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

NCT ID: NCT01677169

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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DNA Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Noni juice

Intervention Type DIETARY_SUPPLEMENT

Ingestion of noni juice, a source of iridoids, daily for 30 days.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Noni juice

Intervention Type DIETARY_SUPPLEMENT

Ingestion of noni juice, a source of iridoids, daily for 30 days.

Interventions

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Noni juice

Ingestion of noni juice, a source of iridoids, daily for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Tahitian Noni® Juice Tahitian Noni® Original Bioactive Thrive Adaptogenics Original

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role collaborator

Tahitian Noni International, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mian-ying Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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University of Illinois College of Medicine at Rockford

Rockford, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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TNI-UIC-01

Identifier Type: -

Identifier Source: org_study_id

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