HealthyPhase 1NCT01424748
Clinical Trial of Tahitian Noni Juice Safety
A Phase 1 study testing Tahitian Noni Juice in people with Healthy, run by Tahitian Noni International, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tahitian Noni Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jun 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Tahitian Noni Juice, Placebo
- Keywords
- Noni juice, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tahitian Noni JuiceDietary supplement
noni fruit juice
PlaceboDietary supplement
Placebo juice
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo juice Receives: Dietary Supplement: Placebo |
| 30 mL Tahitian Noni Juice | Experimental | 30 mL Tahitian Noni Juice per day dose Receives: Dietary Supplement: Tahitian Noni Juice |
| 300 mL Tahitian Noni Juice | Experimental | 300 mL Tahitian Noni Juice per day Receives: Dietary Supplement: Tahitian Noni Juice |
| 750 mL Tahitian Noni Juice | Experimental | 750 mL Tahitian Noni Juice per day Receives: Dietary Supplement: Tahitian Noni Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events, electrocardiograms, vital signs, and clincial laboratory measurements recorded on day 0, 2 weeks, 4 weeks, and 6 weeks.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startApr 2003
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tahitian Noni International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TNO-BIBRA
- Investigators
- Christopher Mugglestone, MD, Principal investigator, TNO-BIBRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424748
- Sponsor's protocol ID
- BIBRA5124
- Status last verified
- Aug 2011
- First submitted
- 23 Feb 2011
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Double-blind, Three Dose Level, Parallel Group, Placebo Controlled Safety Study With Tahitian Noni Juice in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01424748
- Acronym / sponsor ID
- BIBRA5124
- Conditions
- Healthy
- Keywords
- Noni juice, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tahitian Noni International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TNO-BIBRA
- Study start
- Apr 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo juice |
| 30 mL Tahitian Noni Juice | Experimental | Dietary Supplement: Tahitian Noni Juice30 mL Tahitian Noni Juice per day dose |
| 300 mL Tahitian Noni Juice | Experimental | Dietary Supplement: Tahitian Noni Juice300 mL Tahitian Noni Juice per day |
| 750 mL Tahitian Noni Juice | Experimental | Dietary Supplement: Tahitian Noni Juice750 mL Tahitian Noni Juice per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tahitian Noni Juicenoni fruit juice | Dietary supplement | 30 mL Tahitian Noni Juice, 300 mL Tahitian Noni Juice, 750 mL Tahitian Noni Juice |
| PlaceboPlacebo juice | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Mugglestone, MD principal investigator
TNO-BIBRA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tahitian Noni Juice in people with Healthy, run by Tahitian Noni International, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011.