Effects of Daily Butter & Medium-Chain Triglyceride Oil on Lipoproteins When Added to Baseline Diet a Randomized Controlled Trial
MCT oil + Butter in Coffee
Maladies Cardiovasculaires+3
+ Hyperlipidémies
+ Maladies métaboliques
Étude de prévention
Résumé
Date de début de l'étude : 8 mars 2016
Date à laquelle le premier participant a commencé l'étude.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).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.80 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 45 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
50% de chances d'être dans le groupe placebo en aveugle
Groupes de traitement
Groupe I
PlaceboGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Walter Reed National Military Medical Center
Bethesda, United StatesOuvrir Walter Reed National Military Medical Center dans Google Maps