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OpenTrials
Completed

NCT Number: NCT02348762

Energetics and Function in Older Humans

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baylor Metabolic Research Unit (MRU)

Houston, Texas, 77030, United States

About this study

Data not available at present

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Older subjects:

  • age 70-80 years;

Younger subjects:

  • age 21-30 years

Exclusion criteria

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

Treatment and study plan

Cysteine (as n-acetylcysteine) and glycine

Dietary Supplement

Older subjects will be studied before and after receiving cysteine and glycine

Primary outcomes

  1. Red blood cell concentrations of Glutathione measured by HPLC

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Jan 28, 2015
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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