Clinical trial NCT02611102: Effect of Butter & MCT Oil on Lipoproteins - A RCT
Official title: Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Keywords: cardiovascular disease/medium-chain-triglycerides/cholesterol
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2015-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Eligibility 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

Primary outcomes:
measure: Changes in apolipoprotein B
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: non-HDL-c
timeFrame: 6 weeks
measure: LDL-c
timeFrame: 6 weeks
measure: triglycerides
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
measure: waist circumference
timeFrame: 6 weeks
measure: Fasting Blood Glucose
timeFrame: 6 weeks
measure: HbA1c
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: WRNMMC
name: Thanh D Hoang, DO
role: PRINCIPAL_INVESTIGATOR
References: