Clinical trial NCT05791370: Red Palm Olein on Inflammation and Gut Health
Official title: Red Palm Olein on Inflammation and Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Healthy
Keywords: red palm olein
extra virgin coconut oil
extra virgin olive oil
high sensitivity C-reactive protein
inflammation
obesity
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Putra Malaysia
First posted: 2023-03-30
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: hs-C reactive protein (hsCRP)
timeFrame: 12 weeks
Secondary outcomes:
measure: Plasma lipid profile: Total cholesterol (mmol/L)
timeFrame: 12 weeks
measure: Plasma lipid profile: LDL cholesterol (mmol/L)
timeFrame: 12 weeks
measure: Plasma lipid profile: HDL cholesterol (mmol/L)
timeFrame: 12 weeks
measure: Plasma lipid profile: Triacylglycerol (mmol/L)
timeFrame: 12 weeks
measure: Plasma lipid profile: Apolipoprotein B-100 (g/L)
timeFrame: 12 weeks
measure: Plasma lipid profile: Apolipoprotein A-1 (g/L)
timeFrame: 12 weeks
measure: Plasma fatty acid composition: Palmitic acid (C16:0)
timeFrame: 12 weeks
measure: Plasma fatty acid composition: Oleic acid (C18:1 cis)
timeFrame: 12 weeks
measure: Plasma fatty acid composition: Linoleic acid (C18:2n6 cis)
timeFrame: 12 weeks
measure: Plasma fatty acid composition: Linolenic acid (C18:3)
timeFrame: 12 weeks
measure: Plasma antioxidant : alpha tocopherol (ug/ml)
timeFrame: 12 weeks
measure: Plasma antioxidant : retinol (ug/ml)
timeFrame: 12 weeks
measure: Plasma antioxidant : alpha carotene (ug/ml)
timeFrame: 12 weeks
measure: Plasma antioxidant : beta carotene (ug/ml)
timeFrame: 12 weeks
measure: Urinary Total Phenolics
timeFrame: 12 weeks
measure: Dual-energy X-ray Absorptiometry (DEXA) Scan: Total body fat (z-score)
timeFrame: 12 weeks
measure: Dual-energy X-ray Absorptiometry (DEXA) Scan: AP Spine (percentage of fat)
timeFrame: 12 weeks
measure: Dual-energy X-ray Absorptiometry (DEXA) Scan: Left femur (percentage of fat)
timeFrame: 12 weeks
measure: Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD AP spine L1-L4 (g/cm2)
timeFrame: 12 weeks
measure: Dual-energy X-ray Absorptiometry (DEXA) Scan: AP spine L1-L4 (z-score)
timeFrame: 12 weeks
measure: Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD total femur (g/cm2)
timeFrame: 12 weeks
measure: Gut Microbiome: Alpha and Beta Diversities
timeFrame: 12 weeks
measure: Gut Microbiome: Firmicutes to Bacteroides Ratio
timeFrame: 12 weeks
measure: Gut Microbiome: Differential Abundance Analysis
timeFrame: 12 weeks
measure: Plasma inflammatory marker: IL-6 (pg/mL)
timeFrame: 12 weeks
measure: Plasma inflammatory marker: IL-1beta (pg/mL)
timeFrame: 12 weeks
measure: Plasma inflammatory marker: TNF-alpha (pg/mL)
timeFrame: 12 weeks
measure: Plasma inflammatory marker: sICAMs (ng/mL)
timeFrame: 12 weeks
measure: Plasma inflammatory marker: sVCAMs (ng/mL)
timeFrame: 12 weeks
measure: Plasma inflammatory marker: RBP-4 (ng/mL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Kim Tiu Teng, PhD
role: PRINCIPAL_INVESTIGATOR
References: