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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611102
• Other study ID #: 404482-2
• Status: Completed
• Phase: N/A
• Start date: March 8, 2016
• Est. completion date: March 2022

Study information

• Verified date: April 2023
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• MCT oil + Butter in Coffee
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.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in apolipoprotein B	Evaluate clinically and statistically significant changes of apoB number in healthy adults who consume coffee with butter and MCT oil.	Baseline and 6 weeks
Secondary	non-HDL-c	Evaluating change in non-HDL_c	6 weeks
Secondary	LDL-c	Evaluating change in LDL-c	6 weeks
Secondary	triglycerides	Evaluating change in triglycerides	6 weeks
Secondary	Blood pressure	Evaluating change in blood pressure	6 weeks
Secondary	waist circumference	Evaluating change in waist circumference	6 weeks
Secondary	Fasting Blood Glucose	Evaluating change in fasting blood glucose	6 weeks
Secondary	HbA1c	Evaluating change in HbA1c	6 weeks