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Completed

NCT Number: NCT03902288

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

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).

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Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fresh pomegranate juice

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2019
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.