Blended Oil Beneficial for Blood Lipids Management

NCT ID: NCT03964857

Last Updated: 2021-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2024-07-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Refined olive oil (ROO)

Control

Group Type OTHER

Refined olive oil (ROO)

Intervention Type OTHER

Consumption of chicken dishes made with ROO for a period of 8 weeks

Blended Oil 1

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

Group Type EXPERIMENTAL

Blended Oil 1 (BO1)

Intervention Type OTHER

Consumption of chicken dishes made with BO1 for a period of 8 weeks

Blended Oil 2

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

Group Type EXPERIMENTAL

Blended Oil 2 (BO2)

Intervention Type OTHER

Consumption of chicken dishes made with BO2 for a period of 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Refined olive oil (ROO)

Consumption of chicken dishes made with ROO for a period of 8 weeks

Intervention Type OTHER

Blended Oil 1 (BO1)

Consumption of chicken dishes made with BO1 for a period of 8 weeks

Intervention Type OTHER

Blended Oil 2 (BO2)

Consumption of chicken dishes made with BO2 for a period of 8 weeks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wilmar International Limited

UNKNOWN

Sponsor Role collaborator

National University of Singapore

OTHER

Sponsor Role collaborator

Agency for Science, Technology and Research

OTHER

Sponsor Role collaborator

JeyaKumar Henry

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JeyaKumar Henry

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Nutrition Research Centre

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35548564 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33188423 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/00861

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nuts and Oil Pilot Study
NCT04361617 COMPLETED NA