CompletedPhase 3ACTRN12608000078358

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

A randomised controlled study on Healthy Individuals to evaluate the efficacy of glyco-nutrient therapy compared to placebo on antioxidant and various immune cell functions with end of study outcomes.

Sponsor

Mannatech, Inc

Enrollment

60 participants

Start Date

Jul 4, 2006

Study Type

Interventional

Conditions

Immune system function in healthy individuals Antioxidant levels in healthy individuals

Summary

The study is a double blind, placebo controlled, randomised trial to be conducted over 6 weeks in parallel groups of otherwise healthy individuals. The study will compare baseline in vivo and ex vivo changes of antioxidant levels and various immune cell functions with end of study outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria1

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

Exclusion Criteria1

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.

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Interventions

Ambrotose AO Glyco-antioxidant Therapy. Two tablets were taken orally morning and night. The active medication contained 18 international units vitamin E, 113 mg Mannatech AO blend and 333mgs of Amb

Ambrotose AO Glyco-antioxidant Therapy. Two tablets were taken orally morning and night. The active medication contained 18 international units vitamin E, 113 mg Mannatech AO blend and 333mgs of Ambrotose Phyto Formula. The medication was taken for 5 weeks.

Locations(1)

Australia

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ACTRN12608000078358