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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175084
• Other study ID #: HL58008-1188
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: May 21, 2014
• Start date: October 2004
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemias
• Metabolic Syndrome X

Intervention

Behavioral:
• Comparison of dietary protein amino acid profile
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.

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipid and lipoprotein concentrations, endothelial function, blood pressure, indicators of nitrous oxide end products, homocysteine, inflammation and oxidation markers.		5 week	No

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