The antioxidant and immunomodulatory effects of a Marinova seaweed extract on healthy individuals

Phase 1

• Conditions: Antioxidant and immune cell function; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12607000228482
• Lead Sponsor: Marinova Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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 supplementsIndividuals with poor venous accessIndividuals with auto-immune disordersIndividuals taking steroid medication or NSAID (non steroidal anti inflammatory drugs)treatmentsIndividuals with diabetesIndividuals taking anticoagulantsIndividuals taking immune suppressant drugsIndividuals taking cytokine or interferon therapyIndividuals taking Echinacea or other immune stimulating herbsIndividuals with clinically abnormal liver function tests at baselineIndividuals who develop a cold or other acute URTI (upper respiratory tract infection) or influenza during the course of the studyIndividuals unwilling to have blood taken 4 times during the studyIndividuals unwilling to comply with the study protocolsIndividuals with any other condition which in the opinion of the researchers could compromise the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In vivo changes in lymphocyte subsets and ex vivo changes in lymphocyte activation[Each outcome will be measured at: Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.];In vivo changes in lymphocyte subsets and ex vivo changes in phagocytosis of granulocytes and monocytes[Each outcome will be measured at: Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.];In vivo changes in lymphocyte subsets and ex vivo changes in T helper1/T helper 2 cytokines[Each outcome will be measured at: Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.]

Secondary Outcome Measures

Name	Time	Method
Ex vivo changes in serum oxygen radical absorbance capacity[Each outcome is measured at Week 0 - Screening, Week 1 (Day 1) - Baseline measurement 1, Week 1 (Day 3) - Measurement 2, Week 4 - Measurement 3.]