Energetics and Function in Older Humans

NCT ID: NCT02348762

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-03-31

Brief Summary

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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

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Data not available at present

Conditions

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Aging Erythrocyte Glutathione Deficiency Muscle Weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Glycine and N-acetylcysteine

Older subjects will be studied before and after taking oral cysteine (as n-acetylcysteine) and glycine for 6 months

Group Type EXPERIMENTAL

Cysteine (as n-acetylcysteine) and Glycine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Cysteine (as n-acetylcysteine) and Glycine

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Rajagopal V Sekhar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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R V Sekhar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Baylor Metabolic Research Unit (MRU)

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-34686 Glutathione and Aging

Identifier Type: -

Identifier Source: org_study_id

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