DietRPONCT05791370
Red Palm Olein on Inflammation and Gut Health
A study testing A 12-week parallel dietary intervention in people with Diet and Healthy, run by Malaysia Palm Oil Board at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- What is being tested?
- A 12-week parallel dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 25-45 years
- waist circumference ≥ 90 cm for men and ≥ 80 cm for women
Who cannot join
- 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
Show all 10Show fewer
- on antihypertensive or lipid-lowering medication
- lactating
- pregnant
- smoking
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Being tested
- A 12-week parallel dietary intervention
- Keywords
- red palm olein, extra virgin coconut oil, extra virgin olive oil, high sensitivity C-reactive protein, inflammation, obesity
- Medical subject headings
- Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 12-week parallel dietary interventionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Red palm olein | Experimental | Meals enriched with Red palm olein Receives: Dietary Supplement: A 12-week parallel dietary intervention |
| Extra virgin coconut oil | Experimental | Meals enriched with Extra virgin coconut oil Receives: Dietary Supplement: A 12-week parallel dietary intervention |
| Extra virgin olive oil | Experimental | Meals enriched with Extra virgin olive oil Receives: Dietary Supplement: A 12-week parallel dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (30)
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Jan 2019
- Primary completion30 May 2019
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Sponsor
- Investigators
- Kim Tiu Teng, PhD, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791370
- Sponsor's protocol ID
- PD232/18
- Acronym
- RPO
- Status last verified
- Mar 2023
- First submitted
- 20 Dec 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data , provided requested specifically for scientific analysis purposes
Publications
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.
PubMed 38372798
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Palm Olein on Inflammation and Gut Health
- ClinicalTrials.gov ID
- NCT05791370
- Acronym / sponsor ID
- RPO / PD232/18
- Keywords
- red palm olein, extra virgin coconut oil, extra virgin olive oil, high sensitivity C-reactive protein, inflammation, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- Universiti Putra Malaysia
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Red palm olein | Experimental | Dietary Supplement: A 12-week parallel dietary interventionMeals enriched with Red palm olein |
| Extra virgin coconut oil | Experimental | Dietary Supplement: A 12-week parallel dietary interventionMeals enriched with Extra virgin coconut oil |
| Extra virgin olive oil | Experimental | Dietary Supplement: A 12-week parallel dietary interventionMeals enriched with Extra virgin olive oil |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 25-45 years
- waist circumference ≥ 90 cm for men and ≥ 80 cm for women
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 12-week parallel dietary interventionSubjects 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. | Dietary supplement | Extra virgin coconut oil, Extra virgin olive oil, Red palm olein |
Primary outcome
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)
30 secondary outcomes
Plasma lipid profile: Total cholesterol (mmol/L)
Time frame: 12 weeks
Plasma lipid profile: LDL cholesterol (mmol/L)
Time frame: 12 weeks
Plasma lipid profile: HDL cholesterol (mmol/L)
Time frame: 12 weeks
Plasma lipid profile: Triacylglycerol (mmol/L)
Time frame: 12 weeks
Plasma lipid profile: Apolipoprotein B-100 (g/L)
Time frame: 12 weeks
Plasma lipid profile: Apolipoprotein A-1 (g/L)
Time frame: 12 weeks
Plasma fatty acid composition: Palmitic acid (C16:0)
Time frame: 12 weeks
Plasma fatty acid composition: Oleic acid (C18:1 cis)
Time frame: 12 weeks
Plasma fatty acid composition: Linoleic acid (C18:2n6 cis)
Time frame: 12 weeks
Plasma fatty acid composition: Linolenic acid (C18:3)
Time frame: 12 weeks
Plasma antioxidant : alpha tocopherol (ug/ml)
Time frame: 12 weeks
Plasma antioxidant : retinol (ug/ml)
Time frame: 12 weeks
Plasma antioxidant : alpha carotene (ug/ml)
Time frame: 12 weeks
Plasma antioxidant : beta carotene (ug/ml)
Time frame: 12 weeks
Urinary Total Phenolics
Time frame: 12 weeks
Dual-energy X-ray Absorptiometry (DEXA) Scan: Total body fat (z-score)
Time frame: 12 weeks
Dual-energy X-ray Absorptiometry (DEXA) Scan: AP Spine (percentage of fat)
Time frame: 12 weeks
Dual-energy X-ray Absorptiometry (DEXA) Scan: Left femur (percentage of fat)
Time frame: 12 weeks
Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD AP spine L1-L4 (g/cm2)
Time frame: 12 weeks
Dual-energy X-ray Absorptiometry (DEXA) Scan: AP spine L1-L4 (z-score)
Time frame: 12 weeks
Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD total femur (g/cm2)
Time frame: 12 weeks
Gut Microbiome: Alpha and Beta Diversities
Time frame: 12 weeks
Gut Microbiome: Firmicutes to Bacteroides Ratio
Time frame: 12 weeks
Gut Microbiome: Differential Abundance Analysis
Time frame: 12 weeks
Plasma inflammatory marker: IL-6 (pg/mL)
Time frame: 12 weeks
Plasma inflammatory marker: IL-1beta (pg/mL)
Time frame: 12 weeks
Plasma inflammatory marker: TNF-alpha (pg/mL)
Time frame: 12 weeks
Plasma inflammatory marker: sICAMs (ng/mL)
Time frame: 12 weeks
Plasma inflammatory marker: sVCAMs (ng/mL)
Time frame: 12 weeks
Plasma inflammatory marker: RBP-4 (ng/mL)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 38372798Teng 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.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data , provided requested specifically for scientific analysis purposes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Tiu Teng, PhD principal investigator
Malaysia Palm Oil Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 12-week parallel dietary intervention in people with Diet and Healthy, run by Malaysia Palm Oil Board at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hs-C reactive protein (hsCRP) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.