Red Palm Olein on Inflammation and Gut Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diet Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Study Groups

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Red palm olein

Meals enriched with Red palm olein

Group Type EXPERIMENTAL

A 12-week parallel dietary intervention

Intervention Type 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.

Extra virgin coconut oil

Meals enriched with Extra virgin coconut oil

Group Type EXPERIMENTAL

A 12-week parallel dietary intervention

Intervention Type 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.

Extra virgin olive oil

Meals enriched with Extra virgin olive oil

Group Type EXPERIMENTAL

A 12-week parallel dietary intervention

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes