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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
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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

First Posted
January 15, 2015
Last Updated
January 28, 2022
Sponsor
Baylor College of Medicine
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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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