Effects of Amino Acids on Regional Lipid Metabolism

NCT01150188 | Completed

• 2 other identifiers: 1392101R01AG033761-01A1
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertriglyceridemia

Keywords

aging; lipid metabolism; very low density lipoproteins; amino acids; dietary supplements

Outcome Measures

Primary Outcomes (1)

• Very low density lipoprotein (VLDL) turnover

  Turnover rates of VLDL-triglycerides and VLDL-ApoB-100, including synthesis and breakdown rates, measured before and after eight weeks of amino acid supplementation

  Eight weeks

Secondary Outcomes (3)

• Fat oxidation

  8 weeks

• Lipolysis

  8 weeks

• Triglyceride uptake in muscle and adipose tissue

  Eight weeks

Study Arms (2)

Amino acids

ACTIVE COMPARATOR

Amino acid supplementation between meals for eight weeks

Dietary Supplement: Amino acids

Placebo

PLACEBO COMPARATOR

Supplementation of placebo (inert components) between meals for eight weeks

Dietary Supplement: Placebo

Interventions

Amino acids DIETARY_SUPPLEMENT

11 g amino acids two times per day for eight weeks

Amino acids

Placebo DIETARY_SUPPLEMENT

Placebo of inert compounds, 11 g two times per day for eight weeks

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Arkansas for Medical Science, Reynolds Aging Institute

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Elisabet Borsheim, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 24, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)