- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02611102
Effect of Butter & MCT Oil on Lipoproteins - A RCT
Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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:
- non-HDL-c
- LDL-c
- triglycerides
- BP
- waist circumference
- FBG
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thanh D Hoang, DO
- Phone Number: 301-295-6220
- Email: thanh.d.hoang.mil@mail.mil
Study Contact Backup
- Name: Iris E Robbins, BA
- Phone Number: 301-319-2869
- Email: iris.e.robbins1.civ@mail.mil
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- DoD healthcare beneficiaries
- willing to drink 2 to 4 cups of coffee daily
- between the ages of 18 to 45
- serum LDL-c < 160,
- non-HDL-c < 190
- apoB < 120
Exclusion Criteria:
- BMI > 30kg/m2 or < 20kg/m2 or waist circumference > 102cm (males) or 88cm (females)
- Triglycerides > 150
- Hypertension defined as SBP > 150, DBP > 90 or on treatment for high blood pressure
- Chronic liver disease defined by any clinical or a history of serum AST or ALT > 3 times ULN
- Kidney disease defined as a GFR <90 ml/min or history of nephritic syndrome
- Impaired glucose metabolism defined as HbA1c > 5.6, FBG > 99, or 2-hour OGTT > 139
- Any known malignancy
- Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
- Hypothyroidism per lab evaluation at baseline
- Pregnancy
- Polycystic Ovary Syndrome or irregular menstrual periods
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
- Cushing's syndrome per medical history or clinical suspicion
- HIV per medical history
- Chronic Inflammatory Disorders such as, but not limited to, SLE, RA, IBD per medical history
- History of tobacco use within the previous 12 months to include cigarettes, e-cigarettes, chewing tobacco, cigars, and pipes.
- History of marijuana use within the previous 12 months
- Active intentional weight loss of over 5% in the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MCT oil + Butter in Coffee
This group will be provided with MCT oil and butter to add to their daily coffee intake.
|
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.
|
Placebo Comparator: Low calorie coffee
This group will continue to drink their normal daily coffee with < 50kcal of creamer and/or sweetener.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in apolipoprotein B
Time Frame: Baseline and 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
non-HDL-c
Time Frame: 6 weeks
|
Evaluating change in non-HDL_c
|
6 weeks
|
LDL-c
Time Frame: 6 weeks
|
Evaluating change in LDL-c
|
6 weeks
|
triglycerides
Time Frame: 6 weeks
|
Evaluating change in triglycerides
|
6 weeks
|
Blood pressure
Time Frame: 6 weeks
|
Evaluating change in blood pressure
|
6 weeks
|
waist circumference
Time Frame: 6 weeks
|
Evaluating change in waist circumference
|
6 weeks
|
Fasting Blood Glucose
Time Frame: 6 weeks
|
Evaluating change in fasting blood glucose
|
6 weeks
|
HbA1c
Time Frame: 6 weeks
|
Evaluating change in HbA1c
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thanh D Hoang, DO, WRNMMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 404482-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hyperlipidemia
-
Drug Commission of the German Medical AssociationMadaus AGTerminatedHypercholesterolemia | Combined Hyperlipidemia
-
Misr University for Science and TechnologyActive, not recruiting
-
DongKoo Bio & PharmaUnknownHyperlipidemia, HypertriglyceridemiaKorea, Republic of
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHypercholesterolemia and HyperlipidemiaChina
-
Jeil Pharmaceutical Co., Ltd.CompletedHypertension With HyperlipidemiaKorea, Republic of
-
PfizerWithdrawnPrimary Hyperlipidemia or Mixed DyslipidemiaChina
-
ShionogiIntegriumCompletedCombined HyperlipidemiaUnited States
-
IlDong Pharmaceutical Co LtdCompletedHypertension With HyperlipidemiaKorea, Republic of
-
HK inno.N CorporationCompletedHypertension With Hyperlipidemia
-
LG Life SciencesCompletedHypertension, HyperlipidemiaKorea, Republic of
Clinical Trials on MCT oil + Butter in Coffee
-
Université de SherbrookeCompleted
-
Chiayi Christian HospitalCompletedGrowth | Preterm Infants | MCT Oil MassageTaiwan
-
Université de SherbrookeFondation VitaeCompletedAlzheimer's DiseaseCanada
-
Clinical Nutrition Research Centre, SingaporeCompletedDiabetes Mellitus, Type 2 | Cardiovascular Risk FactorSingapore
-
Joseph BlissTufts UniversityCompletedCandida Infection | Premature InfantUnited States
-
Université de SherbrookeCompleted
-
University of CopenhagenThe Danish Dairy Research Foundation, DenmarkCompleted
-
King's College LondonCompleted
-
National Institute of Neurological Disorders and...CompletedParkinson's DiseaseUnited States