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

NCT00175084 | Completed

• 1 other identifier: HL58008-1188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemias; Metabolic Syndrome X; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

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

  5 week

Interventions

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.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Links

• Click here for more information about this study:

MeSH Terms

Conditions

Hyperlipidemias; Metabolic Syndrome; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Alice H Lichtenstein, D.Sc.

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2012
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

US (1)