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.

Study Overview

• Status: Completed
• Conditions: DNA Damage
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Noni juice

• Study Type: Interventional
• Enrollment (Actual): 317
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Rockford, Illinois, United States, 61107
      • University of Illinois College of Medicine at Rockford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LOOH and MDA-DNA adducts	LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	Adverse health events	1 month

Collaborators and Investigators

• Sponsor: Tahitian Noni International, Inc.
• Collaborators: University of Illinois at Chicago
• Investigators: Principal Investigator: Mian-ying Wang, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (ACTUAL): November 1, 2005
• Study Completion (ACTUAL): August 1, 2006

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (ESTIMATE): August 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TNI-UIC-01