Red Palm Olein on Inflammation and Gut Health

Healthy Clinical Trial

— RPO  

Official title:

Red Palm Olein on Inflammation and Gut Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05791370
• Other study ID #: PD232/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: November 30, 2022
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet
• Healthy
• Inflammation

Intervention

Dietary Supplement:
• A 12-week parallel dietary intervention
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.

Locations

Country	Name	City	State
Malaysia	Malaysian Palm Oil Board	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma lipid profile: Total cholesterol (mmol/L)	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).	12 weeks
Secondary	Plasma lipid profile: LDL cholesterol (mmol/L)	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).	12 weeks
Secondary	Plasma lipid profile: HDL cholesterol (mmol/L)	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).	12 weeks
Secondary	Plasma lipid profile: Triacylglycerol (mmol/L)	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).	12 weeks
Secondary	Plasma lipid profile: Apolipoprotein B-100 (g/L)	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).	12 weeks
Secondary	Plasma lipid profile: Apolipoprotein A-1 (g/L)	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).	12 weeks
Secondary	Plasma fatty acid composition: Palmitic acid (C16:0)	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.	12 weeks
Secondary	Plasma fatty acid composition: Oleic acid (C18:1 cis)	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.	12 weeks
Secondary	Plasma fatty acid composition: Linoleic acid (C18:2n6 cis)	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.	12 weeks
Secondary	Plasma fatty acid composition: Linolenic acid (C18:3)	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.	12 weeks
Secondary	Plasma antioxidant : alpha tocopherol (ug/ml)	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 weeks
Secondary	Plasma antioxidant : retinol (ug/ml)	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.	12 weeks
Secondary	Plasma antioxidant : alpha carotene (ug/ml)	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.	12 weeks
Secondary	Plasma antioxidant : beta carotene (ug/ml)	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.	12 weeks
Secondary	Urinary Total Phenolics	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	12 weeks
Secondary	Dual-energy X-ray Absorptiometry (DEXA) Scan: Total body fat (z-score)	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).	12 weeks
Secondary	Dual-energy X-ray Absorptiometry (DEXA) Scan: AP Spine (percentage of fat)	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).	12 weeks
Secondary	Dual-energy X-ray Absorptiometry (DEXA) Scan: Left femur (percentage of fat)	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).	12 weeks
Secondary	Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD AP spine L1-L4 (g/cm2)	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).	12 weeks
Secondary	Dual-energy X-ray Absorptiometry (DEXA) Scan: AP spine L1-L4 (z-score)	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).	12 weeks
Secondary	Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD total femur (g/cm2)	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).	12 weeks
Secondary	Gut Microbiome: Alpha and Beta Diversities	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.	12 weeks
Secondary	Gut Microbiome: Firmicutes to Bacteroides Ratio	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.	12 weeks
Secondary	Gut Microbiome: Differential Abundance Analysis	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.	12 weeks
Secondary	Plasma inflammatory marker: IL-6 (pg/mL)	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).	12 weeks
Secondary	Plasma inflammatory marker: IL-1beta (pg/mL)	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).	12 weeks
Secondary	Plasma inflammatory marker: TNF-alpha (pg/mL)	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).	12 weeks
Secondary	Plasma inflammatory marker: sICAMs (ng/mL)	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).	12 weeks
Secondary	Plasma inflammatory marker: sVCAMs (ng/mL)	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).	12 weeks
Secondary	Plasma inflammatory marker: RBP-4 (ng/mL)	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).	12 weeks