Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)NCT03902288
Short-term Effect of Pomegranate Juice on Blood Sugar and Its Controlling Hormones in Pre-diabetic and Type II Diabetic Patients.
A study testing Fresh pomegranate juice in people with Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L), run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Fresh pomegranate juice at 1.5 mL/kg of body weight was administered by recruited healthy individuals and patients with type 2 diabetes of fasting serum glucose between 7.1 and 15.8 mmol/L after approximately 12 hours fasting. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)
- What is being tested?
- Fresh pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2012to Apr 2013
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with type 2 diabetes at early stages of progression (Fasting serum glucose: 7.1 - 15.8 mmol/L)
- Healthy individuals (Fasting serum glucose < 7 mmol/L)
Who cannot join
- Subjects with renal
- Subjects with hepatic disease
- Pregnant women
- Subjects under treatment with insulin and any other hormonal therapies
- Smoking 12 hours before the intervention
- Antioxidant supplements 12 hours before the intervention
- Drugs administration: Lipid lowering drugs, oral hypoglycemic agents such as metformin or sulfonylureas 12 hours before the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
Fresh pomegranate juice at 1.5 mL/kg of body weight was administered by recruited healthy individuals and patients with type 2 diabetes of fasting serum glucose between 7.1 and 15.8 mmol/L after approximately 12 hours fasting. Blood samples were collected in plain tubes before (-5 minutes) and at 1 and 3 hours after drinking pomegranate juice. Blood samples were centrifuged and serum was collected and stored for glucose and hormonal analysis. Patients were recruited from those of earlier stages of type 2 diabetes, and many of them already drink pomegranate juice as of its benefits for their health).
The exclusion criteria included subjects with renal or hepatic disease, pregnancy, treatment with insulin, and hormone therapies. Participants who had either smoked cigarettes or taken antioxidant supplements, lipid-lowering drugs, and oral hypoglycemic agents, such as metformin (glucophage) or sulfonylureas, within the preceding 12 hours were also excluded.
The study was explained to all of the recruited subjects by the clinical researchers, and written informed consent was obtained prior to enrollment. Approval for the study was provided by the IRB Committee at Jordan University of Science and Technology (Irbid, Jordan).
- Being tested
- Fresh pomegranate juice
- Keywords
- Patients with type 2 diabetes, Fresh pomegranate juice, Fasting serum glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh pomegranate juiceOther
Pomegranate seeds (arils) were separated by hand, and fresh pomegranate juice was prepared by squeezing the seeds using a fruit squeezing machine. Fresh pomegranate juice was given at 1.5 mL/kg of body weight for the fasted recruited patient with type 2 diabetes (FSG < 15.8 mmol/L). Blood was collected before and after 1 and 3 hours of ingesting the juice.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Patients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L) Receives: Other: Fresh pomegranate juice |
| Healthy individuals | Active comparator | Healthy individuals match age and gender to the experimental group Receives: Other: Fresh pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum glucose measurement
Measuring the alteration in fasting serum glucose in mmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Insulin hormone measurement
Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Erythropoietin hormone measurement
Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Thyroxine hormone measurement
Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Cortisol hormone measurement
Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 -3 hours
Secondary outcomes (4)
Melatonin hormone measurement
Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Testosterone hormone measurement
Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Aldosterone hormone measurement
Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Serum total antioxidant activity measurement
Measuring serum total antioxidant activity in Trolox equivalents before and at 1 and 3 hours following pomegranate juice ingestion
Measured: 1 - 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A Patient with type 2 diabetes ( \< 15.8 FSG) and healthy individual ingested fresh pomegranate at 1.5 mL per kg of body weight after approximately 12 hours fasting. Blood samples were collected before (- 5 min) and after 1 and 3 hours of ingesting pomegranate juice.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleem A. Banihani, Jordan University of Science and Technology
- Investigators
- Saleem A. Banihani, PHD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902288
- Sponsor's protocol ID
- IRB-20120189
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banihani SA, Shuaibu SM, Al-Husein BA, Makahleh SS. Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients with Type 2 Diabetes. Int J Food Sci. 2019 Apr 18;2019:1269341. doi: 10.1155/2019/1269341. eCollection 2019.
PubMed 31139640
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03902288
- Acronym / sponsor ID
- IRB-20120189
- Keywords
- Patients with type 2 diabetes, Fresh pomegranate juice, Fasting serum glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Apr 2019 (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.
Fresh pomegranate juice at 1.5 mL/kg of body weight was administered by recruited healthy individuals and patients with type 2 diabetes of fasting serum glucose between 7.1 and 15.8 mmol/L after approximately 12 hours fasting. Blood samples were collected in plain tubes before (-5 minutes) and at 1 and 3 hours after drinking pomegranate juice. Blood samples were centrifuged and serum was collected and stored for glucose and hormonal analysis. Patients were recruited from those of earlier stages of type 2 diabetes, and many of them already drink pomegranate juice as of its benefits for their health).
The exclusion criteria included subjects with renal or hepatic disease, pregnancy, treatment with insulin, and hormone therapies. Participants who had either smoked cigarettes or taken antioxidant supplements, lipid-lowering drugs, and oral hypoglycemic agents, such as metformin (glucophage) or sulfonylureas, within the preceding 12 hours were also excluded.
The study was explained to all of the recruited subjects by the clinical researchers, and written informed consent was obtained prior to enrollment. Approval for the study was provided by the IRB Committee at Jordan University of Science and Technology (Irbid, Jordan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Patient with type 2 diabetes ( < 15.8 FSG) and healthy individual ingested fresh pomegranate at 1.5 mL per kg of body weight after approximately 12 hours fasting. Blood samples were collected before (- 5 min) and after 1 and 3 hours of ingesting pomegranate juice.
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Other: Fresh pomegranate juicePatients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L) |
| Healthy individuals | Active comparator | Other: Fresh pomegranate juiceHealthy individuals match age and gender to the experimental group |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes at early stages of progression (Fasting serum glucose: 7.1 - 15.8 mmol/L)
- Healthy individuals (Fasting serum glucose < 7 mmol/L)
Key exclusion criteria (7 listed)
- Subjects with renal
- Subjects with hepatic disease
- Pregnant women
- Subjects under treatment with insulin and any other hormonal therapies
- Smoking 12 hours before the intervention
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 |
|---|---|---|
| Fresh pomegranate juicePomegranate seeds (arils) were separated by hand, and fresh pomegranate juice was prepared by squeezing the seeds using a fruit squeezing machine. Fresh pomegranate juice was given at 1.5 mL/kg of body weight for the fasted recruited patient with type 2 diabetes (FSG < 15.8 mmol/L). Blood was collected before and after 1 and 3 hours of ingesting the juice. | Other | Healthy individuals, Patients with type 2 diabetes |
Primary outcome
Fasting serum glucose measurement
Time frame: 1 - 3 hours
Measuring the alteration in fasting serum glucose in mmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Insulin hormone measurement
Time frame: 1 - 3 hours
Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Erythropoietin hormone measurement
Time frame: 1 - 3 hours
Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Thyroxine hormone measurement
Time frame: 1 - 3 hours
Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion
Cortisol hormone measurement
Time frame: 1 -3 hours
Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion
4 secondary outcomes
Melatonin hormone measurement
Time frame: 1 - 3 hours
Testosterone hormone measurement
Time frame: 1 - 3 hours
Aldosterone hormone measurement
Time frame: 1 - 3 hours
Serum total antioxidant activity measurement
Time frame: 1 - 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Derived from this study: PubMed 31139640Banihani SA, Shuaibu SM, Al-Husein BA, Makahleh SS. Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients with Type 2 Diabetes. Int J Food Sci. 2019 Apr 18;2019:1269341. doi: 10.1155/2019/1269341. eCollection 2019.
- Individual participant dataSharing planned: No
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.
Saleem A. Banihani, PHD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh pomegranate juice in people with Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L), run by Jordan University of Science and Technology at 1 site in Jordan.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 Apr 2019. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting serum glucose measurement (time frame: 1 - 3 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902288, which also lists 1 linked publication.
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 4 Apr 2019.