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

This study has been completed.
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier:
NCT01677169
First received: August 29, 2012
Last updated: August 30, 2012
Last verified: August 2012

August 29, 2012
August 30, 2012
September 2000
November 2005   (final data collection date for primary outcome measure)
LOOH and MDA-DNA adducts [ Time Frame: 1 month ] [ Designated as safety issue: No ]
LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.
Same as current
Complete list of historical versions of study NCT01677169 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Adverse health events
Same as current
Not Provided
Not Provided
 
Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Oxidative Damage of DNA Due to Cigarette Smoking.
  • 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
  • Dietary Supplement: Placebo
  • 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.
    Intervention: Dietary Supplement: Noni juice
  • 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.
    Intervention: 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.
    Intervention: Dietary Supplement: Noni juice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
August 2006
November 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01677169
TNI-UIC-01
Yes
Tahitian Noni International, Inc.
Tahitian Noni International, Inc.
University of Illinois at Chicago
Principal Investigator: Mian-ying Wang, MD University of Illinois at Chicago
Tahitian Noni International, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP