A double-blind clinical safety study of noni fruit juice.

A safety study of TAHITIAN NONI Juice from Tahiti was conducted with ninety-six healthy volunteers. For 28 days, participants consumed one of four daily quantities of noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. All daily dose formulations were standardized to 750 mL by making up any volume differences with the placebo. Hematology, biochemistry, urinalysis, vital signs, and adverse events measurements were made at 0 (baseline), 2, and 4 weeks, as well as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements were also made for each volunteer during the pre-study screen and at week 6. During the trial, those in the noni groups experienced 20 to 50% fewer total adverse events than those in the placebo group. A marginally significant (P<0.1) reduction in the number of constant adverse events experienced by the volunteers was also found in the 300 mL noni juice group. A similar trend was observed in the other noni juice groups, as well. No other clinically significant differences between any of the groups were noted in the parameters and measurements of this study, nor was there evidence suggesting any adverse dose-related effects. The results of this study indicate that drinking up to 750 mL TAHITIAN NONI Juice per day is safe.