Modulating Effects of Oil Palm Phenolics in Uncontrolled Insulin-treated Type 2 Diabetes Mellitus (UNIDOPP)

Study reported that providing Oil Palm Phenolics to Nile rats blocked diabetes progression in this spontaneous diabetes model. The present study aims to determine the beneficial effects of Oil Palm Phenolics in uncontrolled insulin treated type 2 diabetic patients.

Study Overview

• Status: Terminated
• Conditions: Uncontrolled Insulin-treated Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Oil Palm Phenolics

Detailed Description

Recent studies suggest the potential of polyphenols as a supplementary treatment for diabetes mellitus owing to their biological properties. Polyphenols are natural phytochemical compounds found in fruits and vegetables. The most common group of phenolic compounds in our diet are phenolic acids and flavonoids. The two main classes are hydroxybenzoic acid derivatives and hydroxycinnamic acid derivatives.

The potential efficacy of polyphenols on glucose homeostasis and carbohydrate metabolism is being aggressively investigated in in vitro, animal models and clinical trials. The anti-hyperglycemic property of polyphenols is mainly contributed by the reduction of dietary carbohydrate absorption through intestines, improvement of β-cell function and insulin action, stimulation of insulin secretion, modulation of the enzymes involved in glucose metabolism, anti-oxidative and anti-inflammatory effects.

The key enzymes responsible for the digestion of dietary carbohydrates to glucose are α-glucosidase and α-amylase. One of the most well-known properties of polyphenols especially phenolic acids on carbohydrate metabolism is the inhibition of these enzymes. Some investigations have shown that polyphenols are also able to regulate postprandial glycemia and inhibit the development of glucose intolerance by a facilitated insulin response and increased secretion of glucose-dependent insulinotropic polypeptide (GIP) and glucagonlike polypeptide-1 (GLP-1).

The current study focuses on the glucose-controlling properties of phenolic compounds extracted from oil palm (Elaeis guineensis), a high oil-producing tropical plant that also rich in phytochemicals. The major phenolic components in OPP are identified as caffeoylshikimic acid, protocatechuic acid and p-hydroxybenzoic acid. OPP has been found to exert various positive health effects parallel to the well-established physiological benefits of polyphenols. It has been shown that OPP protects against early type 2 diabetes and encouraging results suggest its role in modulating the development of diabetes. The current study aims to investigate and determine the effects of oil palm phenolics (OPP) on the blood glucose control in patients with uncontrolled insulin treated type 2 diabetes mellitus.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Penang
    • Seberang Jaya, Penang, Malaysia, 13700
      • Seberang Jaya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is currently injecting an insulin dosage of >= 1.0 unit/kilogram/day.
• Subject has a serum glycosylated haemoglobin (HbA1c) >= 9.
• Subject has fasting plasma glucose level of more than 7.0 mmol/L and less than 12.0 mmol/L.
• Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

• Subject with diabetic ketoacidosis or in coma.
• Subject with terminal cancer.
• Subject with renal failure (serum creatinine more than 200 umol/L).
• Subject with significant liver impairment (liver function test of 5 times more than the upper limit level).
• Subject with severe dementia and psychosis.
• Subject requires of long term corticosteroid treatment for the underlying disease such as connective tissue disorder.
• Subject with hemoglobinopathy or anemia.
• Subject underwent splenectomy or suffered from splenomegaly.
• Subject with chronic substance abuse such as chronic alcoholism or chronic opiate usage.
• Female subject of childbearing potential unless subject underwent bilateral tubal ligation, bilateral oophorectomy or hysterectomy previously.
• Subject or care giver is unable to perform self-monitoring of capillary blood glucose at home.
• Subject who have been included in any other clinical trial within the previous 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oil Palm Phenolics; 500 mg gallic acid equivalent (GAE), twice daily, 3 months	Dietary supplement: Oil Palm Phenolics; Palm fruit derived phenolics compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose level	Serum Glycosylated Haemogoblin (<5.7% indicates healthy, 5.7% - 6.4% indicates prediabetes, >6.5% indicates diabetes); Plasma glucose level of oral glucose tolerance test (<7.8 mmol/L indicates healthy, 7.8 mmol/L - 11 mmol/L indicates prediabetes, >11 mmol/L indicates diabetes); Fasting plasma glucose level (<5.6 mmol/L indicates healthy, 5.6 mmol/L - 6.9 mmol/L indicates prediabetes, >6.9 mmol/L indicates diabetes)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid Profile	Total cholesterol, Low-density lipoprotein, High-density lipoprotein, Triglycerides	3 months
Insulin Sensitivity	Model-derived Oral Glucose Insulin Sensitivity (OGIS) Index will be calculated using weight (kg), height (cm), glucose (mmol/L) and insulin (pmol/L).	3 months
Global Assessment of Efficacy	Very good, Good, No change, Unsatisfactory, Very unsatisfactory	3 months
Beta Cell Function	Homeostatic Model Assessment (HOMA2-B) to determine beta cell function	3 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: Clinical Research Centre, Malaysia; Malaysia Palm Oil Board

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: UNIDOPP-21102; NMRR-14-565-21102 (Registry Identifier: MREC, Ministry of Health, Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO