Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE October 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Melatonin hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion
  • Testosterone hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion
  • Aldosterone hormone measurement [ Time Frame: 1 - 3 hours ]
    Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Effect of Pomegranate Juice on Blood Sugar and Its Controlling Hormones in Pre-diabetic and Type II Diabetic Patients.
Official Title  ICMJE Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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)
    Intervention: Other: Fresh pomegranate juice
  • Active Comparator: Healthy individuals
    Healthy individuals match age and gender to the experimental group
    Intervention: Other: Fresh pomegranate juice
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
85
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03902288
Other Study ID Numbers  ICMJE IRB-20120189
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Saleem A. Banihani, Jordan University of Science and Technology
Study Sponsor  ICMJE Jordan University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saleem A. Banihani, PHD Jordan University of Science and Technology
PRS Account Jordan University of Science and Technology
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP