Hypertriglyceridemia Clinical Trial
Official title:
Effects of Amino Acids on Regional Lipid Metabolism
Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of death in America. The overall goal of this project is to test a novel treatment using nutrient (amino acid) supplementation against this condition in men and women, and to understand how this treatment works.
Coronary heart disease (CHD) remains the single largest killer of American men and women
(45). Hyper¬triglyceridemia (elevated triglyceride [TG] concentration in the blood) has been
shown to be a significant independent risk factor for CHD (7;8;25), accordingly, treatment
for hypertriglyceridemia has been included in the Adult Treatment Panel III (ATP III) of the
National Cholesterol Education Program (36). In a meta-analysis of 21 population-based
prospective studies including a total of 65,863 men and 11,089 women, each increase of 89
mg/dl (1 mmol/l) in TG concentration was associated with a 32% increase in CHD risk in men
and 76% increase in women (3). Thus, hypertriglyceridemia is an even stronger risk factor
for CHD in women than in men.
The prevalence of hypertriglyceridemia is high. It is a common finding with aging, and is
also associated with overweight, obesity, diabetes, and renal disease (39). With the aging
of the US population and ongoing epidemics of obesity and type 2-diabetes, the number of
individuals with conditions associated with elevated TG levels is likely to grow.
4.1.2 Effect of Amino Acids on Plasma Triglyceride Concentration In an effort to clarify the
potential independent effect of protein on plasma and tissue lipids, we supplemented a
normal weight-maintaining diet with a relatively small amount of amino acids (~90 kcal/day)
between meals. We measured tissue lipids in addition to plasma lipids since the increase in
insulin resistance with aging has been linked to increased fat accumulation in muscle and
liver tissue (20;63). Also, it has repeatedly been shown that amino acid intake stimulates
muscle protein synthesis and improves muscle protein net balance (86). Our hypothesis was
that supplementation of the normal diet with a mixture of amino acids will reduce
circulating and tissue TG concentrations and improve insulin sensitivity in elderly subjects
with impaired glucose tolerance. Twelve impaired glucose tolerant elderly ingested 11 g of
essential amino acids (EAA) + arginine twice a day for 16 weeks, after a 7 week control run
in. Diet and activity were not otherwise modified. We found individuals consuming the EAA
supplement had improved physical function. Further, these individuals had lower plasma and
liver TG concentrations than before supplementation, and total cholesterol and
VLDL-cholesterol concentrations were also lower after supplementations (12). In the present
study, we will investigate this by supplementing the diet of older subjects shown to have
hypertriglyceridemia.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| 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 |
NCT01455844 -
TRIal For Efficacy of Capre on hyperTriglyceridemiA
|
Phase 2 | |
| Completed |
NCT01437930 -
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
|
N/A | |
| Completed |
NCT00959842 -
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
|
Phase 1/Phase 2 | |
| Completed |
NCT01010399 -
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
|
Phase 4 | |
| 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 |
NCT04630366 -
A Phase 1, First Time in Humans Study of NST-1024
|
Phase 1 | |
| Completed |
NCT04650152 -
Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
|
||
| 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 |