NCT01677169

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

5.2 years

First QC Date

August 29, 2012

Last Update Submit

September 9, 2019

Conditions

DNA Damage

Outcome Measures

Primary Outcomes (1)

  • LOOH and MDA-DNA adducts

    LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.

    1 month

Secondary Outcomes (1)

  • adverse events

    1 month

Study Arms (3)

59 mL noni juice

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

29.5 mL noni dose

EXPERIMENTAL

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

Interventions

Noni juiceDIETARY_SUPPLEMENT

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

Also known as: Tahitian Noni® Juice, Tahitian Noni® Original Bioactive, Thrive Adaptogenics Original
29.5 mL noni dose59 mL noni juice
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois College of Medicine at Rockford

Rockford, Illinois, 61107, United States

Location

Study Officials

  • Mian-ying Wang, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

August 31, 2012

Study Start

September 1, 2000

Primary Completion

November 1, 2005

Study Completion

August 1, 2006

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

US(1)