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Energetics and Function in Older Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02348762
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : February 11, 2022
Information provided by (Responsible Party):
Rajagopal V Sekhar, Baylor College of Medicine

Brief Summary:
The investigators have previously reported that older patients with HIV are deficient in glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and improves concentrations of red-cell GSH. The investigators also found that when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an increase in intracellular GSH concentrations. The current proposal will investigate if cysteine and glycine supplementation for a duration of 24 weeks will result in changes in : (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after completing supplementation, measurement of GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests will be done to determine the effects of washout.

Condition or disease Intervention/treatment Phase
Aging Erythrocyte Glutathione Deficiency Muscle Weakness Dietary Supplement: Cysteine (as n-acetylcysteine) and Glycine Phase 1

Detailed Description:
Data not available at present

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Energetics and Function in Older Humans
Study Start Date : November 2014
Actual Primary Completion Date : November 2018
Actual Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Glycine and N-acetylcysteine
Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months
Dietary Supplement: Cysteine (as n-acetylcysteine) and Glycine
Older subjects will be studied before and after receiving cysteine and glycine

Primary Outcome Measures :
  1. Red blood cell concentrations of Glutathione measured by HPLC [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Older subjects:

  • age 70-80 years;

Younger subjects:

  • age 21-30 years

Exclusion Criteria:

  1. No known diabetes, liver disease, kidney disease, coronary heart disease, stroke, or cancer;
  2. Any limitations in ability to walk;
  3. Triglyceride concentrations greater than 500 mg/dl (if lipid lowering medications are stopped);
  4. BMI less than 20.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02348762

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United States, Texas
Baylor Metabolic Research Unit (MRU)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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Principal Investigator: R V Sekhar, M.D. Baylor College of Medicine
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Responsible Party: Rajagopal V Sekhar, Principal Investigator, Baylor College of Medicine Identifier: NCT02348762    
Other Study ID Numbers: H-34686 Glutathione and Aging
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Glycine Agents
Neurotransmitter Agents