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

Not Applicable

Completed

• Conditions: Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)
• Interventions: Other: Fresh pomegranate juice

• Registration Number: NCT03902288
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2019-04
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-04
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy individuals	Fresh pomegranate juice	Healthy individuals match age and gender to the experimental group
Patients with type 2 diabetes	Fresh pomegranate juice	Patients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L)

Primary Outcome Measures

Name	Time	Method
Insulin hormone measurement	1 - 3 hours	Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Cortisol hormone measurement	1 -3 hours	Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Fasting serum glucose measurement	1 - 3 hours	Measuring the alteration in fasting serum glucose in mmol/L before and at 1 and 3 hours following pomegranate juice ingestion
Erythropoietin hormone measurement	1 - 3 hours	Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion
Thyroxine hormone measurement	1 - 3 hours	Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion

Secondary Outcome Measures

Name	Time	Method
Testosterone hormone measurement	1 - 3 hours	Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion
Serum total antioxidant activity measurement	1 - 3 hours	Measuring serum total antioxidant activity in Trolox equivalents before and at 1 and 3 hours following pomegranate juice ingestion
Melatonin hormone measurement	1 - 3 hours	Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion
Aldosterone hormone measurement	1 - 3 hours	Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan