Effect of Butter & MCT Oil on Lipoproteins - A RCT

Hyperlipidemia Clinical Trial

Official title: Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Determine the effects on lipoprotein profiles of high dose concentrated dietary SFA (saturated fatty acids) (from MCT (medium-chain triglyceride) oil + butter) in combination added to coffee. The study will be conducted as a RCT in healthy adults without cardiometabolic disease or conditions that influence lipoprotein metabolism or other specific dietary recommendations.

Clinical Trial Description

Research Design A prospective randomized controlled interventional study

Methodology /Technical Approach A total of up to 60 subjects will be recruited to allow for completion of the study by a minimum of 17 subjects per arm. Subjects will be randomized to one of two groups in a 1:1 ratio. Recruited subjects will be adult coffee drinkers between the ages of 18-45 without hyperlipidemia and without criteria for diabetes or pre-diabetes. Subjects will have baseline weight, waist circumference (WC), and blood-pressure (BP) measurements obtained. Subjects will have baseline fasting lipids,, CMP,HbA1c,TSH,and hsCRP. The subjects will be stratified by gender and randomized to receive one of two dietary regimens: 1) coffee (< 50 kcal of added creamer/sweetener) or 2) coffee with butter + medium-chain triglyceride (MCT) oil combination (2 tbsp. MCT containing 230kcal and 28gm fat+ 2 tbsp butter containing 200kcal and 22gm fat). The drink will be consumed daily over a 4 week period. Dietary history will be evaluated by via the ASA24website (http://appliedresearch.cancer.gov/asa24/). At 6 and 12 weeks post-consent, baseline labs will be repeated. The primary outcome is change in apolipoprotein B between groups. Secondary outcomes include changes in lipids, WC, BP, HbA1c, and FBG. Exploratory analysis will include changes in dietary macronutrient load and subgroup analysis of effects related to dietary patterns.

Primary objective:

1. Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.

Secondary objectives:

1. Evaluating change in:

1. non-HDL-c

2. LDL-c

3. triglycerides

4. BP

5. waist circumference

6. FBG

7. HbA1c

Exploratory objective:

1. Change in macronutrient profiles of dietary patterns.

Our null hypothesis is that the addition of butter and medium-chain triglyceride oil at proposed doses has no clinically significant effects on atherogenic lipoproteins, namely apo lipoprotein B particles (apoB). ;

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

• NCT number: NCT02611102
• Study type: Interventional
• Source: Walter Reed National Military Medical Center
• Status: Completed
• Phase: N/A
• Start date: March 8, 2016
• Completion date: March 2022