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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902288
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Saleem A. Banihani, Jordan University of Science and Technology

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L) Other: Fresh pomegranate juice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
Actual Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Patients with type 2 diabetes
Patients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L)
Other: Fresh pomegranate juice
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.

Active Comparator: Healthy individuals
Healthy individuals match age and gender to the experimental group
Other: Fresh pomegranate juice
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.




Primary Outcome Measures :
  1. 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

  2. Insulin hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion

  3. Erythropoietin hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion

  4. Thyroxine hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion

  5. Cortisol hormone measurement [ Time Frame: 1 -3 hours ]
    Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion


Secondary Outcome Measures :
  1. Melatonin hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion

  2. Testosterone hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion

  3. Aldosterone hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion

  4. Serum total antioxidant activity measurement [ Time Frame: 1 - 3 hours ]
    Measuring serum total antioxidant activity in Trolox equivalents before and at 1 and 3 hours following pomegranate juice ingestion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902288


Locations
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Jordan
Jordan University of Science and Technology
Irbid, Jordan, 22110
Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
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Principal Investigator: Saleem A. Banihani, PHD Jordan University of Science and Technology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Saleem A. Banihani, Associate Professor Doctor, Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03902288    
Other Study ID Numbers: IRB-20120189
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saleem A. Banihani, Jordan University of Science and Technology:
Patients with type 2 diabetes
Fresh pomegranate juice
Fasting serum glucose
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases