Blended Oil Beneficial for Blood Lipids Management

Hyperlipidemias Clinical Trial

Official title:

Blended Oil Beneficial for Blood Lipids Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03964857
• Other study ID #: 2018/00861
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 23, 2024

Study information

• Verified date: August 2021
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 23, 2024
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Other:
• Refined olive oil (ROO)
Consumption of chicken dishes made with ROO for a period of 8 weeks
• Blended Oil 1 (BO1)
Consumption of chicken dishes made with BO1 for a period of 8 weeks
• Blended Oil 2 (BO2)
Consumption of chicken dishes made with BO2 for a period of 8 weeks

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
JeyaKumar Henry	Agency for Science, Technology and Research, National University, Singapore, Wilmar International Limited

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	8 weeks measured every 2 weeks
Secondary	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	8 weeks measured every 2 weeks
Secondary	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	For 8 weeks measured every 2 weeks
Secondary	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	8 weeks measured every 2 weeks
Secondary	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	8 weeks measured every 2 weeks
Secondary	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	8 weeks measured every 2 weeks
Secondary	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	8 weeks measured every 2 weeks
Secondary	Change from baseline in plasma Interleukin-1ß	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
Secondary	Change from baseline in plasma Tumor necrosis factor-a	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
Secondary	Change from baseline in body fat composition percentage	measured using DEXA (Dual-Energy X-ray Absorptiometry)	8 weeks
Secondary	Change from baseline in bone mineral density	measured using DEXA (Dual-Energy X-ray Absorptiometry)	8 weeks
Secondary	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.	8 weeks measured every 2 weeks
Secondary	Change from baseline in gut microflora composition	Assessed using gut metagenome and metatranscriptome profiling	8 weeks measured on days14 and 56
Secondary	Change from baseline in gut microflora function	Assessed using gut metagenome and metatranscriptome profiling	8 weeks measured on days14 and 56
Secondary	Change from baseline in Body weight	Body impedance assessments (BIA)	8 weeks measured every 2 weeks
Secondary	Change from baseline in segmental % body fat	Body impedance assessments (BIA)	8 weeks measured every 2 weeks
Secondary	Change in body circumference measures	Using measuring tape	8 weeks measured every 2 weeks