Effects of Amino Acids on Regional Lipid Metabolism (NH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Arkansas
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01150188
First received: June 22, 2010
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

Elevated fat level in blood is a risk factor for coronary heart disease, a major cause of death in America. The overall goal of this project is to test a novel treatment using nutrient (amino acid) supplementation against this condition in men and women, and to understand how this treatment works.


Condition Intervention
Hypertriglyceridemia
Dietary Supplement: Amino acids
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Amino Acids on Regional Lipid Metabolism

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Very low density lipoprotein (VLDL) turnover [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Turnover rates of VLDL-triglycerides and VLDL-ApoB-100, including synthesis and breakdown rates, measured before and after eight weeks of amino acid supplementation


Secondary Outcome Measures:
  • Fat oxidation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Fat oxidation measured before and after eight weeks of amino acid supplementation

  • Lipolysis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Lipolysis measured before and after eight weeks of amino acid supplementation

  • Triglyceride uptake in muscle and adipose tissue [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    Triglyceride uptake in muscle and adipose tissue measured before and after eight weeks of amino acid supplementation


Estimated Enrollment: 125
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amino acids
Amino acid supplementation between meals for eight weeks
Dietary Supplement: Amino acids
11 g amino acids two times per day for eight weeks
Placebo Comparator: Placebo
Supplementation of placebo (inert components) between meals for eight weeks
Dietary Supplement: Placebo
Placebo of inert compounds, 11 g two times per day for eight weeks

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 50-75 years.
  • Men and Women (Women postmenopausal).
  • Ability to sign informed consent, including ≥26 Mini-Mental State Exam.
  • Plasma triglyceride concentration between 130-500 mg/dl.

Exclusion Criteria:

  • Diabetes (plasma glucose: fasting ≥126 mg/dl or ≥200 mg/dl at 2 hr after 75 g glucose load).
  • On diabetes medication or lipid altering agents, including over the counter fish oil/omega 3 fatty acids.
  • Kidney/renal or liver disease.
  • Bleeding disorders or anemia.
  • Endocrine disease.
  • Positive hepatitis or HIV screens.
  • Alcohol abuse or drug abuse
  • Score of <26 on the Mini-Mental State Exam.
  • Allergy to iodine or fish products.
  • Subjects with cerebral aneurysm clips, internal transistorized devices (e.g., neural stimulators), or cardiac pacemakers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150188

Contacts
Contact: Leybi L Ramirez, MD.MPH 501)-364-3055 llramirez@uams.edu
Contact: Nick Hurren, PhD (501) 364-3054 Nmhurren@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Science, Reynolds Aging Institute Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Elisabet Borsheim, PhD    501-364-3053    EBorsheim@uams.edu   
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Elisabet Borsheim, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01150188     History of Changes
Other Study ID Numbers: 139210, 1R01AG033761-01A1
Study First Received: June 22, 2010
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
aging
lipid metabolism
very low density lipoproteins
amino acids
dietary supplements

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014