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OpenTrials
Completed

NCT Number: NCT01677169

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

Completed

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Key information

Conditions

DNA Damage

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Illinois College of Medicine at Rockford

Rockford, Illinois, 61107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noni juice

Dietary Supplement

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

Dietary Supplement

Primary outcomes

  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 outcomes

  1. adverse events

    Time frame: 1 month

    Adverse health events

Sponsors and collaborators

Lead sponsor

Tahitian Noni International, Inc.

Industry

Collaborators

  • University of Illinois at Chicago

Registry information

Official study title

Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers

Important dates

Study start
2000
Primary completion
2005
Study completion
2006
First posted
Aug 31, 2012
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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