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Blended Oil Beneficial for Blood Lipids Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964857
Recruitment Status : Active, not recruiting
First Posted : May 28, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborators:
Wilmar International Limited
National University, Singapore
Agency for Science, Technology and Research
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

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

Condition or disease Intervention/treatment Phase
Hyperlipidemias Other: Refined olive oil (ROO) Other: Blended Oil 1 (BO1) Other: Blended Oil 2 (BO2) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Blended Oil Beneficial for Blood Lipids Management
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
Refined olive oil (ROO)
Control
Other: Refined olive oil (ROO)
Consumption of chicken dishes made with ROO for a period of 8 weeks

Experimental: Blended Oil 1
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)
Consumption of chicken dishes made with BO1 for a period of 8 weeks

Experimental: Blended Oil 2
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)
Consumption of chicken dishes made with BO2 for a period of 8 weeks




Primary Outcome Measures :
  1. Change from baseline serum total cholesterol [ Time Frame: 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

  2. Change from baseline serum low density lipoprotein cholesterol [ Time Frame: 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

  3. Change from baseline serum total high density lipoprotein cholesterol [ Time Frame: 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

  4. Change from baseline serum total triglycerides [ Time Frame: 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 :
  1. Change from baseline of serum glucose [ Time Frame: 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

  2. Change from baseline of serum insulin [ Time Frame: 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

  3. Change from baseline in plasma oxidised low density lipoprotein [ Time Frame: 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

  4. Change from baseline in plasma fructosamine [ Time Frame: 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

  5. Change from baseline in plasma glycated albumin [ Time Frame: 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

  6. Change from baseline in plasma C-reactive protein [ Time Frame: 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

  7. Change from baseline in plasma Interleukin-6 [ Time Frame: 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

  8. Change from baseline in plasma Interleukin-1β [ Time Frame: 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

  9. Change from baseline in plasma Tumor necrosis factor-α [ Time Frame: 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

  10. Change from baseline in body fat composition percentage [ Time Frame: 8 weeks ]
    measured using DEXA (Dual-Energy X-ray Absorptiometry)

  11. Change from baseline in bone mineral density [ Time Frame: 8 weeks ]
    measured using DEXA (Dual-Energy X-ray Absorptiometry)

  12. Change from baseline in blood pressure [ Time Frame: 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.

  13. Change from baseline in gut microflora composition [ Time Frame: 8 weeks measured on days14 and 56 ]
    Assessed using gut metagenome and metatranscriptome profiling

  14. Change from baseline in gut microflora function [ Time Frame: 8 weeks measured on days14 and 56 ]
    Assessed using gut metagenome and metatranscriptome profiling

  15. Change from baseline in Body weight [ Time Frame: 8 weeks measured every 2 weeks ]
    Body impedance assessments (BIA)

  16. Change from baseline in segmental % body fat [ Time Frame: 8 weeks measured every 2 weeks ]
    Body impedance assessments (BIA)

  17. Change in body circumference measures [ Time Frame: 8 weeks measured every 2 weeks ]
    Using measuring tape



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964857


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
JeyaKumar Henry
Wilmar International Limited
National University, Singapore
Agency for Science, Technology and Research
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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03964857    
Other Study ID Numbers: 2018/00861
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases