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Clinical Trial of Tahitian Noni Juice Safety

NCT01424748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2011-08-29

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Tahitian Noni Juice

noni fruit juice

DIETARY_SUPPLEMENT

Placebo

Placebo juice

Sponsors & Collaborators

  • TNO-BIBRA

    collaborator UNKNOWN

  • Tahitian Noni International, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Mugglestone, MD · TNO-BIBRA

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2003-06-30
Completion
2003-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424748 on ClinicalTrials.gov