Energetics and Function in Older Humans

Aging Clinical Trial

Official title:

Energetics and Function in Older Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348762
• Other study ID #: H-34686 Glutathione and Aging
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: March 2021

Study information

• Verified date: January 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Data not available at present

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2021
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Erythrocyte Glutathione Deficiency
• Muscle Weakness

Intervention

Dietary Supplement:
• Cysteine (as n-acetylcysteine) and Glycine
Older subjects will be studied before and after receiving cysteine and glycine

Locations

Country	Name	City	State
United States	Baylor Metabolic Research Unit (MRU)	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Red blood cell concentrations of Glutathione measured by HPLC		8 months