Energetics and Function in Older Humans

NCT02348762 | Completed Phase 1

• 1 other identifier: H-34686 Glutathione and Aging
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Erythrocyte Glutathione Deficiency; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• Red blood cell concentrations of Glutathione measured by HPLC

  8 months

Study Arms (1)

Glycine and N-acetylcysteine

EXPERIMENTAL

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

Interventions

Cysteine (as n-acetylcysteine) and Glycine DIETARY_SUPPLEMENT

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

Glycine and N-acetylcysteine

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older subjects:
• age 70-80 years;
• Younger subjects:
• age 21-30 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor Metabolic Research Unit (MRU)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Cysteine; Glycine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Sulfhydryl Compounds; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• R V Sekhar, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 28, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: March 1, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)