Blended Oil Beneficial for Blood Lipids Management

JeyaKumar Henry

Status: Active, not recruiting

Conditions: Hyperlipidemias

Treatments: Other: Blended Oil 1 (BO1); Other: Blended Oil 2 (BO2); Other: Refined olive oil (ROO)

Study type: Interventional

Funder types: Other

Identifiers

NCT03964857

2018/00861

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Refined olive oil (ROO)

Other group

Description:

Control

Treatment:

Other: Refined olive oil (ROO)

Blended Oil 1

Experimental group

Description:

BO1, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 2

Treatment:

Other: Blended Oil 1 (BO1)

Blended Oil 2

Experimental group

Description:

BO2, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 1

Treatment:

Other: Blended Oil 2 (BO2)