The effect of Glycomax 'Trademark' lactoferrin and bovine whey immunoglobulin-rich fraction on gene expression patterns in healthy adults: a double-blind placebo-controlled randomised clinical trial

In healthy adults do Glycomax 'Trademark' lactoferrin and bovine whey immunoglobulin-rich fraction supplements influence gene expression patterns?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000462684

Enrollment

124

Registered

2014-05-02

Start date

2014-07-07

Completion date

2015-04-28

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

Growing research into the effects of several whey-derived proteins (cow’s milk proteins) suggests that bovine lactoferrin and immunonglobulins may have a number of health benefits for consumers including improved metabolic and immune regulation. This study aims to examine any link between bovine lactoferrin and immunoglobulin consumption and gene expression patterns which may reveal which biological pathways are involved in driving responses to these supplements.

Interventions

Supplementation for 28 days with oral supplements once daily from one of six possible treatments Arm 1: Lactoferrin 200mg Arm 2: Whey Ig-rich Fraction 200mg Arm 3: Whey Ig-rich Fraction 800mg Arm 4: Lactoferrin 200mg + Whey Ig-rich fraction 200mg Arm 5: Lactoferrin 200mg + Whey Ig-rich faction 800mg Arm 6: Placebo Compliance will be encouraged with a daily checklist and monitored by supplement return at the end of the intervention period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

For inclusion into the study, participants are required to be: aged between 18-55 years; in current good health; have Body Mass Index (BMI) <30 kg/m2

Exclusion criteria

Participants will be excluded from participation if they: are lactose intolerant; consume of fish oil, probiotics, prebiotics, whey protein supplements during the trial period; require insulin use (for treatment of diabetes); have a history of liver, kidney or thyroid disease; use anti-inflammatory or immune-modulating medications; have heavy alcohol consumption (according to the CDC definitions); are pregnant or intending to become pregnant during the trial period; have had high level of radiation exposure over the preceding 12 months

Outcome results