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

Tahitian Noni International

Status and phase: Completed; Phase 2

Conditions: DNA Damage

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Noni juice

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01677169

TNI-UIC-01

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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317 participants in 3 patient groups, including a placebo group

59 mL noni juice

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Noni juice

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

29.5 mL noni dose

Experimental group

Description:

Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days.

Treatment:

Dietary Supplement: Noni juice