An exploration of the antioxidant, immunomodulatory, and anti-inflammatory activities of Ambrotose in healthy individuals.

Phase 3

Completed

• Conditions: Immune system function in healthy individuals; Antioxidant levels in healthy individuals; Inflammatory and Immune System - Normal development and function of the immune system; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12608000078358
• Lead Sponsor: Mannatech, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Individuals taking antioxidant medications and/or supplements. Individuals with poor venous access. Individuals with auto-immune disorders or an immune disease. Individuals taking steroid medication or non steroidal anti-inflammatory drugs (NSAID) treatments. Individuals with diabetes. Individuals taking anticoagulants. Individuals taking immune suppressant drugs. Individuals taking cytokine or interferon therapy. Individuals taking Echinacea or other immune stimulating herbs. Individuals with clinically abnormal liver function tests at baseline. Individuals who develop a cold or other acute upper respiratory tract infection (URTI) or influenza during the course of the study. Individuals unwilling to have blood taken 6 times during the study. Individuals unwilling to comply with the study protocols. 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 absorbance capacity.[Measured over an 8 week period at baseline (week -2) week 0, week 1, week 3 and week 5.]

Secondary Outcome Measures

Name	Time	Method
In vivo changes in lymphocyte subsets, lymphocyte activation, Phagocytosis of Granulocytes and Monocytes, and Cyclo oxygenase (COX 2) (anti inflammatory) activity. Participants had blood samples taken at weeks -2, 0, 1, 3 and 5 to measure these outcomes.[This was measured over an 8 week period at baseline (week -2) week 0, week 1, week 3 and week 5.]