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

DNA Damage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677169
• Other study ID #: TNI-UIC-01
• Status: Completed
• Phase: Phase 2
• Start date: September 2000
• Est. completion date: August 2006

Study information

• Verified date: September 2019
• Source: Tahitian Noni International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: August 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• DNA Damage

Intervention

Dietary Supplement:
• Noni juice
Ingestion of noni juice, a source of iridoids, daily for 30 days.
• Placebo

Locations

Country	Name	City	State
United States	University of Illinois College of Medicine at Rockford	Rockford	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Tahitian Noni International, Inc.	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LOOH and MDA-DNA adducts	LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.	1 month
Secondary	adverse events	Adverse health events	1 month