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

NCT02532088 | Withdrawn Phase 1 DMC

• 1 other identifier: PREDOPP-21100
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Level

  1. Serum Glycosylated Haemogoblin (\<5.7% indicates healthy, 5.7% - 6.4% indicates prediabetes, \>6.5% indicates diabetes) 2. 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) 3. 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 Outcomes (4)

• Insulin Sensitivity

  12 months

• Lipid profile

  12 months

• Global Assessment of Efficacy

  12 months

• Beta Cell Function

  12 months

Study Arms (2)

Oil Palm Phenolics

ACTIVE COMPARATOR

500 mg gallic acid equivalent (GAE), twice daily, 12 months

Dietary Supplement: Oil Palm Phenolics

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Oil Palm Phenolics DIETARY_SUPPLEMENT

Palm fruit derived phenolics compound

Oil Palm Phenolics

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Malaysia Palm Oil Board: collaborator
• Clinical Research Centre, Malaysia: collaborator

Study Sites (1)

Seberang Jaya Hospital

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kah Hay Yuen, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr.

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 25, 2015
• Study Start: May 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)