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

August 21, 2018 updated by: Jeff Volek, Ohio State University

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

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.

Study Overview

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

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • Physical Activity and Education Services (PAES) Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.
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
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
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.
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
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
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

What is the study measuring?

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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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.
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)
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.
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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
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
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
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
Assessed during the 3rd week of the canola oil and butter diets

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed during the 3rd week of the canola oil and palm oil diets
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
Assessed during the 3rd week of the canola oil and butter diets
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
Assessed during the 3rd week of the canola oil and palm oil diets
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
Assessed during the 3rd week of the canola oil and butter diets
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
Assessed during the 3rd week of the canola oil and palm oil diets
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
Assessed during the 3rd week of the canola oil and butter diets
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
Assessed during the 3rd week of the canola oil and palm oil diets
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
Assessed during the 3rd week of the canola oil and butter diets
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
Assessed during the 3rd week of the canola oil and palm oil diets
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
Assessed during the 3rd week of the canola oil and butter diets
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.
Assessed during the 3rd week of the canola oil and palm oil diets
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.
Assessed during the 3rd week of the canola oil and butter diets
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.
Assessed during the 3rd week of the canola oil and palm oil diets
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.
Assessed during the 3rd week of the canola oil and butter diets
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.
Assessed during the 3rd week of the canola oil and palm oil diets
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.
Assessed during the 3rd week of the canola oil and butter diets

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jeff S Volek, Ph.D., Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • GRT00038995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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