Red Palm Olein on Inflammation and Gut Health

NCT05791370 | Completed

• 1 other identifier: PD232/18
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet; Healthy

Keywords

red palm olein; extra virgin coconut oil; extra virgin olive oil; high sensitivity C-reactive protein; inflammation; obesity

Outcome Measures

Primary Outcomes (1)

• hs-C reactive protein (hsCRP)

  Changes in the mean of plasma hs-CRP at the endpoint relative to the baseline. Plasma hsCRP will be measured using an immunoturbidimetric method, fibrinogen by Clauss method (Dade)

  12 weeks

Secondary Outcomes (30)

• Plasma lipid profile: Total cholesterol (mmol/L)

  12 weeks

• Plasma lipid profile: LDL cholesterol (mmol/L)

  12 weeks

• Plasma lipid profile: HDL cholesterol (mmol/L)

  12 weeks

• Plasma lipid profile: Triacylglycerol (mmol/L)

  12 weeks

• Plasma lipid profile: Apolipoprotein B-100 (g/L)

  12 weeks

Study Arms (3)

Red palm olein

EXPERIMENTAL

Meals enriched with Red palm olein

Dietary Supplement: A 12-week parallel dietary intervention

Extra virgin coconut oil

EXPERIMENTAL

Meals enriched with Extra virgin coconut oil

Dietary Supplement: A 12-week parallel dietary intervention

Extra virgin olive oil

EXPERIMENTAL

Meals enriched with Extra virgin olive oil

Dietary Supplement: A 12-week parallel dietary intervention

Interventions

A 12-week parallel dietary intervention DIETARY_SUPPLEMENT

Subjects consumed 3 isocaloric meals prepared with the 3 oils for a duration of 12 weeks. The test meals were given for 5-day a week and contained 27-30% energy fat, with 2/3 (20% energy fat) replaced by experimental fat.

Extra virgin coconut oil; Extra virgin olive oil; Red palm olein

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Malaysia Palm Oil Board: lead
• Universiti Putra Malaysia: collaborator

Study Sites (1)

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (1)

• Teng KT, Loganathan R, Chew BH, Khang TF. Diverse impacts of red palm olein, extra virgin coconut oil and extra virgin olive oil on cardiometabolic risk markers in individuals with central obesity: a randomised trial. Eur J Nutr. 2024 Jun;63(4):1225-1239. doi: 10.1007/s00394-024-03338-6. Epub 2024 Feb 19.

  PMID: 38372798 DERIVED

MeSH Terms

Conditions

Inflammation; Obesity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Kim Tiu Teng, PhD

  Malaysia Palm Oil Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: We recruited a total of 156 overweight individuals, aged 25-45 years, with waist circumference ≥ 90 cm for men and ≥ 80 cm for women in a single-blind 3-arm randomised controlled trial. The participants consumed isocaloric diets (\~ 2400 kcal) enriched with red palm olein (RPOO), extra virgin coconut oil (EVCO) and extra virgin olive oil (EVOO, as a control) for a 12-week duration

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: March 30, 2023
• Study Start: January 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: November 30, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)