Red Palm Olein on Inflammation and Gut Health
- Conditions
- HealthyDiet
- Interventions
- Dietary Supplement: A 12-week parallel dietary intervention
- Registration Number
- NCT05791370
- Lead Sponsor
- Malaysia Palm Oil Board
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- aged 25-45 years
- waist circumference ≥ 90 cm for men and ≥ 80 cm for women
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Red palm olein A 12-week parallel dietary intervention Meals enriched with Red palm olein Extra virgin coconut oil A 12-week parallel dietary intervention Meals enriched with Extra virgin coconut oil Extra virgin olive oil A 12-week parallel dietary intervention Meals enriched with Extra virgin olive oil
- Primary Outcome Measures
Name Time Method hs-C reactive protein (hsCRP) 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 Outcome Measures
Name Time Method Plasma lipid profile: HDL cholesterol (mmol/L) 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).
Plasma lipid profile: Apolipoprotein B-100 (g/L) 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).
Plasma lipid profile: LDL cholesterol (mmol/L) 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).
Plasma antioxidant : beta carotene (ug/ml) 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.
Dual-energy X-ray Absorptiometry (DEXA) Scan: AP Spine (percentage of fat) 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).
Gut Microbiome: Differential Abundance Analysis 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.
Plasma inflammatory marker: IL-1beta (pg/mL) 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).
Plasma inflammatory marker: TNF-alpha (pg/mL) 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).
Plasma lipid profile: Total cholesterol (mmol/L) 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).
Plasma lipid profile: Apolipoprotein A-1 (g/L) 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).
Plasma fatty acid composition: Oleic acid (C18:1 cis) 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.
Plasma fatty acid composition: Linolenic acid (C18:3) 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.
Urinary Total Phenolics 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
Gut Microbiome: Alpha and Beta Diversities 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.
Gut Microbiome: Firmicutes to Bacteroides Ratio 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.
Plasma fatty acid composition: Linoleic acid (C18:2n6 cis) 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.
Dual-energy X-ray Absorptiometry (DEXA) Scan: Total body fat (z-score) 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).
Dual-energy X-ray Absorptiometry (DEXA) Scan: Left femur (percentage of fat) 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).
Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD total femur (g/cm2) 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).
Plasma inflammatory marker: RBP-4 (ng/mL) 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).
Plasma lipid profile: Triacylglycerol (mmol/L) 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).
Plasma fatty acid composition: Palmitic acid (C16:0) 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.
Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD AP spine L1-L4 (g/cm2) 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).
Dual-energy X-ray Absorptiometry (DEXA) Scan: AP spine L1-L4 (z-score) 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).
Plasma inflammatory marker: sICAMs (ng/mL) 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).
Plasma antioxidant : alpha tocopherol (ug/ml) 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.
Plasma antioxidant : retinol (ug/ml) 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.
Plasma antioxidant : alpha carotene (ug/ml) 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.
Plasma inflammatory marker: IL-6 (pg/mL) 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).
Plasma inflammatory marker: sVCAMs (ng/mL) 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).
Trial Locations
- Locations (1)
Malaysian Palm Oil Board
🇲🇾Kajang, Selangor, Malaysia