Whole Foods versus Supplements to Reduce Oxidative Stress in the Airways

A placebo-controlled, cross-over, supplementation trial establishing the comparative efficacy of lycopene capsules and tomato juice on airway hyperresponsiveness in stable asthma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000125628

Enrollment

Registered

2005-08-11

Start date

2004-05-27

Completion date

2005-09-14

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

This study examines the ability of oral lycopene supplements (provided in the form of tomato extract capsules and tomato juice) to improve biochemical and clinical markers in stable asthma

Interventions

Subjects receive three treatments in random order, each for 7 days. The treatments are tomato juice (840mL/day), lycomato extract (3 capsules /day) and placebo (3 capsules /day). The tomato juice and lycomato provide a lycopene dose of 45mg /day. Before and between each treatment subjects undergo a 10 day washout period on a low antioxidant diet.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Current asthmatics.

Exclusion criteria

1.) Current smokers2.) Other respiratory diseases3.) Unable to produce sputum sample4.) Currently using vitamin or herbal supplement.

Outcome results