Skip to main content
OpenTrials
Completed

NCT Number: NCT00175084

Effect of Dietary Amino Acid Profile on Lipoprotein Metabolism, Vascular Reactivity and Inflammatory Markers

The aim of this study is to explore the significance of the Lys:Arg ratio on responses of lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

About this study

Findings from early studies in a variety of experimental models of atherosclerosis on the effect of dietary protein suggested that proteins from vegetable sources are less cholesterolemic and atherogenic than proteins from animal sources. Throughout the later part of the 20th century there has been sporadic interest in the effect of protein type and amino acid profiles on blood lipid concentrations and atherosclerosis. A major focus for this evaluation has been to compare proteins based on their amino acid profile, often expressed as lysine (Lys) to arginine (Arg) ratio (Lys:Arg). While animal studies have provided important information regarding the significance of the Lys:Arg in determining the cholesterolemic response to a dietary protein, interpretation of these data must be done with caution since most of the studies have been conducted in animal models that have a different lipoprotein distribution and metabolism than humans. Moreover, the mechanistic insights of this response are yet to be determined. While the favorable effects of Arg on endothelial function appear to be consistent when Arg is administered using a supplement, the effects of dietary Arg naturally present in protein rich foods has yet to be determined. The aim of this proposal is to explore the significance of the Lys:Arg ratio on responses of lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 50-85 years
  • LDL-C concentrations >120 mg/dL

Exclusion criteria

  • Use of medications known to affect lipid metabolism
  • Established cardiovascular disease
  • Renal disease
  • Liver disease
  • Thyroid disease unless controlled with medication for at least 6 months
  • Type I and II diabetes
  • Irritable bowel syndrome
  • Chronic use of prescription anti-inflammatory medications
  • Smoking
  • Alcohol intake >7 alcoholic drinks per week
  • Unwillingness to maintain body weight during participation in the study
  • triglyceride (TG) > 400 mg/dL
  • Unwillingness to adhere to diet and study protocol
  • Weight gain or loss of more than 15 lb within 6 months prior to enrollment

Treatment and study plan

Comparison of dietary protein amino acid profile

Behavioral

Healthy adults over 50 years of age (men and postmenopausal women) will be assigned to one of two diets differing in lysine to arginine ration (0.7 vs. 1.4) for a 5 week period and then switched to the alternate diet, with a 2 to 4-week washout period, in a randomized crossover design. Blood samples will be collected three times in the fasted state and once 4-hours after the evening meal during the last week of each dietary period of measurement of concentration of plasma lipids, lipoproteins, apolipoproteins, arginine, C-reactive protein, nitrites/nitrates, homocysteine, lecithin-cholesterol acetyltransferase (LCAT), cholesteryl ester transfer protein (CETP), and LDL-receptor messenger ribonucleic acid (mRNA) expression.A 24-hour urine sample will be collected at the end of each phase to measure F2-isoprostanes as an indicator of whole body oxidation.

Primary outcomes

  1. Serum lipid and lipoprotein concentrations, endothelial function, blood pressure, indicators of nitrous oxide end products, homocysteine, inflammation and oxidation markers.

    Time frame: 5 week

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2012
First posted
Sep 15, 2005
Registry last updated
May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.