Clinical trial NCT05944029: 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
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Hypertension
Obesity
Insulin Resistance
Diabetes
Pomegranate seed powder
Dyslipidemia
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Clinical Trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Lipid Profile
timeFrame: 7 weeks
measure: Fasting Glucose
timeFrame: 7 weeks
measure: Blood Pressure
timeFrame: 7 weeks
measure: Weight
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Veterinary and Animal sciences Lahore
state: Punjab
Study officials:
affiliation: University of Veterinary and Animal Sciences Lahore
name: Dr. Asif Ali, Mphil
role: STUDY_DIRECTOR
References: