Short-term Effect of Pomegranate Juice on Blood Sugar and Its Controlling Hormones in Pre-diabetic and Type II Diabetic Patients.

Study Overview
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Brief Summary
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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).

Official Title
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Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes

Conditions
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Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)

Intervention / Treatment
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* Other: Fresh pomegranate juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with type 2 diabetes<br>Patients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L) | Other: Fresh pomegranate juice<br>* 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.<br>|
| Active Comparator: Healthy individuals<br>Healthy individuals match age and gender to the experimental group | Other: Fresh pomegranate juice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 - 3 hours | 
| Insulin hormone measurement | Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | 
| Erythropoietin hormone measurement | Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | 
| Thyroxine hormone measurement | Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | 
| Cortisol hormone measurement | Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion | 1 -3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melatonin hormone measurement | Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | 
| Testosterone hormone measurement | Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion | 1 - 3 hours | 
| Aldosterone hormone measurement | Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion | 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 | 1 - 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with type 2 diabetes, Fresh pomegranate juice, Fasting serum glucose