Clinical Trial of Tahitian Noni Juice Safety

This study has been completed.
Sponsor:
Collaborator:
TNO-BIBRA
Information provided by:
Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier:
NCT01424748
First received: February 23, 2011
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: Tahitian Noni Juice
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Single Centre, Double-blind, Three Dose Level, Parallel Group, Placebo Controlled Safety Study With Tahitian Noni Juice in Healthy Subjects

Further study details as provided by Tahitian Noni International, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, electrocardiograms, vital signs, and clincial laboratory measurements recorded on day 0, 2 weeks, 4 weeks, and 6 weeks.


Enrollment: 96
Study Start Date: April 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: TAHITIAN NONI Juice
Experimental: 300 mL Tahitian Noni Juice
300 mL Tahitian Noni Juice per day
Dietary Supplement: Tahitian Noni Juice
noni fruit juice
Other Name: TAHITIAN NONI Juice
Experimental: 750 mL Tahitian Noni Juice
750 mL Tahitian Noni Juice per day
Dietary Supplement: Tahitian Noni Juice
noni fruit juice
Other Name: TAHITIAN NONI Juice

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424748

Sponsors and Collaborators
Tahitian Noni International, Inc.
TNO-BIBRA
Investigators
Principal Investigator: Christopher Mugglestone, MD TNO-BIBRA
  More Information

No publications provided

Responsible Party: Brett West, Tahitian Noni Intl.
ClinicalTrials.gov Identifier: NCT01424748     History of Changes
Other Study ID Numbers: BIBRA5124
Study First Received: February 23, 2011
Last Updated: August 26, 2011
Health Authority: United Kingdom: Department of Health

Keywords provided by Tahitian Noni International, Inc.:
Noni juice
Safety

ClinicalTrials.gov processed this record on October 21, 2014