The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels

Summary

Glutathione is a powerful protective substance found within every cell in the body. It has been shown that glutathione levels go down as a person gets older, which makes a person more likely to get heart disease, high blood sugar problems and different kind of cancers. N-Acetyl Cysteine is used as a dietary supplement. It has been reported to increase glutathione levels in the body. The diet supplement called ProImmune is also changed by the body into glutathione. Therefore, the purpose of this study is to find out the effect of ProImmune in healthy people. This study will also help to prove whether or not the ProImmune is able to improve the blood levels of glutathione in healthy people.

Conditions

• Oxidative Stress

Interventions

DRUG

Placebo low dose

This is a prospective randomized controlled pilot study, which will include twenty-four (24) healthy individuals.The first 12 subjects (low dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.

DRUG

N Acetyl cysteine, 600mg (low dose)

The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC).

DRUG

Proimmune 200 (FT061452) 3000mg low dose

The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low dose'

DRUG

Placebo (high dose)

The second sub set of 12 subjects (high dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.

DRUG

N Acetyl cysteine, 1200mg (high dose)

N Acetyl cysteine (high dose) N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.

DRUG

FT061452, 6000mg high dose

Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science

  lead OTHER

Principal Investigators

• Naureen Tareen, MD · Charles Drew University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2011-06-30

Completion

2011-06-30

Countries

• United States

Study Locations