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

The Ohio State University

Status: Completed

Conditions: Inflammation; Cardiovascular Diseases

Treatments: Other: Butter; Other: Palm Oil; Other: Canola Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02922062

GRT00038995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Low Carbohydrate Diet

Experimental group

Description:

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.

Treatment:

Other: Palm Oil

Other: Canola Oil

Other: Butter

High Carbohydrate Diet

Active Comparator group

Description:

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.

Treatment:

Other: Palm Oil

Other: Canola Oil

Other: Butter