A double-blind clinical safety study of noni fruit juice

Article · November 2009with423 Reads
Source: PubMed
A safety study of TAHITIAN NONI Juice from Tahiti was conducted with ninety-six healthy volunteers. For 28 days, participants consumed one of four daily quantities of noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. All daily dose formulations were standardized to 750 mL by making up any volume differences with the placebo. Hematology, biochemistry, urinalysis, vital signs, and adverse events measurements were made at 0 (baseline), 2, and 4 weeks, as well as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements were also made for each volunteer during the pre-study screen and at week 6. During the trial, those in the noni groups experienced 20 to 50% fewer total adverse events than those in the placebo group. A marginally significant (P<0.1) reduction in the number of constant adverse events experienced by the volunteers was also found in the 300 mL noni juice group. A similar trend was observed in the other noni juice groups, as well. No other clinically significant differences between any of the groups were noted in the parameters and measurements of this study, nor was there evidence suggesting any adverse dose-related effects. The results of this study indicate that drinking up to 750 mL TAHITIAN NONI Juice per day is safe.
    • Morinda citrifolia lowers the stress, and helps the response to some extent by elevating serotonin blood levels (Sathish Kumar, 2007). It is also found that Morinda citrifolia can be tolerated even at high dosage without any side effects (West et al., 2009). Moreover the recent findings indicate Morinda citrifolia acting as an inhibitor of MAO-A and MAO-B (Monoamine Oxidase) involve in synergistic effect from multiple active components (Shixin Deng and Brett, 2011).
    File · Data · Nov 2016 · Indian journal of dental research: official publication of Indian Society for Dental Research
    • Although there was a slight increase in ALT, which did not exceed the normal limits, there was a decrease in the hepatic inflammation caused by L. (L. ) amazonensis. Nevertheless , Noni toxicity still needs more studies, considering the controversial data in literature that sometimes show toxicity [38, 39], no toxicity [40][41][42]or even a liver protective effect [43]. The present work has proved the efficacy of Noni juice in reducing the parasite burden and lesion size.
    [Show abstract] [Hide abstract] ABSTRACT: The absence of an effective vaccine and the debilitating chemotherapy for Leishmaniasis demonstrate the need for developing alternative treatments. Several studies conducted with Morinda citrifolia have shown various biological activities, including antileishmanial activity, however its mechanisms of action are unknown. This study aimed to analyze the in vivo activity of M. citrifolia fruit juice (Noni) against Leishmania (Leishmania) amazonensis in C57BL/6 mice. M. citrifolia fruit juice from the Brazilian Amazon has shown the same constitution of other juices produced around the world and liquid chromatography–mass spectrometry analysis identified five compounds: deacetylasperulosidic acid, asperulosidic acid, rutin, nonioside B and nonioside C. Daily intragastric treatment with Noni was carried out after 55 days of L. (L.) amazonensis infection in C57BL/6 mice. Parasitic loads, cytokine and extracellular protein matrix expressions of the lesion site were analyzed by qPCR. Histopathology of the lesion site, lymph nodes and liver were performed to evaluate the inflammatory processes. Cytokines and biochemical parameters of toxicity from sera were also evaluated. The Noni treatment at 500 mg.kg⁻¹.day⁻¹ for 60 days decreased the lesion size and parasitic load in the footpad infected with L. (L.) amazonensis. The site of infection also showed decreased inflammatory infiltrates and decreased cytokine expressions for IL-12, TNF-α, TGF-β and IL-10. On the other hand, Noni treatment enhanced the extracellular matrix protein expressions of collagen IV, fibronectin and laminin in the infected footpad as well collagen I and II, fibronectin and laminin in the mock-infected footpads. No toxicity was observed at the end of treatment. These data show the efficacy of Noni treatment.
    Full-text · Article · Aug 2016
    • Noni juice was administered per oral (p.o.) in three different doses (2.5, 5 and 10 mL/kg). The doses of Noni juice for this study were adopted from a previous work by West et al. [16]. Imipramine powder (15 mg/kg, p.o.) [24] was dissolved in distilled water and administered orally during the CUMS procedure.
    [Show abstract] [Hide abstract] ABSTRACT: Aims: Noni juice is a natural herbal formulation containing Morinda citrifolia widely acclaimed as an immune system stimulant and mood enhancer. The aim of the study was to explore the antidepressant-and anxiolytic-like behavioural effects of Noni juice and to further evaluate the possible mechanisms of action in terms of biomarkers of oxidative stress on chronic unpredictable mild stress (CUMS) induced depressive model in mice. Methods: CUMS was used to induce behavioural deficits (depressive-and anxiety-like behaviours) and oxidative imbalance in mice. Mice were pretreated with Noni juice (2.5, 5 and 10 mL/kg, p.o) and thereafter subjected to different stress paradigms daily for a period of 21 days. Thereafter, sucrose preference test, behavioural despair tests, open field exploratory behaviour, Y-maze test as well as elevated plus maze, and light and dark maze tests were used to assess antidepressant-and anxiolytic-like behaviours, while standard biochemical protocols were used to assay for the biochemical alterations [Glutathione (GSH), superoxide dismutase (SOD), catalase (CAT) and malondialdehyde (MDA)]. Results: The results showed that Noni juice demonstrated significant (P < 0.05) inhibition of CUMS induced depressive-and anxiety-like behaviours in mice; by increasing the preference for sucrose, locomotor activity in the open field exploratory test, memory performance, decrease immobility in the behavioural despair tests and anxiety-related depressive behaviours. Furthermore, Noni juice decreased MDA concentration (33.2, 58.7 and 70.2%) in a dose-related manner. Moreover, Noni-juice significantly (P < 0.05) prevented the decrease in SOD and CAT activities, and increased GSH concentration in brain tissues. Conclusion: These data provides a rationale for evaluating Noni juice as a novel psychotropic agent against depressive-and anxiety-related behaviours and suggest that its mechanisms of action may be related to the modulation of endogenous antioxidant defense system.
    Full-text · Article · Jan 2016 · Indian journal of dental research: official publication of Indian Society for Dental Research
    • Nevertheless, clinical studies investigating health benefits of noni, other than diabetes, are slowly emerging. It is encouraging to note that systemic evaluations of long-term safety, determination of efficacious doses, and randomized, placebo-control trials are being conducted for standardized commercial preparations of NJ, such as the TNJ [67,68,96]. Yet, several other commercial noni products in the market lack rigorous scientific evaluations for potential health benefits.
    [Show abstract] [Hide abstract] ABSTRACT: Escalating trends of chronic diseases such as type-2 diabetes (T2D) have sparked a renewed interest in complementary and alternative medicine, including herbal products. Morinda citrifolia (noni) has been used for centuries by Pacific Islanders to treat various ailments. Commercial noni fruit juice has been marketed as a dietary supplement since 1996. In 2003, the European Commission approved Tahitian noni juice as a novel food by the Health and Consumer Protection Directorate General. Among noni’s several health benefits, others and we have demonstrated the anti-diabetic effects of fermented noni fruit juice in animal models. Unfortunately, noni’s exciting journey from Polynesian medicine to the research bench does not reach its final destination of successful clinical outcomes when translated into commercial products. Noni products are perceived to be safe due to their “natural” origin. However, inadequate evidence regarding bioactive compounds, molecular targets, mechanism of action, pharmacokinetics, long-term safety, effective dosages, and/or unanticipated side effects are major roadblocks to successful translation “from bench side to bedside”. In this review we summarize the anti-diabetic potential of noni, differences between traditional and modern use of noni, along with beneficial clinical studies of noni products and challenges in clinical translation of noni’s health benefits.
    Full-text · Article · Sep 2015
    • The inhibitory effect has shown to increase as the concentration of the extract increased. A double‑blinded controlled trial was conducted to test the toxicity of fruit and the results proved that up to 750 ml of the fruit juice taken per day was shown to have no toxic effects and was well‑tolerated by the humans[14]and reports also show widespread consumption of the fruit in several parts of the world for over several centuries without any known side‑effects.[15]Therefore, oral therapeutic anti‑fungal preparations can be formulated from higher concentrations of M. citrifolia fruit extracts to treat oral candidiasis, which can occur in patients with long term use of antibiotics, in immune‑compromised hosts and in patients undergoing chemotherapy.[16]As
    [Show abstract] [Hide abstract] ABSTRACT: Aim: The aim of this study was to investigate the anti-fungal activity of Morinda citrifolia fruit extract on Candida albicans. Materials and methods: Juice extract from M. citrifolia fruit was lyophilized and used in anti-fungal testing. Anti-fungal activity of M. citrifolia fruit extract against C. albicans was tested in vitro at various concentrations. The inhibitory effect of M. citrifolia extract on C. albicans was determined by agar culture and applied broth dilution test. Results: M. citrifolia extract at 1000 μg/ml concentration effectively inhibited the growth of C. albicans (16.6 ± 0.3) compared with the positive control - amphotericin B (20.6 ± 0.6). It was found to be a dose-dependent reaction. Conclusion: M. citrifolia fruit extract had an anti-fungal effect on C. albicans and the inhibitory effect varied with concentration.
    Full-text · Article · Mar 2014
    • Clinical depression is one of the major and important public health issues in 2007). It is also found that Morinda citrifolia can be tolerated even at high dosage without any side effects (West et al., 2009). Moreover the recent findings indicate Morinda citrifolia acting as an inhibitor of MAO-A and MAO-B (Monoamine Oxidase) involve in synergistic effect from multiple active components (Shixin Deng and Brett, 2011).
    Full-text · Article · Nov 2013 · Indian journal of dental research: official publication of Indian Society for Dental Research
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