The Effects of Consuming Palm Oil With Different Macronutrient Intakes on Blood Lipids

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Palm Oil Consumed Under Different Macronutrient Distributions on Circulating Lipoprotein and Fatty Acid Profiles

Conditions
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Cardiovascular Diseases, Inflammation

Intervention / Treatment
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* Other: Canola Oil
* Other: Palm Oil
* Other: Butter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Carbohydrate Diet<br>Half of the participants will be randomly assigned to this diet arm. The macronutrient composition of the diet will be (PRO (protein):CHO (carbohydrate):FAT, 18:8:74). There are three diet phases within this arm that use different fats as the primary cooking oil either canola oil, palm oil or butter. Each diet phase lasts for 3 weeks. At the end of each diet phase the testing battery completed at baseline will be repeated followed by a 2 week washout where subjects revert back to their usual diets. Canola oil is the low saturated fat control diet and is administered first. Participants then randomly begin either the palm oil or canola oil diet phases. | Other: Canola Oil<br>* Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be canola oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.<br>* Other names: Controlled Dietary Intervention using Canola Oil;Other: Palm Oil<br>* Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be palm oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.<br>* Other names: Controlled Dietary Intervention using Palm Oil;Other: Butter<br>* Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oils used in food preparation will be butter. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.<br>* Other names: Controlled Dietary Intervention using Butter;|
| Active Comparator: High Carbohydrate Diet<br>Half of the participants will be randomly assigned to this diet arm. The macronutrient composition of the diet will be (PRO:CHO:FAT, 18:60:22). There are three diet phases within this arm that use different fats as the primary cooking oil either canola oil, palm oil or butter. Each diet phase lasts for 3 weeks. At the end of each diet phase the testing battery completed at baseline will be repeated followed by a 2 week washout where subjects revert back to their usual diets. Canola oil is the low saturated fat control diet and is administered first. Participants then randomly begin either the palm oil or canola oil diet phases. | Other: Canola Oil<br>* Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be canola oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.<br>* Other names: Controlled Dietary Intervention using Canola Oil;Other: Palm Oil<br>* Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be palm oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.<br>* Other names: Controlled Dietary Intervention using Palm Oil;Other: Butter<br>* Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oils used in food preparation will be butter. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.<br>* Other names: Controlled Dietary Intervention using Butter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipids, saturated fat, palm oil