Modulating Effects of Oil Palm Phenolics in Subjects With Pre-diabetes (PREDOPP)

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 subjects with pre-diabetes.

Study Overview

• Status: Withdrawn
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Oil Palm Phenolics

Detailed Description

Recent studies suggest the potential of polyphenols as a supplementary treatment to delay or prevent the onset of diabetes 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 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). In addition, polyphenols are able to regulate the key pathways involved in carbohydrate metabolism and hepatic glucose homeostasis. These include glycolysis, glycogenesis and gluconeogenesis, which are usually impaired in diabetes.

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 pre-diabetics.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

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 with "pre-diabetes", i.e. fasting plasma glucose level of more than 5.6 mmol/L and less than 7.0 mmol/L; or 2-hr plasma glucose load level of more than 7.8 mmol/L and less than 11.0 mmol/L.
• Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

• 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 pre-existing cardiovascular disease.
• 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 with other significant uncontrolled medical illnesses that may interfere with drug administration or interpretation of results.
• 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Active Comparator: Oil Palm Phenolics; 500 mg gallic acid equivalent (GAE), twice daily, 12 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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months
Lipid profile	Total cholesterol, Low-density lipoprotein, High-density lipoprotein, Triglycerides	12 months
Global Assessment of Efficacy	Very good, good, no change, unsatisfactory and very unsatisfactory	12 months
Beta Cell Function	Homeostatic Model Assessment (HOMA2-B) to determine beta cell function	12 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 (Anticipated): May 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

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): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: PREDOPP-21100

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No