Red Palm Olein on Inflammation and Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- hs-C reactive protein (hsCRP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 25-45 years
- •waist circumference ≥ 90 cm for men and ≥ 80 cm for women
排除标准
- •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
结局指标
主要结局
hs-C reactive protein (hsCRP)
时间窗: 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)
次要结局
- Plasma lipid profile: HDL cholesterol (mmol/L)(12 weeks)
- Plasma lipid profile: Apolipoprotein B-100 (g/L)(12 weeks)
- Plasma lipid profile: LDL cholesterol (mmol/L)(12 weeks)
- Plasma antioxidant : beta carotene (ug/ml)(12 weeks)
- Dual-energy X-ray Absorptiometry (DEXA) Scan: AP Spine (percentage of fat)(12 weeks)
- Gut Microbiome: Differential Abundance Analysis(12 weeks)
- Plasma inflammatory marker: IL-1beta (pg/mL)(12 weeks)
- Plasma inflammatory marker: TNF-alpha (pg/mL)(12 weeks)
- Plasma lipid profile: Total cholesterol (mmol/L)(12 weeks)
- Plasma lipid profile: Apolipoprotein A-1 (g/L)(12 weeks)
- Plasma fatty acid composition: Oleic acid (C18:1 cis)(12 weeks)
- Plasma fatty acid composition: Linolenic acid (C18:3)(12 weeks)
- Urinary Total Phenolics(12 weeks)
- Gut Microbiome: Alpha and Beta Diversities(12 weeks)
- Gut Microbiome: Firmicutes to Bacteroides Ratio(12 weeks)
- Plasma fatty acid composition: Linoleic acid (C18:2n6 cis)(12 weeks)
- Dual-energy X-ray Absorptiometry (DEXA) Scan: Total body fat (z-score)(12 weeks)
- Dual-energy X-ray Absorptiometry (DEXA) Scan: Left femur (percentage of fat)(12 weeks)
- Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD total femur (g/cm2)(12 weeks)
- Plasma inflammatory marker: RBP-4 (ng/mL)(12 weeks)
- Plasma lipid profile: Triacylglycerol (mmol/L)(12 weeks)
- Plasma fatty acid composition: Palmitic acid (C16:0)(12 weeks)
- Dual-energy X-ray Absorptiometry (DEXA) Scan: BMD AP spine L1-L4 (g/cm2)(12 weeks)
- Dual-energy X-ray Absorptiometry (DEXA) Scan: AP spine L1-L4 (z-score)(12 weeks)
- Plasma inflammatory marker: sICAMs (ng/mL)(12 weeks)
- Plasma antioxidant : alpha tocopherol (ug/ml)(12 weeks)
- Plasma antioxidant : retinol (ug/ml)(12 weeks)
- Plasma antioxidant : alpha carotene (ug/ml)(12 weeks)
- Plasma inflammatory marker: IL-6 (pg/mL)(12 weeks)
- Plasma inflammatory marker: sVCAMs (ng/mL)(12 weeks)