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

Participant: Healthy individuals Intervention: Seaweed extract Comparator: Dose comparison Outcome: In vivo changes in lymphocyte subsets and ex vivo changes in lymphocyte activation, phagocytosis of granulocytes and monocytes, and T helper1/T helper 2 cytokines.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000228482

Acronym

N/A

Enrollment

Registered

2007-05-01

Start date

2007-07-02

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 purpose of the study is to determine the effects of a natural medicine formulation on antioxidant and immune cell function. The study hypothesises that the oral administration of the study medication over 4 weeks will result in a statistically significant lowering of fasting laboratory values of immune cell function, compared with baseline levels.

Interventions

Seaweed extract taken from marine microalgae, Five of the participants will take two 500mg capsules of the study medication and five will take one 100mg capsule daily, with food. The study will continue for 28 days after the initial screening visit, measurement points will be at screening, day1, day 3 and week 4.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 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

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.

Outcome results