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CompletedNCT03902288Updated Apr 4, 2019

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

An interventional study of Fresh pomegranate juice in Patients With Type 2 Diabetes (FSG: More Than 7.1 and Not Higher Than 15.8 mmol/L), sponsored by Jordan University of Science and Technology. Completed at 1 site in Jordan. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 6 months after the study started (first participant enrolled Oct 2012, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study 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).

02

Conditions studied

  • 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
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 85 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Jordan University of Science and Technology is the lead sponsor of 88 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • 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)

    Other: Fresh pomegranate juice

  • Active comparator
    Healthy individuals

    Healthy individuals match age and gender to the experimental group

    Other: Fresh pomegranate juice

Interventions

  • OtherFresh 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.

06

What researchers measure

Primary outcomes

  1. Fasting serum glucose measurement

    Measuring the alteration in fasting serum glucose in mmol/L before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  2. Insulin hormone measurement

    Measuring insulin in μIU/mL before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  3. Erythropoietin hormone measurement

    Measuring erythropoietin in mIU/mL before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  4. Thyroxine hormone measurement

    Measuring erythropoietin in μg/dL before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  5. Cortisol hormone measurement

    Measuring erythropoietin in nmol/L before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 -3 hours

Secondary outcomes

  1. Melatonin hormone measurement

    Measuring Melatonin in pg/mL before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  2. Testosterone hormone measurement

    Measuring testosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  3. Aldosterone hormone measurement

    Measuring aldosterone in ng/dL before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

  4. Serum total antioxidant activity measurement

    Measuring serum total antioxidant activity in Trolox equivalents before and at 1 and 3 hours following pomegranate juice ingestion

    Time frame: 1 - 3 hours

07

Study locations

1 site
  • Jordan University of Science and Technology
    Irbid, 22110, Jordan
08

References and documents

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. PubMed 31139640 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03902288
Lead sponsor
Jordan University of Science and Technology
Responsible party
Saleem A. Banihani (Associate Professor Doctor, Jordan University of Science and Technology) — Principal investigator
First posted
Apr 4, 2019
Start date
Oct 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Apr 4, 2019

Study contacts

Saleem A. Banihani, PHD
principal investigator · Jordan University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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