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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000078358

Enrollment

Registered

2008-02-13

Start date

2006-07-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 Ambrotose Phyto Formula. The medication was taken for 5 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Outcome results