Metabolic SyndromeNCT05944029
Effect of Pomegranate Seed Powder on Markers of Metabolic Syndrome
A study testing Pomegranate seed powder in people with Metabolic Syndrome, run by Asif Ali at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pomegranate seed powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2023to 24 Aug 2023
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI > 25kg/m2
- Dyslipidemia
- Altered blood glucose level
- Age 30-55 ( male and female)
Who cannot join
- Thyroid disorder
- Liver disease
- Kidney disorder
- Cancer etc
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
University of Veterinary and Animal sciences Lahore
Lahore, Punjab Province, 54000
Dr. Asif Ali, PhD, 03017151530 ext. 296, asif.ali@uvas.edu.pk
About this study
Official title: Therapeutic Effects of Pomegranate Seed Powder on Metabolic Syndrome Markers
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Pomegranate seed powder
- Keywords
- Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes, Pomegranate seed powder, Dyslipidemia
- Medical subject headings
- Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate seed powderDietary supplement
Also called Punica granatum
10 g powder / day
| Study group | Role | What they receive |
|---|---|---|
| Metabolic syndrome Patients | Experimental | Pomegranate seed powder is administered for alleviating symptoms of metabolic syndrome Receives: Dietary Supplement: Pomegranate seed powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile
The change in Lipid Profile, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Measured: 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.
Measured: 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.
Measured: 7 weeks
Weight
The change in weight, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start20 Feb 2023
- Primary completion20 Jul 2023 (estimated)
- Study completion24 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Clinical Trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asif Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asif Ali, University of Veterinary and Animal Sciences, Lahore - Pakistan
- Investigators
- Dr. Asif Ali, Mphil, Study director, University of Veterinary and Animal Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944029
- Sponsor's protocol ID
- UVAS
- Status last verified
- Jul 2023
- First submitted
- 11 Apr 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Intervention study, data will be confidential to maintain patients privacy, enrollment of patients with their consent
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Pomegranate Seed Powder on Metabolic Syndrome Markers
- ClinicalTrials.gov ID
- NCT05944029
- Acronym / sponsor ID
- UVAS
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Hypertension, Obesity, Insulin Resistance, Diabetes, Pomegranate seed powder, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asif AliUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 24 Aug 2023 (estimated)
- First posted
- 13 Jul 2023 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Metabolic syndrome Patients | Experimental | Dietary Supplement: Pomegranate seed powderPomegranate seed powder is administered for alleviating symptoms of metabolic syndrome |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI > 25kg/m2
- Dyslipidemia
- Altered blood glucose level
- Age 30-55 ( male and female)
Key exclusion criteria (4 listed)
- Thyroid disorder
- Liver disease
- Kidney disorder
- Cancer etc
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 |
|---|---|---|
| Pomegranate seed powderAlso: Punica granatum10 g powder / day | Dietary supplement | Metabolic syndrome Patients |
Primary outcome
Lipid Profile
Time frame: 7 weeks
The change in Lipid Profile, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Fasting Glucose
Time frame: 7 weeks
The change in Blood Glucose level, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Blood Pressure
Time frame: 7 weeks
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
Time frame: 7 weeks
The change in weight, after consuming Pomegranate seed powder for 7 weeks will be assessed, to look for improvements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No. Intervention study, data will be confidential to maintain patients privacy, enrollment of patients with their consent
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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.
Dr. Asif Ali, Mphil study director
University of Veterinary and Animal Sciences Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate seed powder in people with Metabolic Syndrome, run by Asif Ali 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 4 inclusion and 4 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 13 Jul 2023. 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?
Contact Shahbano Zahid, Mphil (+923095563643, shahbanozahid265@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Profile (time frame: 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.