Energetics and Function in Older Humans

January 28, 2022 updated by: Rajagopal V Sekhar, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data not available at present

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor Metabolic Research Unit (MRU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Red blood cell concentrations of Glutathione measured by HPLC
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: R V Sekhar, M.D., Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-34686 Glutathione and Aging

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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