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Red Palm Olein on Inflammation and Gut Health (RPO)

M

Malaysia Palm Oil Board

Status

Completed

Conditions

Healthy
Diet

Treatments

Dietary Supplement: A 12-week parallel dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05791370
PD232/18

Details and patient eligibility

About

A parallel intervention was conducted to test the effect of consuming diets enriched with red palm olein (RPOO), extra virgin coconut oil (EVCO) and extra virgin olive oil (EVOO; positive control) in centrally obese individuals over a 12-week period. Following the screening of the subjects' health status, including their biochemical and lipid profiles, the subjects completed a 12-week dietary intervention. Both fasting blood and urine samples were collected at baseline (day 0) and endpoint (week 12); measurements were taken in duplicates. All data collected were blinded to the investigators by an independent third party until the completion of the analysis.

Full description

The study was conducted according to the guidelines laid down in the Declaration of Helsinki. All subjects gave informed consent prior to the commencement of the study. A parallel intervention was conducted to test the effect of consuming diets enriched with red palm olein (RPOO), extra virgin coconut oil (EVCO) and extra virgin olive oil (EVOO; positive control) in centrally obese individuals over a 12-week period. Following the screening of the subjects' health status, including their biochemical and lipid profiles, the subjects completed a 12-week dietary intervention. Both fasting blood and urine samples were collected at baseline (day 0) and endpoint (week 12); measurements were taken in duplicates. All data collected were blinded to the investigators by an independent third party until the completion of the analysis. The efficacy of the blinding procedure was assessed by evaluating the compliance of participants using the visual analogue scale to the experimental diets. Statistical analysis was conducted independently by a statistician not involved in the conduct of the study.

Enrollment

156 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • aged 25-45 years
  • waist circumference ≥ 90 cm for men and ≥ 80 cm for women

Exclusion criteria

  • BMI ≤ 18.5 kg/m2
  • medical history of cardiovascular diseases
  • positive for diabetes or dyslipidemia
  • diagnosed with chronic illness
  • plasma total cholesterol > 6.5 mmol/L
  • triacylglycerol >4.5 mmol/L
  • on antihypertensive or lipid-lowering medication
  • lactating
  • pregnant
  • smoking

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

156 participants in 3 patient groups

Red palm olein
Experimental group
Description:
Meals enriched with Red palm olein
Treatment:
Dietary Supplement: A 12-week parallel dietary intervention
Extra virgin coconut oil
Experimental group
Description:
Meals enriched with Extra virgin coconut oil
Treatment:
Dietary Supplement: A 12-week parallel dietary intervention
Extra virgin olive oil
Experimental group
Description:
Meals enriched with Extra virgin olive oil
Treatment:
Dietary Supplement: A 12-week parallel dietary intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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