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Blended Oil Beneficial for Blood Lipids Management

Primary Purpose

Hyperlipidemias

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Refined olive oil (ROO)
Blended Oil 1 (BO1)
Blended Oil 2 (BO2)
Sponsored by
JeyaKumar Henry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperlipidemias

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Refined olive oil (ROO)

Blended Oil 1

Blended Oil 2

Arm Description

Control

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

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
Change from baseline in body fat composition percentage
measured using DEXA (Dual-Energy X-ray Absorptiometry)
Change from baseline in bone mineral density
measured using DEXA (Dual-Energy X-ray Absorptiometry)
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.
Change from baseline in gut microflora composition
Assessed using gut metagenome and metatranscriptome profiling
Change from baseline in gut microflora function
Assessed using gut metagenome and metatranscriptome profiling
Change from baseline in Body weight
Body impedance assessments (BIA)
Change from baseline in segmental % body fat
Body impedance assessments (BIA)
Change in body circumference measures
Using measuring tape

Full Information

First Posted
May 15, 2019
Last Updated
August 19, 2021
Sponsor
JeyaKumar Henry
Collaborators
Wilmar International Limited, National University of Singapore, Agency for Science, Technology and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03964857
Brief Title
Blended Oil Beneficial for Blood Lipids Management
Official Title
Blended Oil Beneficial for Blood Lipids Management
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 21, 2019 (Actual)
Study Completion Date
July 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JeyaKumar Henry
Collaborators
Wilmar International Limited, National University of Singapore, Agency for Science, Technology and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Refined olive oil (ROO)
Arm Type
Other
Arm Description
Control
Arm Title
Blended Oil 1
Arm Type
Experimental
Arm Description
BO1, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 2
Arm Title
Blended Oil 2
Arm Type
Experimental
Arm Description
BO2, propriety blend of cooking oil containing rice bran, flaxseed and sesame oil blended at proportions different from 'Blended Oil 1
Intervention Type
Other
Intervention Name(s)
Refined olive oil (ROO)
Intervention Description
Consumption of chicken dishes made with ROO for a period of 8 weeks
Intervention Type
Other
Intervention Name(s)
Blended Oil 1 (BO1)
Intervention Description
Consumption of chicken dishes made with BO1 for a period of 8 weeks
Intervention Type
Other
Intervention Name(s)
Blended Oil 2 (BO2)
Intervention Description
Consumption of chicken dishes made with BO2 for a period of 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline serum total cholesterol
Description
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline serum low density lipoprotein cholesterol
Description
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline serum total high density lipoprotein cholesterol
Description
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline serum total triglycerides
Description
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Time Frame
8 weeks measured every 2 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of serum glucose
Description
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline of serum insulin
Description
Blood will be collected in plain serum tubes after an overnight fast, centrifuged and frozen within 2 hours of collection
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in plasma oxidised low density lipoprotein
Description
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
Time Frame
For 8 weeks measured every 2 weeks
Title
Change from baseline in plasma fructosamine
Description
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
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in plasma glycated albumin
Description
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
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in plasma C-reactive protein
Description
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
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in plasma Interleukin-6
Description
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
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in plasma Interleukin-1β
Description
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
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in plasma Tumor necrosis factor-α
Description
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
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in body fat composition percentage
Description
measured using DEXA (Dual-Energy X-ray Absorptiometry)
Time Frame
8 weeks
Title
Change from baseline in bone mineral density
Description
measured using DEXA (Dual-Energy X-ray Absorptiometry)
Time Frame
8 weeks
Title
Change from baseline in blood pressure
Description
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.
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in gut microflora composition
Description
Assessed using gut metagenome and metatranscriptome profiling
Time Frame
8 weeks measured on days14 and 56
Title
Change from baseline in gut microflora function
Description
Assessed using gut metagenome and metatranscriptome profiling
Time Frame
8 weeks measured on days14 and 56
Title
Change from baseline in Body weight
Description
Body impedance assessments (BIA)
Time Frame
8 weeks measured every 2 weeks
Title
Change from baseline in segmental % body fat
Description
Body impedance assessments (BIA)
Time Frame
8 weeks measured every 2 weeks
Title
Change in body circumference measures
Description
Using measuring tape
Time Frame
8 weeks measured every 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35548564
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.
Results Reference
derived
PubMed Identifier
33188423
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.
Results Reference
derived

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Blended Oil Beneficial for Blood Lipids Management

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