Cardiovascular Diseases Clinical Trial
Official title:
The Effects of Palm Oil Consumed Under Different Macronutrient Distributions on Circulating Lipoprotein and Fatty Acid Profiles
NCT number | NCT02922062 |
Other study ID # | GRT00038995 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | March 2018 |
Verified date | August 2018 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effects of palm oil when consumed as either part of a low carbohydrate diet or a high carbohydrate diet on blood lipids, cardiovascular health and inflammation. The study will help us better understand how the quality of saturated fat and the quantity of carbohydrate interact to impact blood lipids and cardiovascular health.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - normocholesterolemic Exclusion Criteria: - hypercholesterolemia - diabetes - liver disease - kidney disease - other metabolic or endocrine dysfunction - diagnosis of cancer within the previous 5 years - hypertension - current use of cholesterol reducing medications - current use of diabetic medications |
Country | Name | City | State |
---|---|---|---|
United States | Physical Activity and Education Services (PAES) Building | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | Malaysia Palm Oil Board |
United States,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in C-Reactive Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) | The change in C-Reactive Protein between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in C-Reactive Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) | The change in C-Reactive Protein between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in Interleukin (IL)-1beta Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) | The change in IL-1beta between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in IL-1beta Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) | The change in IL-1beta between Canola Oil and Butter diets will be assessed using a multiplex ELISA platform | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in Tumor Necrosis Factor (TNF)-alpha between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) | The change in TNF-alpha between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in TNF-alpha between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) | The change in TNF-alpha between Canola Oil and Palm Oil will be assessed using a multiplex ELISA platform | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in Neopterin between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) | The change in TNF-alpha between Canola Oil and Palm Oil diets will be assessed using a singleplex ELISA platform | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in Neopterin between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) | The change in Neopterin between Canola Oil and Butter diets will be assessed using a singleplex ELISA platform | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in Elastase between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) | The change in Elastase between Canola Oil and Palm Oil diets will be assessed using a singleplex ELISA platform | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in Elastase between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) | The change in Elastase between Canola Oil and Butter diets will be assessed using a singleplex ELISA platform | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in Conjugated Dienes between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) | The change in Conjugated dienes, an early stage lipid peroxidation product, between Canola Oil and Palm Oil diets will be assessed by spectrophotometry. | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in Conjugated Dienes between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) | The change in Conjugated dienes, an early stage lipid peroxidation product, between Canola Oil and Butter diets will be assessed by spectrophotometry. | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in Malondialdehyde between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) | The change in Malondialdehyde, a late stage lipid peroxidation product, between Canola Oil and Palm Oil diets will be assessed by spectroscopy. | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in Malondialdehyde between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) | The change in Malondialdehyde, a late stage lipid peroxidation product, between Canola Oil and Butter diets will be assessed by high performance liquid chromatography. | Assessed during the 3rd week of the canola oil and butter diets | |
Other | Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) | The change in the total antioxidant capacity of the blood between Canola Oil and Palm Oil diets will be assessed by spectrophotometry using the Ferric Reducing Antioxidant Power (FRAP) assay. | Assessed during the 3rd week of the canola oil and palm oil diets | |
Other | Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) | The change in the total antioxidant capacity of the blood between Canola Oil and Butter diets will be assessed by spectrophotometry using the FRAP assay. | Assessed during the 3rd week of the canola oil and butter diets | |
Primary | Change in High-Density Lipoprotein (HDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) | The change in HDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by Nuclear Magnetic Resonance (NMR) spectroscopy | Assessed during the 3rd week of the canola oil and palm oil diet | |
Primary | Change in HDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution) | The change in HDL particle size and the number of each size particle between Canola Oil and Butter diets will be assessed by Nuclear Magnetic Resonance (NMR) spectroscopy | Assessed during the 3rd week of the canola oil and butter diets | |
Primary | Change in Low-Density Lipoprotein (LDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) | The change in LDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy | Assessed during the 3rd week of the canola oil and palm oil diets | |
Primary | Change in LDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution) | The change in LDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy | Assessed during the 3rd week of the canola oil and butter diets | |
Primary | Change in Very Low-Density Lipoprotein (VLDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) | The change in VLDL particle size and the number of each size particle between Canola Oil and Palm Oil diets will be assessed by NMR spectroscopy | Assessed during the 3rd week of the canola oil and palm oil diets | |
Primary | Change in VLDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution) | The change in VLDL particle size and the number of each size particle between Canola and Butter diets will be assessed by NMR spectroscopy | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in Insulin Sensitivity between the Canola Oil and Palm Oil Diet Phases | The change in glucose and insulin between Canola Oil and Palm Oil diets will be measured from plasma to determine the Homeostasis Model Assessment (HOMA) index score | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in Insulin Sensitivity between the Canola Oil and Butter Diet Phases | The change in glucose and insulin between Canola Oil and Palm Oil diets will be measured from plasma to determine the Homeostasis Model Assessment (HOMA) index score | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in Body Weight between the Canola Oil and Palm Oil Diet Phases | The change in body mass between Canola Oil and Palm Oil diets will be measured on a scale | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in Body Weight between the Canola Oil and Butter Diet Phases | The change in body mass between Canola Oil and Butter diets will be measured on a scale | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in Body Composition (Percent of Lean Mass, Fat Mass and Bone Mass according to the 3-compartment Model) between the Canola Oil and Palm Oil Diet Phases | The change in body composition between Canola Oil and Palm Oil diets will be measured by dual-energy X-ray absorptiometry | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in Body Composition (Percent of Lean Mass, Fat Mass and Bone Mass according to the 3-compartment Model) between the Canola Oil and Butter Diet Phases | The change in body composition between Canola Oil and Butter diets will be measured by dual-energy X-ray absorptiometry | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in the Cholesterol Profile between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) | The change in total cholesterol and HDL cholesterol between Canola Oil and Palm Oil diets will be measured by immunoturbidimetry and LDL cholesterol will be calculated using these two values. | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in the Cholesterol Profile between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) | The change in total cholesterol and HDL cholesterol between Canola Oil and Butter diets will be measured by immunoturbidimetry and LDL cholesterol will be calculated using these two values. | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in Total Triglycerides between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) | The change in triglycerides between Canola Oil and Palm Oil diets will be measured by immunoturbidimetry | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in Total Triglycerides between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) | The change in triglycerides between Canola Oil and Butter diets will be measured by immunoturbidimetry | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) | The change in Apolopoprotein-A1 between Canola Oil and Palm Oil diets will be assessed by ELISA | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) | The change in Apolopoprotein-A1 between Canola Oil and Butter diets will be assessed by ELISA | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) | The change in Apolopoprotein-B between Canola Oil and Palm Oil diets will be assessed by ELISA | Assessed during the 3rd week of the canola oil and Palm Oil diets | |
Secondary | Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) | The change in Apolopoprotein-B between Canola Oil and Butter Diets will be assessed by ELISA | Assessed during the 3rd week of the canola oil and butter diets | |
Secondary | Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Palm Oil Diet Phases | Teh change in the fatty acid composition of the plasma between Canola Oil and Palm Oil diets will be assessed by gas chromatography using flame ionization detection | Assessed during the 3rd week of the canola oil and palm oil diets | |
Secondary | Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Butter Diet Phases | The change in the fatty acid composition of the plasma between Canola Oil and Butter will be assessed by gas chromatography using flame ionization detection | Assessed during the 3rd week of the canola oil and butter diets |
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