Hypertriglyceridemia Clinical Trial
Official title:
Metabolic Effects of Replacing Dietary Refined Carbohydrate With a Combination of Egg Protein and Unsaturated Fats in Men and Women With Elevated Triglycerides
The goal of this study is to evaluate the effects of replacing some refined starches and added sugars with a combination of egg protein and unsaturated fatty acids on markers of cardiometabolic health in men and women with hypertriglyceridemia.
The objective of this study is to evaluate the effects of a combination of egg protein and unsaturated fatty acids acting as substitutes for ~16% of energy from refined carbohydrate on the metabolic profile of men and women with elevated triglycerides. This is a randomized, controlled feeding, crossover trial that includes two screening/baseline visits, two 3-week treatment conditions, and a 2-week washout phase. Subjects consume a standardized background diet (7-day rotating menu) that incorporates at least 3 servings/day of study test foods, providing 40-60% of subjects' daily energy needs. Study test foods consist of yogurt, muffins, waffles, and cookies. The test foods account for 8% higher protein energy (from egg protein) and 8% higher fat energy (from unsaturated fatty acids) in the Active Condition compared to the Control Condition. In the Control Condition, the study foods account for 16% higher carbohydrate energy. The overall macronutrient composition of each condition is as follows: Active Condition, approximately 42/23/35% kcal from carbohydrate/protein/fat, respectively, and Control Condition, approximately 58/15/27% kcal from carbohydrate/protein/fat, respectively. Blood samples will be collected at baseline and end of treatment for measurement of metabolic parameters, and a liquid meal tolerance test (LMTT) will be conducted at baseline and the end of each treatment period. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Completed |
NCT02250105 -
Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT02859129 -
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
|
Phase 1 | |
Completed |
NCT01437930 -
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
|
N/A | |
Completed |
NCT01455844 -
TRIal For Efficacy of Capre on hyperTriglyceridemiA
|
Phase 2 | |
Completed |
NCT01010399 -
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
|
Phase 4 | |
Completed |
NCT00959842 -
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
|
Phase 1/Phase 2 | |
Completed |
NCT00519714 -
A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)
|
Phase 2/Phase 3 | |
Recruiting |
NCT00186537 -
Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.
|
N/A | |
Completed |
NCT00246402 -
Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV
|
N/A | |
Completed |
NCT06020950 -
Chia Seeds Consumption in Hypertriglyceridemia
|
N/A | |
Completed |
NCT02354976 -
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
|
Phase 2 | |
Completed |
NCT04966494 -
Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women
|
N/A | |
Completed |
NCT04650152 -
Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
|
||
Completed |
NCT04630366 -
A Phase 1, First Time in Humans Study of NST-1024
|
Phase 1 | |
Completed |
NCT03693131 -
Efficacy of MND-2119 in Participants With Hypertriglyceridemia
|
Phase 3 | |
Completed |
NCT02868177 -
Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
|
Phase 2/Phase 3 | |
Completed |
NCT04756180 -
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
|
Phase 3 | |
Completed |
NCT01968720 -
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT01462877 -
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
|
Phase 4 |