Blended Oil Beneficial for Blood Lipids Management

August 19, 2021 updated by: JeyaKumar Henry
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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
For 8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
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
8 weeks measured every 2 weeks
Change from baseline in body fat composition percentage
Time Frame: 8 weeks
measured using DEXA (Dual-Energy X-ray Absorptiometry)
8 weeks
Change from baseline in bone mineral density
Time Frame: 8 weeks
measured using DEXA (Dual-Energy X-ray Absorptiometry)
8 weeks
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.
8 weeks measured every 2 weeks
Change from baseline in gut microflora composition
Time Frame: 8 weeks measured on days14 and 56
Assessed using gut metagenome and metatranscriptome profiling
8 weeks measured on days14 and 56
Change from baseline in gut microflora function
Time Frame: 8 weeks measured on days14 and 56
Assessed using gut metagenome and metatranscriptome profiling
8 weeks measured on days14 and 56
Change from baseline in Body weight
Time Frame: 8 weeks measured every 2 weeks
Body impedance assessments (BIA)
8 weeks measured every 2 weeks
Change from baseline in segmental % body fat
Time Frame: 8 weeks measured every 2 weeks
Body impedance assessments (BIA)
8 weeks measured every 2 weeks
Change in body circumference measures
Time Frame: 8 weeks measured every 2 weeks
Using measuring tape
8 weeks measured every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JeyaKumar Henry

Collaborators

National University, Singapore
Agency for Science, Technology and Research
Wilmar International Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

May 21, 2019

Study Completion (ANTICIPATED)

July 23, 2024

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (ACTUAL)

May 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/00861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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