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
  Purpose

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 Intervention Phase
Oxidative Damage of DNA Due to Cigarette Smoking.
Dietary Supplement: Noni juice
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Tahitian Noni International, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Adverse health events


Enrollment: 317
Study Start Date: September 2000
Study Completion Date: August 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tahitian Noni International, Inc.
ClinicalTrials.gov Identifier: NCT01677169     History of Changes
Other Study ID Numbers: TNI-UIC-01
Study First Received: August 29, 2012
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014