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

• Sponsor: Tufts University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00175084
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 98
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias; Metabolic Syndrome X; Cardiovascular Diseases	Behavioral: Comparison of dietary protein amino acid profile	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Effect of Dietary Amino Acid Profile on Lipoprotein Metabolism, Vascular Reactivity and Inflammatory Markers
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

1. Serum lipid and lipoprotein concentrations, endothelial function, blood pressure, indicators of nitrous oxide end products, homocysteine, inflammation and oxidation markers. [5 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts University

Investigators

• Principal Investigator: Alice H Lichtenstein, D.Sc., Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for more information about this study:

Publications

None provided.

• Responsible Party: Tufts University
• ClinicalTrials.gov Identifier: NCT00175084
• Other Study ID Numbers: HL58008-1188
• First Posted: Sep 15, 2005
• Last Update Posted: May 23, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Hyperlipidemias

Study Results

No Results Posted as of May 23, 2014