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

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ClinicalTrials.gov Identifier: NCT02922062
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Malaysia Palm Oil Board
Information provided by (Responsible Party):
Jeff Volek, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Inflammation Other: Canola Oil Other: Palm Oil Other: Butter Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Palm Oil Consumed Under Different Macronutrient Distributions on Circulating Lipoprotein and Fatty Acid Profiles
Actual Study Start Date : November 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Carbohydrate Diet
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
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.
Other Names:
  • low saturated fat control
  • Controlled Dietary Intervention using Canola Oil

Other: Palm Oil
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.
Other Names:
  • saturated fat
  • Controlled Dietary Intervention using Palm Oil

Other: Butter
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.
Other Names:
  • saturated fat
  • Controlled Dietary Intervention using Butter

Active Comparator: High Carbohydrate Diet
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
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.
Other Names:
  • low saturated fat control
  • Controlled Dietary Intervention using Canola Oil

Other: Palm Oil
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.
Other Names:
  • saturated fat
  • Controlled Dietary Intervention using Palm Oil

Other: Butter
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.
Other Names:
  • saturated fat
  • Controlled Dietary Intervention using Butter




Primary Outcome Measures :
  1. Change in High-Density Lipoprotein (HDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diet ]
    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

  2. Change in HDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    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

  3. Change in Low-Density Lipoprotein (LDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    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

  4. Change in LDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    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

  5. Change in Very Low-Density Lipoprotein (VLDL) Particle Size between Canola Oil and Palm Oil Diet Phases (Part of the Lipoprotein Distribution) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    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

  6. Change in VLDL Particle Size between Canola Oil and Butter Diet Phases (Part of the Lipoprotein Distribution) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in VLDL particle size and the number of each size particle between Canola and Butter diets will be assessed by NMR spectroscopy


Secondary Outcome Measures :
  1. Change in Insulin Sensitivity between the Canola Oil and Palm Oil Diet Phases [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    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

  2. Change in Insulin Sensitivity between the Canola Oil and Butter Diet Phases [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    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

  3. Change in Body Weight between the Canola Oil and Palm Oil Diet Phases [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in body mass between Canola Oil and Palm Oil diets will be measured on a scale

  4. Change in Body Weight between the Canola Oil and Butter Diet Phases [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in body mass between Canola Oil and Butter diets will be measured on a scale

  5. 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 [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in body composition between Canola Oil and Palm Oil diets will be measured by dual-energy X-ray absorptiometry

  6. 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 [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in body composition between Canola Oil and Butter diets will be measured by dual-energy X-ray absorptiometry

  7. Change in the Cholesterol Profile between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    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.

  8. Change in the Cholesterol Profile between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    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.

  9. Change in Total Triglycerides between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in triglycerides between Canola Oil and Palm Oil diets will be measured by immunoturbidimetry

  10. Change in Total Triglycerides between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in triglycerides between Canola Oil and Butter diets will be measured by immunoturbidimetry

  11. Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in Apolopoprotein-A1 between Canola Oil and Palm Oil diets will be assessed by ELISA

  12. Change in the Apolopoprotein-A1 Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in Apolopoprotein-A1 between Canola Oil and Butter diets will be assessed by ELISA

  13. Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Palm Oil Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and Palm Oil diets ]
    The change in Apolopoprotein-B between Canola Oil and Palm Oil diets will be assessed by ELISA

  14. Change in the Apolopoprotein-B Concentration in plasma between the Canola Oil and Butter Diet Phases (Part of the Cholesterol Profile) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in Apolopoprotein-B between Canola Oil and Butter Diets will be assessed by ELISA

  15. Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Palm Oil Diet Phases [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    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

  16. Change in the Fatty Acid Composition of the Plasma between the Canola Oil and Butter Diet Phases [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    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


Other Outcome Measures:
  1. Change in C-Reactive Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in C-Reactive Protein between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform

  2. Change in C-Reactive Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in C-Reactive Protein between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform

  3. Change in Interleukin (IL)-1beta Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in IL-1beta between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform

  4. Change in IL-1beta Protein between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in IL-1beta between Canola Oil and Butter diets will be assessed using a multiplex ELISA platform

  5. Change in Tumor Necrosis Factor (TNF)-alpha between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in TNF-alpha between Canola Oil and Palm Oil diets will be assessed using a multiplex ELISA platform

  6. Change in TNF-alpha between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in TNF-alpha between Canola Oil and Palm Oil will be assessed using a multiplex ELISA platform

  7. Change in Neopterin between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in TNF-alpha between Canola Oil and Palm Oil diets will be assessed using a singleplex ELISA platform

  8. Change in Neopterin between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in Neopterin between Canola Oil and Butter diets will be assessed using a singleplex ELISA platform

  9. Change in Elastase between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in Elastase between Canola Oil and Palm Oil diets will be assessed using a singleplex ELISA platform

  10. Change in Elastase between the Canola Oil and Butter Diet Phases (Part of an Inflammatory Panel) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in Elastase between Canola Oil and Butter diets will be assessed using a singleplex ELISA platform

  11. Change in Conjugated Dienes between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in Conjugated dienes, an early stage lipid peroxidation product, between Canola Oil and Palm Oil diets will be assessed by spectrophotometry.

  12. Change in Conjugated Dienes between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in Conjugated dienes, an early stage lipid peroxidation product, between Canola Oil and Butter diets will be assessed by spectrophotometry.

  13. Change in Malondialdehyde between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    The change in Malondialdehyde, a late stage lipid peroxidation product, between Canola Oil and Palm Oil diets will be assessed by spectroscopy.

  14. Change in Malondialdehyde between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    The change in Malondialdehyde, a late stage lipid peroxidation product, between Canola Oil and Butter diets will be assessed by high performance liquid chromatography.

  15. Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Palm Oil Diet Phases (Part of an Antioxidant Status Assessment) [ Time Frame: Assessed during the 3rd week of the canola oil and palm oil diets ]
    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.

  16. Change in the Total Antioxidant Capacity of the blood between the Canola Oil and Butter Diet Phases (Part of an Antioxidant Status Assessment) [ Time Frame: Assessed during the 3rd week of the canola oil and butter diets ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922062


Locations
United States, Ohio
Physical Activity and Education Services (PAES) Building
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Malaysia Palm Oil Board
Investigators
Principal Investigator: Jeff S Volek, Ph.D. Ohio State University

Publications:

Responsible Party: Jeff Volek, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02922062     History of Changes
Other Study ID Numbers: GRT00038995
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with other scientists but participants will be provided with their own individual data when the study is complete.

Keywords provided by Jeff Volek, Ohio State University:
lipids
saturated fat
palm oil

Additional relevant MeSH terms:
Inflammation
Cardiovascular Diseases
Pathologic Processes