DNA DamagePhase 2NCT01677169
Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers
A Phase 2 study testing Noni juice in people with DNA Damage, run by Tahitian Noni International, Inc. at 1 site in United States.
Trial summary
The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Damage
- What is being tested?
- Noni juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Aug 2006
- Phase
- Phase 2
- 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
- 18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial.
Who cannot join
- concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois College of Medicine at Rockford
Rockford, Illinois, 61107
About this study
Official title: Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers
The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.
- Conditions
- DNA Damage
- Being tested
- Noni juice, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noni juiceDietary supplement
Also called Tahitian Noni® Juice, Tahitian Noni® Original Bioactive, Thrive Adaptogenics Original
Ingestion of noni juice, a source of iridoids, daily for 30 days.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 59 mL noni juice | Experimental | Ingestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days. Receives: Dietary Supplement: Noni juice |
| Placebo | Placebo comparator | Ingestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days. Receives: Dietary Supplement: Placebo |
| 29.5 mL noni dose | Experimental | Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days. Receives: Dietary Supplement: Noni juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
LOOH and MDA-DNA adducts
LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.
Measured: 1 month
Secondary outcomes (1)
adverse events
Adverse health events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startSep 2000
- Primary completionNov 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA DamageStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tahitian Noni International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois Chicago
- Responsible party
- Sponsor
- Investigators
- Mian-ying Wang, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677169
- Sponsor's protocol ID
- TNI-UIC-01
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2012
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers
- ClinicalTrials.gov ID
- NCT01677169
- Acronym / sponsor ID
- TNI-UIC-01
- Conditions
- DNA Damage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Tahitian Noni International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Illinois Chicago
- Study start
- Sep 2000
- Primary completion
- Nov 2005 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 31 Aug 2012 (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.
The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 59 mL noni juice | Experimental | Dietary Supplement: Noni juiceIngestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIngestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days. |
| 29.5 mL noni dose | Experimental | Dietary Supplement: Noni juiceIngestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial.
Key exclusion criteria (1 listed)
- concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins
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 |
|---|---|---|
| Noni juiceAlso: Tahitian Noni® Juice, Tahitian Noni® Original Bioactive, Thrive Adaptogenics OriginalIngestion of noni juice, a source of iridoids, daily for 30 days. | Dietary supplement | 29.5 mL noni dose, 59 mL noni juice |
| Placebo | Dietary supplement | Placebo |
Primary outcome
LOOH and MDA-DNA adducts
Time frame: 1 month
LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.
1 secondary outcome
adverse events
Time frame: 1 month
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 11 Sep 2019.
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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.
Mian-ying Wang, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Noni juice in people with DNA Damage, run by Tahitian Noni International, Inc. at 1 site in United States.
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 1 inclusion and 1 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
LOOH and MDA-DNA adducts (time frame: 1 month). 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 11 Sep 2019.