NCT02838979

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

July 8, 2016

Results QC Date

December 3, 2021

Last Update Submit

June 21, 2022

Conditions

Cardiovascular DiseaseSarcopeniaEndothelial DysfunctionMuscle Mitochondrial FunctionKidney Disease

Keywords

GlutamineChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Muscle Mitochondrial Function

    31P MRS/OS was used to measure mitochondrial phosphorylation capacity (ATPmax).

    2 weeks

Secondary Outcomes (2)

  • Change in Force-time Integral Area Under the Curve in Active Agent vs. Placebo

    2 weeks

  • Muscle Fatigue

    2 weeks

Other Outcomes (1)

  • Plasma NAD+ Levels

    2 weeks

Study Arms (2)

Oral L-Glutamine first, then Maltodextrin

EXPERIMENTAL

Subjects will receive 0.4 g/kg/day of L-glutamine (Nutrestore, EMMAUS Life Sciences, Inc Torrance, CA) in three divided daily doses OR identical appearing maltodextrin powder. Duration 2 weeks

Dietary Supplement: First Intervention (14 days)Other: Washout (3 weeks)Dietary Supplement: Second Intervention (14 days)

Maltodextrin first, then L-glutamine

EXPERIMENTAL

Subjects will crossover to receiving the study product which they did not receive in the first period. Either 0.4 g/kg/day of L-glutamine in three divided daily doses OR identical appearing maltodextrin powder. Duration 2 weeks

Dietary Supplement: First Intervention (14 days)Other: Washout (3 weeks)Dietary Supplement: Second Intervention (14 days)

Interventions

First Intervention (14 days)DIETARY_SUPPLEMENT

Oral Glutamine or Maltodextrin for 2 weeks

Maltodextrin first, then L-glutamineOral L-Glutamine first, then Maltodextrin
Washout (3 weeks)OTHER

No study product is taken prior to beginning crossover

Maltodextrin first, then L-glutamineOral L-Glutamine first, then Maltodextrin
Second Intervention (14 days)DIETARY_SUPPLEMENT

Oral Glutamine or Maltodextrin for 2 weeks

Maltodextrin first, then L-glutamineOral L-Glutamine first, then Maltodextrin

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between 20 and 69 years of age
  • Diagnosis of moderate-severe CKD, defined in this study as an estimated glomerular filtration rate (eGFR) of ≤60ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation
  • Ability to understand and provide informed consent to participate in the study

You may not qualify if:

  • On chronic dialysis
  • Expectation to start dialysis within 6 months or dialysis access in place.
  • Pregnant
  • Have physical immobility (defined by wheelchair use)
  • Insulin dependent diabetes
  • Have implants incompatible with MRI
  • Exercise limiting cardiopulmonary disease (e.g. angina, severe heart valve disease, severe COPD, coronary ischemia)
  • Use of anticoagulation (i.e. warfarin)
  • Baseline systolic blood pressure \>160 or diastolic blood pressure \>100
  • Inflammatory conditions (e.g. autoimmune disease, HIV)
  • Thyroid disease
  • Dementia or inability to consent
  • Cirrhosis, active/chronic hepatitis
  • Use medications interfering with muscle or mitochondrial function, including steroids, anti-psychotic, Coenzyme Q-10, immunosuppresssives, antivirals, and muscle relaxants
  • Weight \>300 lbs
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kidney Research Institute, University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (3)

  • Ziegler TR, Benfell K, Smith RJ, Young LS, Brown E, Ferrari-Baliviera E, Lowe DK, Wilmore DW. Safety and metabolic effects of L-glutamine administration in humans. JPEN J Parenter Enteral Nutr. 1990 Jul-Aug;14(4 Suppl):137S-146S. doi: 10.1177/0148607190014004201.

    PMID: 2119459BACKGROUND

  • Amara CE, Marcinek DJ, Shankland EG, Schenkman KA, Arakaki LS, Conley KE. Mitochondrial function in vivo: spectroscopy provides window on cellular energetics. Methods. 2008 Dec;46(4):312-8. doi: 10.1016/j.ymeth.2008.10.001. Epub 2008 Oct 16.

    PMID: 18930151BACKGROUND

  • Jones DP, Liang Y. Measuring the poise of thiol/disulfide couples in vivo. Free Radic Biol Med. 2009 Nov 15;47(10):1329-38. doi: 10.1016/j.freeradbiomed.2009.08.021. Epub 2009 Aug 26.

    PMID: 19715755BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesSarcopeniaKidney DiseasesRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic Processes

Results Point of Contact

Title
Ernest Ayers
Organization
University of Washington
ayerse@uw.edu
206-685-1423

Study Officials

  • Jonathan Himmelfarb, MD

    Kidney Research Insitute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 20, 2016

Study Start

February 25, 2016

Primary Completion

October 1, 2017

Study Completion

January 31, 2018

Last Updated

July 14, 2022

Results First Posted

July 14, 2022

Record last verified: 2022-03

Locations

US(1)