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Completed

NCT Number: NCT05791370

Red Palm Olein on Inflammation and Gut Health

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.

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Key information

Conditions

Diet Body Weight Healthy Inflammation Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysian Palm Oil Board

Kajang, Selangor, 43000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. hs-C reactive protein (hsCRP)

    Time frame: 12 weeks

    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)

Secondary outcomes

  1. Plasma lipid profile: Total cholesterol (mmol/L)

    Time frame: 12 weeks

    Changes in the mean of plasma Total cholesterol (mmol/L) at the endpoint relative to the baseline. Total cholesterol analysis will be performed by enzymatic method by an accredited clinical laboratory (Pathology & Clinical Laboratory (M) Sdn. Bhd, Malaysia).

  2. Plasma lipid profile: LDL cholesterol (mmol/L)

    Time frame: 12 weeks

    Changes in the mean of plasma LDL cholesterol (mmol/L) at the endpoint relative to the baseline. LDL cholesterol will be analysed by Friedewald calculation by an accredited clinical laboratory (Pathology & Clinical Laboratory (M) Sdn. Bhd, Malaysia).

  3. Plasma lipid profile: HDL cholesterol (mmol/L)

    Time frame: 12 weeks

    Changes in the mean of plasma HDL cholesterol (mmol/L) at the endpoint relative to the baseline. Plasma HDL cholesterol will be analysed by elimination / catalase method by an accredited clinical laboratory (Pathology & Clinical Laboratory (M) Sdn. Bhd, Malaysia).

  4. Plasma lipid profile: Triacylglycerol (mmol/L)

    Time frame: 12 weeks

    Changes in the mean of plasma Triacylglycerol (mmol/L) at the endpoint relative to the baseline. Plasma triglycerides will be analysed by glycerol phosphate oxidase method by an accredited clinical laboratory (Pathology & Clinical Laboratory (M) Sdn. Bhd, Malaysia).

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

    Time frame: 12 weeks

    Changes in the mean of plasma Apolipoprotein B-100 (g/L) at the endpoint relative to the baseline. Plasma apolipoprotein B-100 (apo B-100) will be analysed by PEG enhanced immunoturbidimetric method by an accredited clinical laboratory (Pathology & Clinical Laboratory (M) Sdn. Bhd, Malaysia).

  6. Plasma lipid profile: Apolipoprotein A-1 (g/L)

    Time frame: 12 weeks

    Changes in the mean of plasma Apolipoprotein A-1 (g/L) at the endpoint relative to the baseline. Plasma Apolipoprotein A-1 will be analysed by PEG enhanced immunoturbidimetric method by an accredited clinical laboratory (Pathology & Clinical Laboratory (M) Sdn. Bhd, Malaysia).

  7. Plasma fatty acid composition: Palmitic acid (C16:0)

    Time frame: 12 weeks

    Changes in the mean of plasma fatty acid composition (Palmitic acid (C16:0)) at the endpoint relative to the baseline. Lipids will be extracted from the plasma using Folch method and then trans-methylated with methanol and sulphuric acid. The fatty acid composition of the test fats will be determined by converting fatty acids of triacylglyceride to fatty acid methyl esters (FAME) according to AOCS Official Method Ch 1-91. The fatty acid composition will be determined according to AOCS Official Method Ce 1a-13 using Perkin Elmer Autosystem Gas Chromatography (PerkinElmer, Inc., California, USA). Data will be reported in g/100 g total fatty acids.

  8. Plasma fatty acid composition: Oleic acid (C18:1 cis)

    Time frame: 12 weeks

    Changes in the mean of plasma fatty acid composition (Oleic acid (C18:1 cis)) at the endpoint relative to the baseline. Lipids will be extracted from the plasma using Folch method and then trans-methylated with methanol and sulphuric acid. The fatty acid composition of the test fats will be determined by converting fatty acids of triacylglyceride to fatty acid methyl esters (FAME) according to AOCS Official Method Ch 1-91. The fatty acid composition will be determined according to AOCS Official Method Ce 1a-13 using Perkin Elmer Autosystem Gas Chromatography (PerkinElmer, Inc., California, USA). Data will be reported in g/100 g total fatty acids.

  9. Plasma fatty acid composition: Linoleic acid (C18:2n6 cis)

    Time frame: 12 weeks

    Changes in the mean of plasma fatty acid composition (Linoleic acid (C18:2n6 cis)) at the endpoint relative to the baseline. Lipids will be extracted from the plasma using Folch method and then trans-methylated with methanol and sulphuric acid. The fatty acid composition of the test fats will be determined by converting fatty acids of triacylglyceride to fatty acid methyl esters (FAME) according to AOCS Official Method Ch 1-91. The fatty acid composition will be determined according to AOCS Official Method Ce 1a-13 using Perkin Elmer Autosystem Gas Chromatography (PerkinElmer, Inc., California, USA). Data will be reported in g/100 g total fatty acids.

  10. Plasma fatty acid composition: Linolenic acid (C18:3)

    Time frame: 12 weeks

    Changes in the mean of plasma fatty acid composition (Linolenic acid (C18:3)) at the endpoint relative to the baseline. Lipids will be extracted from the plasma using Folch method and then trans-methylated with methanol and sulphuric acid. The fatty acid composition of the test fats will be determined by converting fatty acids of triacylglyceride to fatty acid methyl esters (FAME) according to AOCS Official Method Ch 1-91. The fatty acid composition will be determined according to AOCS Official Method Ce 1a-13 using Perkin Elmer Autosystem Gas Chromatography (PerkinElmer, Inc., California, USA). Data will be reported in g/100 g total fatty acids.

  11. Plasma antioxidant : alpha tocopherol (ug/ml)

    Time frame: 12 weeks

    Changes in the mean of plasma antioxidant (alpha tocopherol) at the endpoint relative to the baseline. The quantities of lipid-soluble antioxidants will be determined by reverse-phase HPLC (Agilent 1260 Infinity, US) and reported in ug/ml.

  12. Plasma antioxidant : retinol (ug/ml)

    Time frame: 12 weeks

    Changes in the mean of plasma antioxidant (retinol) at the endpoint relative to the baseline. The quantities of lipid-soluble antioxidants will be determined by reverse-phase HPLC (Agilent 1260 Infinity, US) and reported in ug/ml.

  13. Plasma antioxidant : alpha carotene (ug/ml)

    Time frame: 12 weeks

    Changes in the mean of plasma antioxidant (alpha carotene) at the endpoint relative to the baseline. The quantities of lipid-soluble antioxidants will be determined by reverse-phase HPLC (Agilent 1260 Infinity, US) and reported in ug/ml.

  14. Plasma antioxidant : beta carotene (ug/ml)

    Time frame: 12 weeks

    Changes in the mean of plasma antioxidant (beta carotene) at the endpoint relative to the baseline. The quantities of lipid-soluble antioxidants will be determined by reverse-phase HPLC (Agilent 1260 Infinity, US) and reported in ug/ml.

  15. Urinary Total Phenolics

    Time frame: 12 weeks

    Changes in the mean of urinary total phenolics at the endpoint relative to the baseline. Total phenolic content will be measured in urine samples using the Folin-Ciocalteu assay after a solid-phase clean-up

  16. Dual-energy X-ray Absorptiometry (DEXA) Scan: Total body fat (z-score)

    Time frame: 12 weeks

    Changes in DEXA parameter (Total body fat (z-score)) at the endpoint relative to the baseline. DEXA scanning will be conducted in a subset of participants by trained personnel in the Prince Court Medical Centre, Malaysia with a Lunar Prodigy Advance densitometer (General Electric, Milwaukee, WI, USA).

  17. Dual-energy X-ray Absorptiometry (DEXA) Scan: AP Spine (percentage of fat)

    Time frame: 12 weeks

    Changes in DEXA parameter (AP Spine (percentage of fat) at the endpoint relative to the baseline. DEXA scanning will be conducted in a subset of participants by trained personnel in the Prince Court Medical Centre, Malaysia with a Lunar Prodigy Advance densitometer (General Electric, Milwaukee, WI, USA).

  18. Dual-energy X-ray Absorptiometry (DEXA) Scan: Left femur (percentage of fat)

    Time frame: 12 weeks

    Changes in DEXA parameter (Total body fat (Left femur (percentage of fat) at the endpoint relative to the baseline. DEXA scanning will be conducted in a subset of participants by trained personnel in the Prince Court Medical Centre, Malaysia with a Lunar Prodigy Advance densitometer (General Electric, Milwaukee, WI, USA).

  19. Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD AP spine L1-L4 (g/cm2)

    Time frame: 12 weeks

    Changes in DEXA parameter (BMD AP spine L1-L4 (g/cm2)) at the endpoint relative to the baseline. DEXA scanning will be conducted in a subset of participants by trained personnel in the Prince Court Medical Centre, Malaysia with a Lunar Prodigy Advance densitometer (General Electric, Milwaukee, WI, USA).

  20. Dual-energy X-ray Absorptiometry (DEXA) Scan: AP spine L1-L4 (z-score)

    Time frame: 12 weeks

    Changes in DEXA parameter (AP spine L1-L4 (z-score)) at the endpoint relative to the baseline. DEXA scanning will be conducted in a subset of participants by trained personnel in the Prince Court Medical Centre, Malaysia with a Lunar Prodigy Advance densitometer (General Electric, Milwaukee, WI, USA).

  21. Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD total femur (g/cm2)

    Time frame: 12 weeks

    Changes in DEXA parameter (BMD total femur (g/cm2)) at the endpoint relative to the baseline. DEXA scanning will be conducted in a subset of participants by trained personnel in the Prince Court Medical Centre, Malaysia with a Lunar Prodigy Advance densitometer (General Electric, Milwaukee, WI, USA).

  22. Gut Microbiome: Alpha and Beta Diversities

    Time frame: 12 weeks

    Changes in gut microbiome data: Alpha and Beta Diversities at the endpoint relative to the baseline. The analyses will be done on the complete OTU count table. Sample ordination in principal coordinate axis (PCoA) space will be visualised using the first two principal coordinate axes. NGS Amplicon sequencing and gut microbiota analyses will be performed by Apical Scientific Sdn Bhd.

  23. Gut Microbiome: Firmicutes to Bacteroides Ratio

    Time frame: 12 weeks

    Changes in gut microbiome (Firmicutes to Bacteroides Ratio) at the endpoint relative to the baseline. Computation of Firmicutes to Bacteroides (F/B) ratio using the complete microbial count table. NGS Amplicon sequencing and gut microbiota analyses will be performed by Apical Scientific Sdn Bhd.

  24. Gut Microbiome: Differential Abundance Analysis

    Time frame: 12 weeks

    Changes in gut microbiome (Differential Abundance Analysis) at the endpoint relative to the baseline. NGS Amplicon sequencing and gut microbiota analyses will be performed by Apical Scientific Sdn Bhd.

  25. Plasma inflammatory marker: IL-6 (pg/mL)

    Time frame: 12 weeks

    Changes in Plasma inflammatory marker: IL-6 (pg/mL) at the endpoint relative to the baseline. Plasma IL-6 will be measured by quantitative sandwich enzyme immunoassay (R&D Systems, USA).

  26. Plasma inflammatory marker: IL-1beta (pg/mL)

    Time frame: 12 weeks

    Changes in Plasma inflammatory marker:IL-1beta (pg/mL) at the endpoint relative to the baseline. Plasma IL-1beta will be measured by quantitative sandwich enzyme immunoassay (R&D Systems, USA).

  27. Plasma inflammatory marker: TNF-alpha (pg/mL)

    Time frame: 12 weeks

    Changes in Plasma inflammatory marker: TNF-alpha (pg/mL) at the endpoint relative to the baseline. Plasma TNF-alpha will be measured by quantitative sandwich enzyme immunoassay (R&D Systems, USA).

  28. Plasma inflammatory marker: sICAMs (ng/mL)

    Time frame: 12 weeks

    Changes in Plasma inflammatory marker: sICAMs (ng/mL) at the endpoint relative to the baseline. Plasma sICAM-1 will be measured by quantitative sandwich enzyme immunoassay (R&D Systems, USA).

  29. Plasma inflammatory marker: sVCAMs (ng/mL)

    Time frame: 12 weeks

    Changes in Plasma inflammatory marker: sVCAMs (ng/mL) at the endpoint relative to the baseline. Plasma sVCAM-1 will be measured by quantitative sandwich enzyme immunoassay (R&D Systems, USA).

  30. Plasma inflammatory marker: RBP-4 (ng/mL)

    Time frame: 12 weeks

    Changes in Plasma inflammatory marker: RBP4 at the endpoint relative to the baseline. Plasma RBP-4 will be measured by quantitative sandwich enzyme immunoassay (R&D Systems, USA).

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • Universiti Putra Malaysia

Registry information

Acronym: RPO

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Mar 30, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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