NCT01870193

Brief Summary

Glutathione is an important antioxidant protein which protects cells from harmful oxidative stress. Elderly humans are known to have elevated oxidative stress and deficiency of glutathione, but it is not known whether there is deficient synthesis of glutathione in muscle tissue of elderly humans. Mitochondria are engines of cells where food consumed is burned to make energy. Under normal conditions the fuel of choice in the fasted state is fat, but fasted elderly humans are not able to oxidize fat as well as healthy young humans. Elderly humans also have the highest incidence and prevalence of being overweight and obese, and have increased storage of fat in liver and muscle. This study will help determine whether

  1. 1.elderly humans have diminished synthesis of glutathione in the skeletal muscle, and whether this can be improved by supplementing cysteine and glycine (and not an isonitrogenous placebo) in the diet;
  2. 2.improving muscle glutathione concentrations can also improve fuel oxidation in aging;
  3. 3.improvement of intracellular glutathione concentrations will be associated with a change in total body fat content

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2013

Longer than P75 for early_phase_1

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

April 23, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5.9 years

First QC Date

May 30, 2013

Last Update Submit

February 13, 2023

Conditions

Aging

Keywords

Glutathione deficiency in agingImpaired mitochondrial fatty-acid oxidation in aging

Outcome Measures

Primary Outcomes (1)

  • Muscle glutathione concentration

    Each subject will be studied over 4 months

Study Arms (3)

Young controls

ACTIVE COMPARATOR

Young controls will be studied before and after receiving cysteine and glycine for 2 weeks

Dietary Supplement: Glycine, cysteine (as n-acetylcysteine), alanine

Elderly active

ACTIVE COMPARATOR

Elderly subjects in the active group will receive glycine plus cysteine (as n-acetylcysteine) for 4 months, and be studied at baseline, 2 weeks and 4 months

Dietary Supplement: Glycine, cysteine (as n-acetylcysteine), alanine

Elderly placebo

PLACEBO COMPARATOR

Elderly subjects in the placebo group will receive alanine for 4 months, and be studied at baseline, 2 weeks and 4 months

Dietary Supplement: Glycine, cysteine (as n-acetylcysteine), alanine

Interventions

Glycine, cysteine (as n-acetylcysteine), alanineDIETARY_SUPPLEMENT

Young controls will receive cysteine plus glycine for 2 weeks The elderly subjects will be randomized in a double-blinded design to receive either cysteine plus glycine OR alanine for a period of 4 months

Elderly activeElderly placeboYoung controls

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly subjects: age range 61-80y.
  • Young healthy subjects: age range 21-40y

You may not qualify if:

  • Renal impairment (serum creatinine \>1.5 mg/dL)
  • Liver impairment (liver transaminases \>2x upper limit of normal)
  • Untreated/uncontrolled hyperthyroidism or hypothyroidism
  • Known hypercortisolemia
  • Known diabetes mellitus
  • Hospitalization in the past 3 months
  • BMI \<27 (elderly group)
  • Elderly women on estrogen replacement
  • Known pre-existing coronary artery disease
  • Fasted plasma triglyceride \>300 mg/dl (on lipid lowering medications)
  • Fasted plasma triglyceride \>500 mg/dl (off lipid lowering medications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Kumar P, Liu C, Suliburk J, Hsu JW, Muthupillai R, Jahoor F, Minard CG, Taffet GE, Sekhar RV. Supplementing Glycine and N-Acetylcysteine (GlyNAC) in Older Adults Improves Glutathione Deficiency, Oxidative Stress, Mitochondrial Dysfunction, Inflammation, Physical Function, and Aging Hallmarks: A Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2023 Jan 26;78(1):75-89. doi: 10.1093/gerona/glac135.

    PMID: 35975308DERIVED

MeSH Terms

Interventions

GlycineCysteineAlanine

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsSulfhydryl CompoundsAmino Acids, Neutral

Study Officials

  • R V Sekhar, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 5, 2013

Study Start

April 23, 2013

Primary Completion

March 1, 2019

Study Completion

August 22, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)