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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 October 2021
• Main ID: NCT02532088
• Date of registration: 10/08/2015
• Prospective Registration: Yes
• Primary sponsor: Universiti Sains Malaysia
• Public title: Modulating Effects of Oil Palm Phenolics in Subjects With Pre-diabetes PREDOPP
• Scientific title: Modulating Effects of Oil Palm Phenolics in Subjects With Pre-diabetes
• Date of first enrolment: May 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02532088
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Malaysia

Contacts

• Name: Kah Hay Yuen, PhD
• Affiliation: Universiti Sains Malaysia

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prediabetes

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Oil Palm Phenolics

Primary Outcome(s)

Blood Glucose Level [Time Frame: 12 months]

Secondary Outcome(s)

Lipid profile [Time Frame: 12 months]

Global Assessment of Efficacy [Time Frame: 12 months]

Insulin Sensitivity [Time Frame: 12 months]

Beta Cell Function [Time Frame: 12 months]

Secondary ID(s)

PREDOPP-21100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Clinical Research Centre, Malaysia

Malaysia Palm Oil Board