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Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers

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ClinicalTrials.gov Identifier: NCT01677169
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Tahitian Noni International, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Oxidative Damage of DNA Due to Cigarette Smoking. Dietary Supplement: Noni juice Dietary Supplement: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : September 2000
Primary Completion Date : November 2005
Study Completion Date : August 2006

Arm Intervention/treatment
Experimental: 59 mL noni juice
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.
Dietary Supplement: Noni juice
Ingestion of noni juice, a source of iridoids, daily for 30 days.
Other Names:
  • Tahitian Noni® Juice
  • Tahitian Noni® Original Bioactive
  • Thrive Adaptogenics Original
Placebo Comparator: Placebo
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.
Dietary Supplement: Placebo
Experimental: 29.5 mL noni dose
Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days.
Dietary Supplement: Noni juice
Ingestion of noni juice, a source of iridoids, daily for 30 days.
Other Names:
  • Tahitian Noni® Juice
  • Tahitian Noni® Original Bioactive
  • Thrive Adaptogenics Original



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 1 month ]
    Adverse health events



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677169


Locations
United States, Illinois
University of Illinois College of Medicine at Rockford
Rockford, Illinois, United States, 61107
Sponsors and Collaborators
Tahitian Noni International, Inc.
University of Illinois at Chicago
Investigators
Principal Investigator: Mian-ying Wang, MD University of Illinois at Chicago

Responsible Party: Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier: NCT01677169     History of Changes
Other Study ID Numbers: TNI-UIC-01
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012