Effect of Dietary Amino Acid Profile on Lipoprotein Metabolism, Vascular Reactivity and Inflammatory Markers
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Purpose
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 | Intervention |
|---|---|
|
Hyperlipidemias Metabolic Syndrome X Cardiovascular Diseases |
Behavioral: Comparison of dietary protein amino acid profile |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Effect of Dietary Amino Acid Profile on Lipoprotein Metabolism, Vascular Reactivity and Inflammatory Markers |
- Serum lipid and lipoprotein concentrations, endothelial function, blood pressure, indicators of nitrous oxide end products, homocysteine, inflammation and oxidation markers. [ Time Frame: 5 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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Behavioral: Comparison of dietary protein amino acid profile
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.
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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 CVD
- 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
- 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| United States, Massachusetts | |
| Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Alice H Lichtenstein, D.Sc. | Tufts Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Tufts University |
| ClinicalTrials.gov Identifier: | NCT00175084 History of Changes |
| Other Study ID Numbers: | HL58008-1188 |
| Study First Received: | September 8, 2005 |
| Last Updated: | November 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hyperlipidemias Metabolic Syndrome X Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders |
ClinicalTrials.gov processed this record on May 23, 2013