Clinical Trial of Tahitian Noni Juice Safety

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Tahitian Noni Juice

• Registration Number: NCT01424748
• Lead Sponsor: Tahitian Noni International, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2011-02-23
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-26
• Last Update Submitted: 2011-08-26
• Study First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Subjects were male or female, aged between 18 and 65 years inclusive.
• Subjects had a BMI of between 19 and 30 kg/m2 inclusive.
• Prior to study commencement, subjects signed and dated a witnessed informed consent form.
• Subjects had a satisfactory documented medical history during the 21 days prior to study commencement.
• Normal blood biochemistry, haematology, urinalysis and ECG were confirmed during the 21 days prior to study commencement.
• Subjects had negative virology profile (hepatitis B surface-antigen and hepatitis C virus antibody) confirmed during the 21 days prior to study commencement.
• Females of child-bearing potential had a documented negative urine pregnancy test and were not lactating or trying to become pregnant during the course of the study. They were using an adequate method of contraception. A female of non-childbearing potential was defined as one who had been post-menopausal for at least 12 months, had been surgically sterilised, or had a hysterectomy at least 3 months prior to study start.

Exclusion Criteria

• Subjects with any evidence or history of clinically significant hepatic or renal disorder, cardiovascular, respiratory, metabolic, immunological, neurological, psychiatric or gastrointestinal disease.
• Subjects with a history of asthma or allergic skin rash or other relevant allergic reaction.
• Subjects with known hypersensitivity or intolerance to drugs in general.
• Subjects with a history of alcohol abuse (more than 28 units per week for males and more than 21 units for females).
• Subjects who tested positive for hepatitis B surface-antigen and hepatitis C virus antibody.
• Subjects who had been on a course of prescribed drug treatment within 28 days of the study start that had not been approved by the Principal Investigator.
• Subjects who had taken any over the counter (OTC) drugs, vitamins, herbal remedies or used topically applied preparations within one week of study start unless the Principal Investigator had given approval.
• Subjects who smoked more than five cigarettes daily.
• Subjects who participated in a clinical trial or donated more than 500 ml of blood in the three months prior to study commencement.
• Female subjects who were pregnant, lactating or trying to become pregnant during the course of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo juice
30 mL Tahitian Noni Juice	Tahitian Noni Juice	30 mL Tahitian Noni Juice per day dose
300 mL Tahitian Noni Juice	Tahitian Noni Juice	300 mL Tahitian Noni Juice per day
750 mL Tahitian Noni Juice	Tahitian Noni Juice	750 mL Tahitian Noni Juice per day

Primary Outcome Measures

Name	Time	Method
Safety	6 weeks	Adverse events, electrocardiograms, vital signs, and clincial laboratory measurements recorded on day 0, 2 weeks, 4 weeks, and 6 weeks.