Clinical trial NCT03964857: Blended Oil Beneficial for Blood Lipids Management
Official title: Blended Oil Beneficial for Blood Lipids Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemias
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Wilmar International Limited
name: National University of Singapore
name: Agency for Science, Technology and Research
First posted: 2019-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline serum total cholesterol
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline serum low density lipoprotein cholesterol
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline serum total high density lipoprotein cholesterol
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline serum total triglycerides
timeFrame: 8 weeks measured every 2 weeks
Secondary outcomes:
measure: Change from baseline of serum glucose
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline of serum insulin
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in plasma oxidised low density lipoprotein
timeFrame: For 8 weeks measured every 2 weeks
measure: Change from baseline in plasma fructosamine
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in plasma glycated albumin
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in plasma C-reactive protein
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in plasma Interleukin-6
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in plasma Interleukin-1β
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in plasma Tumor necrosis factor-α
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in body fat composition percentage
timeFrame: 8 weeks
measure: Change from baseline in bone mineral density
timeFrame: 8 weeks
measure: Change from baseline in blood pressure
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in gut microflora composition
timeFrame: 8 weeks measured on days14 and 56
measure: Change from baseline in gut microflora function
timeFrame: 8 weeks measured on days14 and 56
measure: Change from baseline in Body weight
timeFrame: 8 weeks measured every 2 weeks
measure: Change from baseline in segmental % body fat
timeFrame: 8 weeks measured every 2 weeks
measure: Change in body circumference measures
timeFrame: 8 weeks measured every 2 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References:
citation: Haldar S, Ponnalagu S, Osman F, Tay SL, Wong LH, Jiang YR, Leow MKS, Henry CJ. Increased Consumption of Unsaturated Fatty Acids Improves Body Composition in a Hypercholesterolemic Chinese Population. Front Nutr. 2022 Apr 25;9:869351. doi: 10.3389/fnut.2022.869351. eCollection 2022.
citation: Haldar S, Wong LH, Tay SL, Jacoby JJ, He P, Osman F, Ponnalagu S, Jiang YR, Lian HPR, Henry CJ. Two Blends of Refined Rice Bran, Flaxseed, and Sesame Seed Oils Affect the Blood Lipid Profile of Chinese Adults with Borderline Hypercholesterolemia to a Similar Extent as Refined Olive Oil. J Nutr. 2020 Dec 10;150(12):3141-3151. doi: 10.1093/jn/nxaa274.