Energetics and Function in Older Humans
Primary Purpose
Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cysteine (as n-acetylcysteine) and Glycine
Sponsored by
About this trial
This is an interventional basic science trial for Aging
Eligibility Criteria
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.
Sites / Locations
- Baylor Metabolic Research Unit (MRU)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glycine and N-acetylcysteine
Arm Description
Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months
Outcomes
Primary Outcome Measures
Red blood cell concentrations of Glutathione measured by HPLC
Secondary Outcome Measures
Full Information
NCT ID
NCT02348762
First Posted
January 15, 2015
Last Updated
January 28, 2022
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02348762
Brief Title
Energetics and Function in Older Humans
Official Title
Energetics and Function in Older Humans
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
Data not available at present
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Erythrocyte Glutathione Deficiency, Muscle Weakness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glycine and N-acetylcysteine
Arm Type
Experimental
Arm Description
Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Cysteine (as n-acetylcysteine) and Glycine
Intervention Description
Older subjects will be studied before and after receiving cysteine and glycine
Primary Outcome Measure Information:
Title
Red blood cell concentrations of Glutathione measured by HPLC
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R V Sekhar, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Metabolic Research Unit (MRU)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Energetics and Function in Older Humans
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