Energetics and Function in Older Humans

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02348762

Enrollment

Registered

2015-01-28

Start date

2014-11-30

Completion date

2021-03-31

Last updated

2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness

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.

Detailed description

Data not available at present

Interventions

DIETARY_SUPPLEMENTCysteine (as n-acetylcysteine) and Glycine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Red blood cell concentrations of Glutathione measured by HPLC	8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026