Blended Oil Beneficial for Blood Lipids Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Blended Oil Beneficial for Blood Lipids Management

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Other: Refined olive oil (ROO)
* Other: Blended Oil 1 (BO1)
* Other: Blended Oil 2 (BO2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Refined olive oil (ROO)<br>Control | Other: Refined olive oil (ROO)<br>* Consumption of chicken dishes made with ROO for a period of 8 weeks<br>|
| Experimental: Blended Oil 1<br>BO1, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 2 | Other: Blended Oil 1 (BO1)<br>* Consumption of chicken dishes made with BO1 for a period of 8 weeks<br>|
| Experimental: Blended Oil 2<br>BO2, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 1 | Other: Blended Oil 2 (BO2)<br>* Consumption of chicken dishes made with BO2 for a period of 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline serum total cholesterol | Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection | 8 weeks measured every 2 weeks | 
| Change from baseline serum low density lipoprotein cholesterol | Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection | 8 weeks measured every 2 weeks | 
| Change from baseline serum total high density lipoprotein cholesterol | Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection | 8 weeks measured every 2 weeks | 
| Change from baseline serum total triglycerides | Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection | 8 weeks measured every 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of serum glucose | Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection | 8 weeks measured every 2 weeks | 
| Change from baseline of serum insulin | Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection | 8 weeks measured every 2 weeks | 
| Change from baseline in plasma oxidised low density lipoprotein | 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 | For 8 weeks measured every 2 weeks | 
| Change from baseline in plasma fructosamine | 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 | 8 weeks measured every 2 weeks | 
| Change from baseline in plasma glycated albumin | 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 | 8 weeks measured every 2 weeks | 
| Change from baseline in plasma C-reactive protein | 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 | 8 weeks measured every 2 weeks | 
| Change from baseline in plasma Interleukin-6 | 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 | 8 weeks measured every 2 weeks | 
| Change from baseline in plasma Interleukin-1β | 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 | 8 weeks measured every 2 weeks | 
| Change from baseline in plasma Tumor necrosis factor-α | 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 | 8 weeks measured every 2 weeks | 
| Change from baseline in body fat composition percentage | measured using DEXA (Dual-Energy X-ray Absorptiometry) | 8 weeks | 
| Change from baseline in bone mineral density | measured using DEXA (Dual-Energy X-ray Absorptiometry) | 8 weeks | 
| Change from baseline in blood pressure | 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. | 8 weeks measured every 2 weeks | 
| Change from baseline in gut microflora composition | Assessed using gut metagenome and metatranscriptome profiling | 8 weeks measured on days14 and 56 | 
| Change from baseline in gut microflora function | Assessed using gut metagenome and metatranscriptome profiling | 8 weeks measured on days14 and 56 | 
| Change from baseline in Body weight | Body impedance assessments (BIA) | 8 weeks measured every 2 weeks | 
| Change from baseline in segmental % body fat | Body impedance assessments (BIA) | 8 weeks measured every 2 weeks | 
| Change in body circumference measures | Using measuring tape | 8 weeks measured every 2 weeks |