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

Sponsor
Tahitian Noni International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01677169
Collaborator
University of Illinois at Chicago (Other)
317
Enrollment
1
Location
3
Arms
71
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Noni juice
  • Dietary Supplement: Placebo
 Phase 2

Study Design

Study Type:
Interventional
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 :
Sep 1, 2000
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Aug 1, 2006

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LOOH and MDA-DNA adducts [1 month]

      LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.

    Secondary Outcome Measures

    1. adverse events [1 month]

      Adverse health events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tahitian Noni International, Inc.
    ClinicalTrials.gov Identifier:
    NCT01677169
    Other Study ID Numbers:
    • TNI-UIC-01
    First Posted:
    Aug 31, 2012
    Last Update Posted:
    Sep 11, 2019
    Last Verified:
    Sep 1, 2019

    Study Results

    No Results Posted as of Sep 11, 2019