Efficacy of Selenium Enriched Milk Study 2007

A 112 day parallel study investigating the effects of selenium enriched milk on the incidence, duration and severity of upper respiratory tract infections in healthy volunteers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000251426

Acronym

Enrollment

150

Registered

2007-05-10

Start date

2007-04-10

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

Parallel study of 150 healthy participants (male and female) 65 years of age or more who pass the inclusion criteria will be randomly assigned to 2 interventions. • Approx. 75 people, to receive placebo (control) for a total of 112 days • Approx. 75 people, isonitrogenous and isocaloric Se-enriched powdered milk supplement approx 120-150 ug Se/ day for a total of 112 days. The non-vaccinated volunteers will be inoculated with influenza vaccine at a common time point between 28 and 42 days (4 and 6 weeks) after starting the supplement. Blood samples (20mL) will be collected during the experiment (days 0, one day between 28 and 42,112 and 150) to quantitate blood selenium, anti-oxidant status and immune function. Compliance and upper respiratory tract infection data will be collected by the volunteer for the duration of the study. This data will be retrieved from the volunteer at the conclusion of the study. From these measurements, it shall be determined whether increased immune function was achieved during nutritional supplementation with the Se-enriched milk supplement compared to control.

Interventions

112 day intervention of: selenium enriched milk protein in volunteers who have already had the influenza vaccine and in volunteers who will be given the influenza vaccine. Volunteers are required to consume 50gm of the randomly allocated milk protein once daily mixed with 200ml of tap water.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Agree to informed consent

Exclusion criteria

Does not agree with informed consent• Allergic/Intolerant to dairy products• Unable to receive influenza vaccine (for example, has an egg allergy)• Negative health event that occurs during the trial that makes it unreasonable for participants to continue (such as heart attack)• A bleeding disorder (such as Haemophilia), or taking medication (such as anti-coagulants) that may preclude venipuncture • Taking selenium supplements, or supplementing with vitamins/ anti-oxidants such as folate, vitamins B12, C and E at levels above RDI• Unable to comprehend/ comply with study protocol• Not available for all sampling phases of the experiment• Chronic degenerative diseases• Chronic colitis• Chronic airway disease• Diabetes• Cancer• Significant heart disease

Outcome results