Hyperlipidemias
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERRefined olive oil (ROO)
Consumption of chicken dishes made with ROO for a period of 8 weeks
OTHERBlended Oil 1 (BO1)
Consumption of chicken dishes made with BO1 for a period of 8 weeks
OTHERBlended Oil 2 (BO2)
Consumption of chicken dishes made with BO2 for a period of 8 weeks
Sponsors
Wilmar International Limited
National University of Singapore
Agency for Science, Technology and Research
JeyaKumar Henry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and post-menopausal female, * Chinese ethnicity * Age ≥50 and ≤70 years * LDL cholesterol (measured) ≥3.06 mmol/l and ≤4.51 mmol/l
Exclusion criteria
* Body Mass Index (BMI) \> 27.5 kg/m2. * 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) * Smoking * Having had diarrhea in the last 3 months * Having taken antibiotics in the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline serum total cholesterol | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in plasma glycated albumin | 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
| Change from baseline in plasma C-reactive protein | 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
| Change from baseline in plasma Interleukin-6 | 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
| Change from baseline in plasma Interleukin-1β | 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
| Change from baseline in plasma Tumor necrosis factor-α | 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
| Change from baseline in body fat composition percentage | 8 weeks | measured using DEXA (Dual-Energy X-ray Absorptiometry) |
| Change from baseline of serum glucose | 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 in blood pressure | 8 weeks measured every 2 weeks | Measured using Omron blood pressure monitor after an overnight fast in a seated posture, at rest. Blood pressure measured for a minimum of 3 times and the average of the final 2 readings were taken, ensuring that they were within 10 mmHg of each other. |
| Change from baseline in gut microflora composition | 8 weeks measured on days14 and 56 | Assessed using gut metagenome and metatranscriptome profiling |
| Change from baseline in gut microflora function | 8 weeks measured on days14 and 56 | Assessed using gut metagenome and metatranscriptome profiling |
| Change from baseline in Body weight | 8 weeks measured every 2 weeks | Body impedance assessments (BIA) |
| Change from baseline in segmental % body fat | 8 weeks measured every 2 weeks | Body impedance assessments (BIA) |
| Change in body circumference measures | 8 weeks measured every 2 weeks | Using measuring tape |
| Change from baseline in bone mineral density | 8 weeks | measured using DEXA (Dual-Energy X-ray Absorptiometry) |
| Change from baseline of serum insulin | 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 in plasma oxidised low density lipoprotein | For 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
| Change from baseline in plasma fructosamine | 8 weeks measured every 2 weeks | Blood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collectionBlood will be collected in EDTA tubes after an overnight fast, centrifuged and frozen within 2 hours of collection |
Countries
Singapore
Outcome results
None listed