Clinical trial NCT02922062: The Effects of Consuming Palm Oil With Different Macronutrient Intakes on Blood Lipids
Official title: The Effects of Palm Oil Consumed Under Different Macronutrient Distributions on Circulating Lipoprotein and Fatty Acid Profiles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Inflammation
Keywords: lipids
saturated fat
palm oil
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Malaysia Palm Oil Board
First posted: 2016-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: The purpose of this study is to determine the effects of palm oil on blood lipids, cardiovascular health and inflammation. Potential subjects will be screened until 24 qualifying healthy participants are enrolled. After enrollment participants will undergo a baseline battery of tests including blood draws, body composition, measures of height and weight, blood lipid profile (cholesterol, lipoprotein particle size, quantity and fatty acid composition), insulin sensitivity using a static index, inflammation, antioxidant status and measurement of energy expenditure and substrate oxidation by indirect calorimetry. Participants will be randomly divided into one of two arms/tracks, either a low carbohydrate diet arm or a high carbohydrate diet arm. Each diet arm consists of 3 phases a low saturated fat control diet where the primary cooking oil is canola oil and two saturated fat diet phases where the primary cooking oil is either palm oil or butter.

Participants will begin with the low saturated fat diet phase first which consists of 50% of fat calories derived from canola oil for 3 weeks. At the end of this control diet phase the battery of tests completed at baseline will be repeated. After a 2-week washout period participants will then proceed in random order into either the palm oil or butter diet phases of their diet arm/track. The palm oil and butter diet phases are also 3 weeks in duration and separated by a 2 week washout period. The palm oil and butter diet phases will derive 50% of the fat calories from either palm oil or butter. Both oils are high in saturated fat but differ in the quality of saturated fat. At the end of each diet phase the testing battery completed at baseline will be repeated. The subjects will never be exposed to more than minimal risk and in return will receive 9 weeks of food, individualized reports of their study results and a monetary stipend. 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. This knowledge can be used to aid dietary recommendations for cardiovascular health and control of blood lipids.

Eligibility criteria: 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

Primary outcomes:
measure: Change in High-Density Lipoprotein (HDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diet
measure: Change in HDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Low-Density Lipoprotein (LDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in LDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Very Low-Density Lipoprotein (VLDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in VLDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
Secondary outcomes:
measure: Change in Insulin Sensitivity between the Canola Oil and Palm Oil Diet Phases
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Insulin Sensitivity between the Canola Oil and Butter Diet Phases
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Body Weight between the Canola Oil and Palm Oil Diet Phases
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Body Weight between the Canola Oil and Butter Diet Phases
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: 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
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: 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
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in the Cholesterol Profile between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in the Cholesterol Profile between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Total Triglycerides between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Total Triglycerides between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and Palm Oil diets
measure: Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Palm Oil Diet Phases
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Butter Diet Phases
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
Other outcomes:
measure: Change in C-Reactive Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in C-Reactive Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Interleukin (IL)-1beta Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in IL-1beta Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Tumor Necrosis Factor (TNF)-alpha between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in TNF-alpha between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Neopterin between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Neopterin between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Elastase between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Elastase between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Conjugated Dienes between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Conjugated Dienes between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in Malondialdehyde between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in Malondialdehyde between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
measure: Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment)
timeFrame: Assessed during the 3rd week of the canola oil and palm oil diets
measure: Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment)
timeFrame: Assessed during the 3rd week of the canola oil and butter diets
Locations:
city: Columbus
country: United States
facility: Physical Activity and Education Services (PAES) Building
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeff S Volek, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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