Effects of Amino Acids on Regional Lipid Metabolism (NH)

This study is currently recruiting participants.
Verified November 2013 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: November 4, 2013
Last verified: November 2013
  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 2014
Estimated Primary Completion Date: March 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
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: November 4, 2013
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 April 17, 2014