Blended Oil Beneficial for Blood Lipids Management

NCT03964857 | Unknown

• 1 other identifier: 2018/00861
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (4)

• 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

  8 weeks measured every 2 weeks

• 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

  8 weeks measured every 2 weeks

• 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

  8 weeks measured every 2 weeks

• 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

  8 weeks measured every 2 weeks

Secondary Outcomes (17)

• Change from baseline of serum glucose

  8 weeks measured every 2 weeks

• Change from baseline of serum insulin

  8 weeks measured every 2 weeks

• Change from baseline in plasma oxidised low density lipoprotein

  For 8 weeks measured every 2 weeks

• Change from baseline in plasma fructosamine

  8 weeks measured every 2 weeks

• Change from baseline in plasma glycated albumin

  8 weeks measured every 2 weeks

Study Arms (3)

Refined olive oil (ROO)

OTHER

Control

Other: Refined olive oil (ROO)

Blended Oil 1

EXPERIMENTAL

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)

Blended Oil 2

EXPERIMENTAL

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)

Interventions

Refined olive oil (ROO) OTHER

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

Refined olive oil (ROO)

Blended Oil 1 (BO1) OTHER

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

Blended Oil 1

Blended Oil 2 (BO2) OTHER

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

Blended Oil 2

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and post-menopausal female,
• Chinese ethnicity
• Age ≥50 and ≤70 years
• LDL cholesterol (measured) ≥3.06 mmol/l and ≤4.51 mmol/l

You may not qualify if:

• 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

Sponsors & Collaborators

• JeyaKumar Henry: lead
• Wilmar International Limited: collaborator
• National University of Singapore: collaborator
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

Related Publications (2)

• 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.

  PMID: 35548564 DERIVED

• 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.

  PMID: 33188423 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 28, 2019
• Study Start: November 1, 2018
• Primary Completion: May 21, 2019
• Study Completion: July 23, 2024
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)