of PSP capsule, twice a day. 
Outcome Evaluation 
Blood pressure, total cholesterol, and triglycerides (TG) will be measured at the enrollment point 
(i.e., baseline) and at the end of the 8-week intervention period. Fasting blood glucose (FBG), 
glycated haemoglobin (HbA1c), and triglycerides (TG) will be measured at the enrollment point 
(i.e., baseline). A fresh blood sample from a vein will then be taken and examined. A calibrated 
digital weight scale will also be used to check the patient's weight. Detail of all data collected is 
as follows: 

Anthropometric Measurements: 
 Weight 
 Height 
 Skin fold Thickness 
 
Biochemical Evaluation: 
 Blood Pressure 
 Fasting Blood Glucose 
 Total Cholesterol 
 Triglycerides 
 
Clinical Evaluation: 
 Obesity 
 
Statistical Analysis Plan 
Using one-way ANOVA, the statistical significance of the host parameter data will be 
determined (SPSS Inc., Chicago, IL, USA). When the p-values are less than 0.05, differences are 
considered significant. Statistical analyses will be carried out in the R programming environment 
for data sequencing. For both quantitative and qualitative variables, data will be displayed as 
means ± SD or frequency (percent), respectively.