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

June 22, 2010
November 4, 2013
June 2010
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01150188 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Amino Acids on Regional Lipid Metabolism
Effects of Amino Acids on Regional Lipid Metabolism

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Hypertriglyceridemia
  • Dietary Supplement: Amino acids
    11 g amino acids two times per day for eight weeks
  • Dietary Supplement: Placebo
    Placebo of inert compounds, 11 g two times per day for eight weeks
  • Active Comparator: Amino acids
    Amino acid supplementation between meals for eight weeks
    Intervention: Dietary Supplement: Amino acids
  • Placebo Comparator: Placebo
    Supplementation of placebo (inert components) between meals for eight weeks
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
May 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
50 Years to 75 Years
Yes
Contact: Leybi L Ramirez, MD.MPH 501)-364-3055 llramirez@uams.edu
Contact: Nick Hurren, PhD (501) 364-3054 Nmhurren@uams.edu
United States
 
NCT01150188
139210, 1R01AG033761-01A1
No
University of Arkansas
University of Arkansas
National Institute on Aging (NIA)
Principal Investigator: Elisabet Borsheim, PhD University of Arkansas
University of Arkansas
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP