NCT02611102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 8, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

June 10, 2015

Last Update Submit

April 26, 2023

Conditions

Hyperlipidemia

Keywords

cardiovascular disease/medium-chain-triglycerides/cholesterol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • non-HDL-c

    6 weeks

  • LDL-c

    6 weeks

  • triglycerides

    6 weeks

  • Blood pressure

    6 weeks

  • waist circumference

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

MCT oil + Butter in Coffee

EXPERIMENTAL

This group will be provided with MCT oil and butter to add to their daily coffee intake.

Dietary Supplement: MCT oil + Butter in Coffee

Low calorie coffee

PLACEBO COMPARATOR

This group will continue to drink their normal daily coffee with \< 50kcal of creamer and/or sweetener.

Dietary Supplement: MCT oil + Butter in Coffee

Interventions

MCT oil + Butter in CoffeeDIETARY_SUPPLEMENT

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.

Low calorie coffeeMCT oil + Butter in Coffee

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

MeSH Terms

Conditions

HyperlipidemiasCardiovascular Diseases

Interventions

ButterCoffee

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant PreparationsBiological ProductsComplex MixturesBeverages

Study Officials

  • Thanh D Hoang, DO

    WRNMMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

November 20, 2015

Study Start

March 8, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

US(1)