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

NCT02922062 | Completed

• 1 other identifier: GRT00038995
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Inflammation

Keywords

lipids; saturated fat; palm oil

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (16)

• Change in Insulin Sensitivity between the Canola Oil and Palm Oil Diet Phases

  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

  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

  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

  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

  Assessed during the 3rd week of the canola oil and palm oil diets

Other Outcomes (16)

• Change in C-Reactive Protein between the Canola Oil and Palm Oil Diet Phases (Part of an Inflammatory Panel)

  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)

  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)

  Assessed during the 3rd week of the canola oil and palm oil diets

Study Arms (2)

Low Carbohydrate Diet

EXPERIMENTAL

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; Other: Palm Oil; Other: Butter

High Carbohydrate Diet

ACTIVE COMPARATOR

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; Other: Palm Oil; Other: Butter

Interventions

Canola Oil OTHER

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.

Also known as: low saturated fat control, Controlled Dietary Intervention using Canola Oil

High Carbohydrate Diet; Low Carbohydrate Diet

Palm Oil OTHER

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.

Also known as: saturated fat, Controlled Dietary Intervention using Palm Oil

High Carbohydrate Diet; Low Carbohydrate Diet

Butter OTHER

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.

Also known as: saturated fat, Controlled Dietary Intervention using Butter

High Carbohydrate Diet; Low Carbohydrate Diet

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• normocholesterolemic

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Malaysia Palm Oil Board: collaborator

Study Sites (1)

Physical Activity and Education Services (PAES) Building

Columbus, Ohio, 43210, United States

Location

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MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Rapeseed Oil; Palm Oil; Fatty Acids; Butter

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Dietary Fats; Fats; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jeff S Volek, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: October 3, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)