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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Tahitian Noni Juice

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo juice	Dietary supplement: Placebo; Placebo juice
Experimental: 30 mL Tahitian Noni Juice; 30 mL Tahitian Noni Juice per day dose	Dietary supplement: Tahitian Noni Juice; noni fruit juice
Experimental: 300 mL Tahitian Noni Juice; 300 mL Tahitian Noni Juice per day	Dietary supplement: Tahitian Noni Juice; noni fruit juice
Experimental: 750 mL Tahitian Noni Juice; 750 mL Tahitian Noni Juice per day	Dietary supplement: Tahitian Noni Juice; noni fruit juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse events, electrocardiograms, vital signs, and clincial laboratory measurements recorded on day 0, 2 weeks, 4 weeks, and 6 weeks.	6 weeks

Collaborators and Investigators

• Sponsor: Tahitian Noni International, Inc.
• Collaborators: TNO-BIBRA
• Investigators: Principal Investigator: Christopher Mugglestone, MD, TNO-BIBRA

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): June 1, 2003
• Study Completion (Actual): June 1, 2003

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 29, 2011

Study Record Updates

• Last Update Posted (Estimate): August 29, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Safety; Noni juice
• Other Study ID Numbers: BIBRA5124