Blended Oil Beneficial for Blood Lipids Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline serum total cholesterol
研究概览
简要总结
To investigate the effects of two types of oil blends on blood lipid profile, glucose homeostasis, body composition, gut microflora and other markers of cardiometabolic disease risk in Chinese men and women with borderline hyperlipidemia
详细描述
The primary aims of this study is to evaluate the effects of consumption of two separate blends of cooking oil, containing rice bran, flaxseed and sesame oils, for a period of 8 weeks, on blood total cholesterol, total triglycerides, low-density and high-density lipoprotein cholesterol and metabolism in borderline hyperlipidaemic, 50 to 70 years old, Chinese, male and postmenopausal female, as compared to refined olive oil. The secondary aims of the study is to evaluate the effect of the two separate blends of cooking oil on markers of cardiometabolic diseases risk (including body composition, glucose homeostasis, markers of oxidative stress and chronic inflammation) and changes in gut microbiota composition and function.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and post-menopausal female,
- •Chinese ethnicity
- •Age ≥50 and ≤70 years
- •LDL cholesterol (measured) ≥3.06 mmol/l and ≤4.51 mmol/l
排除标准
- •Body Mass Index (BMI) > 27.5 kg/m
- •Having allergies / intolerances to the foods in the meal accompaniments of the study
- •Having undergone bariatric surgery
- •Having fasting glucose ≥7.0 mmol/l
- •Having heart, kidney (nephrotic syndrome), blood or thyroid dysfunctions
- •History of chronic liver diseases including NAFLD, liver cirrhosis or hepatic fibrosis or having history of HIV, Hep-B or Hep-C virus
- •Having prescription medication or Traditional Chinese Medicine or supplements known to affect blood lipid metabolism, in the opinion of the study investigators, in the last two weeks prior to screening
- •Having diabetes or chronic gastrointestinal disorders
- •Following any special diets (for medical or aesthetic reasons)
- •Having had diarrhea in the last 3 months
- •Having taken antibiotics in the last 3 months
研究组 & 干预措施
Refined olive oil (ROO)
Control
干预措施: Refined olive oil (ROO) (Other)
Blended Oil 1
BO1, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 2
干预措施: Blended Oil 1 (BO1) (Other)
Blended Oil 2
BO2, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 1
干预措施: Blended Oil 2 (BO2) (Other)
结局指标
主要结局
Change from baseline serum total cholesterol
时间窗: 8 weeks measured every 2 weeks
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Change from baseline serum low density lipoprotein cholesterol
时间窗: 8 weeks measured every 2 weeks
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Change from baseline serum total high density lipoprotein cholesterol
时间窗: 8 weeks measured every 2 weeks
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Change from baseline serum total triglycerides
时间窗: 8 weeks measured every 2 weeks
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
次要结局
- Change from baseline in bone mineral density(8 weeks)
- Change from baseline of serum insulin(8 weeks measured every 2 weeks)
- Change from baseline of serum glucose(8 weeks measured every 2 weeks)
- Change from baseline in plasma C-reactive protein(8 weeks measured every 2 weeks)
- Change from baseline in plasma oxidised low density lipoprotein(For 8 weeks measured every 2 weeks)
- Change from baseline in plasma glycated albumin(8 weeks measured every 2 weeks)
- Change from baseline in plasma Tumor necrosis factor-α(8 weeks measured every 2 weeks)
- Change from baseline in blood pressure(8 weeks measured every 2 weeks)
- Change from baseline in plasma fructosamine(8 weeks measured every 2 weeks)
- Change from baseline in plasma Interleukin-6(8 weeks measured every 2 weeks)
- Change from baseline in body fat composition percentage(8 weeks)
- Change from baseline in segmental % body fat(8 weeks measured every 2 weeks)
- Change from baseline in plasma Interleukin-1β(8 weeks measured every 2 weeks)
- Change from baseline in gut microflora function(8 weeks measured on days14 and 56)
- Change from baseline in Body weight(8 weeks measured every 2 weeks)
- Change from baseline in gut microflora composition(8 weeks measured on days14 and 56)
- Change in body circumference measures(8 weeks measured every 2 weeks)
研究者
JeyaKumar Henry
Principal Investigator
Clinical Nutrition Research Centre, Singapore