Energetics and Function in Older Humans

Phase 1

Completed

• Conditions: Aging; Erythrocyte Glutathione Deficiency; Muscle Weakness
• Interventions: Dietary Supplement: Cysteine (as n-acetylcysteine) and Glycine

• Registration Number: NCT02348762
• Lead Sponsor: 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.

Detailed Description

Data not available at present

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-28
• Primary Completion: 2018-11
• Study Completion: 2021-03
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Older subjects:

• age 70-80 years;

Younger subjects:

• age 21-30 years

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycine and N-acetylcysteine	Cysteine (as n-acetylcysteine) and Glycine	Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months

Primary Outcome Measures

Name	Time	Method
Red blood cell concentrations of Glutathione measured by HPLC	8 months

Trial Locations

Locations (1)

Baylor Metabolic Research Unit (MRU); 🇺🇸 Houston, Texas, United States