Clinical Trial of Tahitian Noni Juice Safety

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tahitian Noni Juice

Dietary Supplement

noni fruit juice

Placebo

Dietary Supplement

Placebo juice

Primary outcomes

Safety

Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Tahitian Noni International, Inc.

Industry

Collaborators

TNO-BIBRA

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Aug 29, 2011
Registry last updated: Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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