Energetics and Function in Older Humans

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02348762
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 76
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Energetics and Function in Older Humans
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Red blood cell concentrations of Glutathione measured by HPLC [8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor Metabolic Research Unit (MRU)	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rajagopal V Sekhar, Principal Investigator, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02348762
• Other Study ID Numbers: H-34686 Glutathione and Aging
• First Posted: Jan 28, 2015
• Last Update Posted: Feb 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Muscle Weakness; Acetylcysteine; N-monoacetylcystine; Glycine

Study Results

No Results Posted as of Feb 11, 2022