Trial of Oral Glutamine on Mitochondrial Function in CKD

Summary

The primary goal of proposed investigation is to study the impact of oral glutamine supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial energetics and vascular function using 31P magnetic resonance spectroscopy and optical spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as well as inflammatory and oxidative stress biomarkers among persons with chronic kidney disease.

Conditions

• Cardiovascular Disease
• Sarcopenia
• Endothelial Dysfunction
• Muscle Mitochondrial Function
• Kidney Disease

Interventions

DIETARY_SUPPLEMENT

First Intervention (14 days)

Oral Glutamine or Maltodextrin for 2 weeks

OTHER

Washout (3 weeks)

No study product is taken prior to beginning crossover

DIETARY_SUPPLEMENT

Second Intervention (14 days)

Oral Glutamine or Maltodextrin for 2 weeks

Sponsors & Collaborators

• New York Medical College

  collaborator OTHER

• Emory University

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Jonathan Himmelfarb, MD · Kidney Research Insitute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-25

Primary Completion

2017-10-01

Completion

2018-01-31

FDA Drug

Yes

Countries

• United States

Study Locations