Clinical trial NCT03902288: Short-term Effect of Pomegranate Juice on Blood Sugar and Its Controlling Hormones in Pre-diabetic and Type II Diabetic Patients.
Official title: Fresh Pomegranate Juice Decreases Fasting Serum Erythropoietin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L)
Keywords: Patients with type 2 diabetes
Fresh pomegranate juice
Fasting serum glucose
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 85
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Fasting serum glucose measurement
timeFrame: 1 - 3 hours
measure: Insulin hormone measurement
timeFrame: 1 - 3 hours
measure: Erythropoietin hormone measurement
timeFrame: 1 - 3 hours
measure: Thyroxine hormone measurement
timeFrame: 1 - 3 hours
measure: Cortisol hormone measurement
timeFrame: 1 -3 hours
Secondary outcomes:
measure: Melatonin hormone measurement
timeFrame: 1 - 3 hours
measure: Testosterone hormone measurement
timeFrame: 1 - 3 hours
measure: Aldosterone hormone measurement
timeFrame: 1 - 3 hours
measure: Serum total antioxidant activity measurement
timeFrame: 1 - 3 hours
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Saleem A. Banihani, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.