None listed
Conditions
Brief summary
The project was an open label, forced titration dose response study conducted over 5 weeks in 10 healthy smokers and 10 healthy non-smokers. Twenty-two subjects were enrolled in the study and were similarly treated with the study medication. Data was collected at baseline and then each week for a further 5 weeks.
Interventions
Ambrotose AO
Week 1 - Baseline 1;
Week 2 - Baseline 2;
Week 3 - 2 capsules daily;
Week 4 - 4 capsules daily
Week 5 - 8 capsules daily
Sponsors
Mannatech
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Individuals willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Exclusion criteria
1. Individuals taking antioxidant medications and/or supplements2. Individuals with poor venous access3. Individuals with auto-immune disorders4. Individuals with diabetes5. Individuals taking immune suppressant drugs6. Individuals taking cytokine or interferon therapy7. Individuals taking Echinacea or other immune stimulating herbs8. Individuals with clinically abnormal liver function tests at baseline9. Individuals unwilling to have blood taken 9 times during the study10. Individuals unwilling to comply with the study protocols11. Individuals with any other condition which in the opinion of the researchers could compromise the study.
Outcome results
None listed