Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
MCT oil + Butter in Coffee
Enfermedades Cardiovasculares+1
+ Hiperlipidemias
+ Enfermedades metabólicas
Estudio de Prevención
Resumen
Fecha de inicio: 8 de marzo de 2016
Fecha en la que se inscribió al primer participante.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).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 80 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 45 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
50% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
PlaceboGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Walter Reed National Military Medical Center
Bethesda, United StatesAbrir Walter Reed National Military Medical Center en Google Maps