Trial design

Volunteers

Main outcomes

Double blind, placebo-controlled clinical safety trial [4]

Healthy adults

No dose-related adverse events or negative effects on clinical chemistry and hematological measurements, urinalysis, electrocardiogram, blood pressure, heart rate, or body weight. Fewer adverse events than placebo group.

Double blind, placebo-controlled clinical trial [5]

Heavy cigarette smokers (>20 cigarettes/day)

26.9% - 30.8% reduction in mean plasma superoxide anion radicals (P < 0.001) and 24.5% - 27.3% mean reduction in plasma lipid hydroperoxides (P < 0.001).

Clinical trial, no placebo comparator reported [6]

Heavy cigarette smokers (>20 cigarettes/day)

44.9% average reduction in aromatic DNA adducts in peripheral blood lymphocytes (P < 0.001).

Double blind, placebo-controlled clinical trial [7]

Heavy cigarette smokers (>20 cigarettes/day)

20.3% - 25.6% reduction in mean total cholesterol (P < 0.05), 29.4% - 41.2% reduction in mean triglycerides (P < 0.05), 15.2% reduction in mean hs-CRP (P < 0.001), and 23.9% reduction in mean homocysteine (P < 0.05). Mean HDL increased from 49 to 57 mg/dL (P < 0.05).

Double blind, placebo-controlled clinical trial [8]

Heavy cigarette smokers (>20 cigarettes/day)

44.6% - 57.4% reduction in lipid peroxidation-derived DNA adducts in peripheral blood lymphocytes (P < 0.001).

Open-label clinical trial [9]

Adult (>40 years age) non-smokers with normal to mildly elevated cholesterol

No significant difference between pre- and post-trial total cholesterol, HDL or LDL levels.

Open-label, conventional treatment-controlled clinical trial [10]

Cervical spondylosis patients

60% of patients in noni group experienced pain relief and improvement in range of motion. Efficacy rate was not significantly different from conventional treatment (P > 0.05)

Open-label clinical trial [11]

Osteoarthritis patients

23.7% reduction in frequency (in days) of severe pain (P < 0.05) and 16.4% decrease in pain severity (P < 0.05). Improved psychological state and mood and improved mobility (P < 0.001).

Placebo-controlled clinical trial [12]

Highly trained athletes (middle and long-distance runners)

21% increase in mean time-to-fatigue (P < 0.05). 25% decrease in mean blood chemiluminescence/oxidation (P < 0.05).

Placebo-controlled clinical trial [13]

University athletes

Significant reduction in mean serum creatine kinase (from 209.8 to 148.1 IU/L, P = 0.001) after time-to-fatigue tests.

Double blind, placebo-controlled clinical trial [14]

Semi-professional cyclists

Increases in oxygen uptake at 50-Watt workload (from 15.2 to 17.4 mL/kg/min, P = 0.005) and VO2 max (from 51.5 to 55.0 mL/kg/min, P = 0.009)

Open-label clinical trial [15]

Healthy adults

Mean serum malondialdehyde levels declined from 4.81 to 3.90 nmol/mL (P < 0.01), mean serum IL-2 increased from 52.5 to 69.2 pg/mL (P < 0.05) and mean natural killer cell activity increased from 27.7% to 36.0% (P < 0.05).

Open-label trial [16]

Overweight or obese adults with grade 1 hypertension and impaired fasting glucose

Decrease in mean skin autofluorescence units, a measurement of advanced glycation end products, from 1.89 to 1.77 units (P < 0.05).

Open-label trial [17]

Adults with a body mass index greater than 25

Every participant in the trial experienced weight loss. Mean percent body fat decreased by 8.91% (P < 0.0001). Noni juice combined with other interventions.

Open-label prospective clinical trial in 3 parallel groups [18]

Obese adults (grade 3)

After 6 weeks of calorie restriction, the average loss of lean muscle mass was 3.1% - 4.1% in the two noni groups, whereas it was 8.5% in the control group (P = 0.0051). Maintenance of weight loss throughout the 6-week period was greater in the noni groups than in the calorie restriction only group.

Placebo-controlled clinical trial [19]

Post-menopausal women

Improved mental health score in SF-36 clinical survey (P = 0.05). Trend of slight increase in mean urinary deoxypyridinoline concentration. Attenuated hearing loss at 8000 Hz compared to the placebo group (P = 0.05).

Open-label clinical trial [20]

Hypertensive adults

Systolic blood pressure (BP) was reduced in all participants. Diastolic BP was reduced in nine participants. Mean systolic and diastolic BPs were reduced from 144 to 132 and from 83 to 76, respectively.

Open-label clinical trial with an untreated control group [21]

Adults with moderate to severe gingivitis/periodontitis

Decline in mean papillae bleeding index (from 2.25 to 1.01) was significantly greater than that of the control group (P = 0.01).