The antioxidant and immunomodulatory effects of Ambrotose AO in healthy smokers and non-smokers

Phase 3

Completed

• Conditions: Antioxidant activity and immune function; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12605000258651
• Lead Sponsor: Mannatech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Individuals willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.

Exclusion Criteria

1. Individuals taking antioxidant medications and/or supplements2. Individuals with poor venous access3. Individuals with auto-immune disorders4. Individuals with diabetes5. Individuals taking immune suppressant drugs6. Individuals taking cytokine or interferon therapy7. Individuals taking Echinacea or other immune stimulating herbs8. Individuals with clinically abnormal liver function tests at baseline9. Individuals unwilling to have blood taken 9 times during the study10. Individuals unwilling to comply with the study protocols11. Individuals with any other condition which in the opinion of the researchers could compromise the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ex vivo changes in serum oxygen radical capacity.[Measured week 3, week 4, week 5, week 6.]

Secondary Outcome Measures

Name	Time	Method
In vivo changes in lymphocyte subsets[Measured weekly];Urinary iPF2[Measured weekly];Phagocytosis of granulocytes and monocytes[Measured weekly];COX 2 activity[Measured weekly]