At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PILOT: The Effects of Short Term Administration of a Novel Glutathione Precursor (FT061452), on Serum and Intracellular Glutathione Levels
In Brief
A Phase 1 clinical trial evaluating Placebo low dose, N Acetyl cysteine, 600mg (low dose), and 4 other interventions for Oxidative Stress. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC).
The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low 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.
N Acetyl cysteine (high dose) N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.
Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.