Blended Oil Beneficial for Blood Lipids Management
- Conditions
- Hyperlipidemias
- Interventions
- Other: Refined olive oil (ROO)Other: Blended Oil 1 (BO1)Other: Blended Oil 2 (BO2)
- Registration Number
- NCT03964857
- Lead Sponsor
- JeyaKumar Henry
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Male and post-menopausal female,
- Chinese ethnicity
- Age ≥50 and ≤70 years
- LDL cholesterol (measured) ≥3.06 mmol/l and ≤4.51 mmol/l
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Refined olive oil (ROO) Refined olive oil (ROO) Control Blended Oil 1 Blended Oil 1 (BO1) BO1, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 2 Blended Oil 2 Blended Oil 2 (BO2) BO2, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 1
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 bone mineral density 8 weeks measured using DEXA (Dual-Energy X-ray Absorptiometry)
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 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 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 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 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
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 body fat composition percentage 8 weeks measured using DEXA (Dual-Energy X-ray Absorptiometry)
Change from baseline in segmental % body fat 8 weeks measured every 2 weeks Body impedance assessments (BIA)
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 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 gut microflora composition 8 weeks measured on days14 and 56 Assessed using gut metagenome and metatranscriptome profiling
Change in body circumference measures 8 weeks measured every 2 weeks Using measuring tape
Trial Locations
- Locations (1)
Clinical Nutrition Research Centre
🇸🇬Singapore, Singapore