Effect of Butter & MCT Oil on Lipoproteins - A RCT
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

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.
    

Detailed 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).
    

Intervention name(s): MCT oil + Butter in Coffee
Intervention type(s): Dietary Supplement
Intervention description(s): 2 tablespoons medium-chain triglyceride oil + 2 tablespoons butter added to 2-4 cups of coffee similar to their usual intake prior to 1200 daily over a 4 week period after a 2 week run-in phase during which the doses of butter and MCT oil will be titrated up (1 Tbsp. of each butter + MCT x 5 days, 2 Tbsp. butter + 1 Tbsp. MCT x 5 days, then 2 Tbsp. of each x 4 days) followed by 6 weeks of washout without treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cardiovascular disease/medium-chain-triglycerides/cholesterol