A Clinical Trial to test the effectiveness of Lactoferrin (a protein found naturally in milk) in reducing the incidence and/or duration of the common cold.

A prospective phase IIa randomised placebo controlled study to evaluate the safety and efficacy of a Lactoferrin/Immunoglobulin preparation to prevent the onset of a cold or reduce the time of symptoms in pateints with a cold.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000201976

Enrollment

250

Registered

2011-02-21

Start date

2008-04-28

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

Whey proteins are normally found in milk. Supplementation appears to strengthen the immune system by promoting anti-bacterial activity. Lactoferrin is a protein isolated from whey proteins in milk with documented anti-bacterial, anti-fungal, anti-viral, and immune function strengthening effects. Studies have shown lactoferrin is an iron-binding protein that is present in body secretions such as tears, nasal exudates, saliva, and bronchial mucus. A high concentration is also found in breast milk to help the infant fight infection. Lactoferrin is also a major component of circulating white blood cells known as neutrophils and is released by these cells in infected areas. Further, lactoferrin has also been shown in laboratory experiments to bind to viral receptor sites and inhibit the growth of several viruses that include HIV, Herpes simplex 1 and 2, hepatitis C, and human cytomegalovirus. To date, there are no clinical trials that have specifically investigated the effect of lactoferrin to prevent or treat the common cold. However, because of its scientifically demonstrated antiviral, antibacterial, and anti-inflammatory properties, lactoferrin may be of benefit in alleviating the symptoms or complications of these viral infections and a clinical trial could introduce significant merit to clinical claims.

Interventions

Each gelatin capsules contains: Milled Glycomax Lactoferrin 220mg Glycomax Immunoglobulin 104mg Magnesium stearate 5.4mg Dosage: Oral ingestion of 2 capsules per day taken simulataneously in the morning for a total of 90 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Self report of 1-2 colds per month. Participants are classified as experiencing cold events frequently, self-limiting, non-chronic events but who are otherwise healthy, i.e. do not suffer from any serious health conditions such as cardiovascular disease, diabetes etc.

Exclusion criteria

The use of vitamin/mineral supplements, probiotics, herbs and fish oils for the duration of the trial. Femeals who are lactating, pregnant or planning to become pregnant. History of alcohol or substance abuse. History of serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, neurologic or neuropsychiatric disorders.

Outcome results