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

Jordan University of Science and Technology

Status: Completed

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

Treatments: Other: Fresh pomegranate juice

Study type: Interventional

Funder types: Other

Identifiers

NCT03902288

IRB-20120189

Details and patient eligibility

About

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).

Enrollment: 85 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Patients with type 2 diabetes

Experimental group

Description:

Patients with type 2 diabetes at early stages of type 2 diabetes (FSG: 7.1 15.8 mmol/L)

Treatment:

Other: Fresh pomegranate juice

Healthy individuals

Active Comparator group

Description:

Healthy individuals match age and gender to the experimental group

Treatment:

Other: Fresh pomegranate juice