An exploration of the immunomodulatory, anti-inflammatory and antioxidant activities of bovine lactoferrin in healthy males (a pilot study)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000289617

Enrollment

Registered

2005-09-05

Start date

2005-05-10

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 explored the degree of safety and efficacy of a bovine lactoferrin supplement on healthy males by evaluating the in vivo and ex vivo changes of antioxidant and various immune cell functions.

Interventions

Day 8-14 100mg bovine lactoferrin 100mg calcium phosphate with excipient magnesium stearate Day 15-21 200mg bovine lactoferrin with excipient magnesium stearate.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

30 Years to 55 Years

Healthy volunteers

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

Individual taking antioxidant medications and /or supplements. Individuals with poor venous access. Individuals with auto-immune disorders. Individuals with diabetes. Individuals taking immune suppressant drugsÃ. Individuals taking cytokine or interferon therapy. Individuals taking Echinacea or other immune stimulating herbs. Individuals who smoke cigarettes or any other drug. Individuals with clinically abnormal liver function tests at baseline. Individuals unwilling to have blood taken 7 times during the study. Individuals unwilling to comply with the study protocols. Individuals with any other condition that in the opinion of the researchers could compromise the study.

Outcome results