NCT01424748

Clinical Trial of Tahitian Noni Juice Safety

A Single Centre, Double-blind, Three Dose Level, Parallel Group, Placebo Controlled Safety Study With Tahitian Noni Juice in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Tahitian Noni International, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital signs, and adverse events measurements will be made at 0 (baseline), 2, and 4 weeks, as well as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements will also be made for each volunteer during the pre-study screen and at week 6.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tahitian Noni Juice	noni fruit juice
DIETARY_SUPPLEMENT	Placebo	Placebo juice

Timeline

• Start date: 2003-04-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2011-08-29
• Last updated: 2011-08-29