Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
MCT oil + Butter in Coffee
Cardiovascular Diseases+3
+ Hyperlipidemias
+ Metabolic Diseases
Prevention Study
Summary
Study start date: March 8, 2016
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. DoD healthcare beneficiaries 2. willing to drink 2 to 4 cups of coffee daily 3. between the ages of 18 to 45 4. serum LDL-c \< 160, 5. non-HDL-c \< 190 6. apoB \< 120 Exclusion Criteria: 1. BMI \> 30kg/m2 or \< 20kg/m2 or waist circumference \> 102cm (males) or 88cm (females) 2. Triglycerides \> 150 3. Hypertension defined as SBP \> 150, DBP \> 90 or on treatment for high blood pressure 4. Chronic liver disease defined by any clinical or a history of serum AST or ALT \> 3 times ULN 5. Kidney disease defined as a GFR \<90 ml/min or history of nephritic syndrome 6. Impaired glucose metabolism defined as HbA1c \> 5.6, FBG \> 99, or 2-hour OGTT \> 139 7. Any known malignancy 8. Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass 9. Hypothyroidism per lab evaluation at baseline 10. Pregnancy 11. Polycystic Ovary Syndrome or irregular menstrual periods 12. Subjects taking certain medications such as glucocorticoids, immunosuppressants (cyclosporine, sirolimus, etc.), tamoxifen, androgens, antipsychotics, hydrochlorothiazide, retinoids, beta-blockers, statins, bile acid sequestrants, niacin, fibrates, ezetimibe, high dose fish oil (\>1gm/day epa + dha), or any other supplement or pharmacologic agent known to alter lipoproteins a. If on hormonal contraceptives, lipid panel must be stable over the past 12-24 months 13. Cushing's syndrome per medical history or clinical suspicion 14. HIV per medical history 15. Chronic Inflammatory Disorders such as, but not limited to, SLE, RA, IBD per medical history 16. History of tobacco use within the previous 12 months to include cigarettes, e-cigarettes, chewing tobacco, cigars, and pipes. 17. History of marijuana use within the previous 12 months 18. Active intentional weight loss of over 5% in the past 3 months
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Walter Reed National Military Medical Center
Bethesda, United StatesOpen Walter Reed National Military Medical Center in Google Maps