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Trial record 53 of 581 for:    reduced glutathione

Energetics and Function in Older Humans

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ClinicalTrials.gov Identifier: NCT02348762
Recruitment Status : Active, not recruiting
First Posted : January 28, 2015
Last Update Posted : February 27, 2019
Sponsor:
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)
Estimated Enrollment : 20 participants
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
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cysteine/glycine
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02348762


Locations
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United States, Texas
Baylor Metabolic Research Unit (MRU)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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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
ClinicalTrials.gov Identifier: NCT02348762     History of Changes
Other Study ID Numbers: H-34686 Glutathione and Aging
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Acetylcysteine
N-monoacetylcystine
Glycine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Glycine Agents
Neurotransmitter Agents