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A Randomized, Double-Blind, Placebo-Controlled Trial: Efficacy of Opuntia ficus-indica Prebiotic Supplementation in Subjects with Gut Dysbiosis.
Mellai, M, Allesina, M, Edoardo, B, Cascella, F, Nobile, V, Spina, A, Amone, F, Zaccaria, V, Insolia, V, Perri, A, et al
Nutrients. 2024;(5)
Abstract
Gut dysbiosis refers to an imbalance in gut microbiota composition and function. Opuntia ficus-indica extract has been shown to modulate gut microbiota by improving SCFA production in vivo and gastrointestinal discomfort (GD) in humans. The aim of this study was to demonstrate the efficacy of OdiliaTM on gastrointestinal health by changing the microbial diversity of species involved in inflammation, immunity, oxidation, and the brain-gut-muscle axis. A randomized, double-blind clinical trial was conducted in 80 adults with gut dysbiosis. The intervention consisted of a 300 mg daily intake of OdiliaTM (n = 40) or maltodextrin as a placebo (n = 40), administered for 8 weeks. Intervention effect was evaluated using 16S metagenomics and GIQLI/GSAS scores at baseline, at 4 and 8 weeks. Eight weeks of OdiliaTM supplementation positively modulates gut microbiota composition with a significant reduction in the Firmicutes to Bacteroidetes ratio (p = 0.0012). Relative abundances of beneficial bacteria (Bacteroides and Clostridium_XIVa) were significantly increased (p < 0.001), in contrast to a significant reduction in pro-inflammatory bacteria (p < 0.001). Accordingly, GIQLI and GSAS scores revealed successful improvement in GD. OdiliaTM may represent an effective and well-tolerated treatment in subjects with gut dysbiosis.
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Effect of a Multi-Strain Probiotic Supplementation to Manage Stress during the COVID-19 Pandemic: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Clinical Trial.
Nobile, V, Puoci, F
Neuropsychobiology. 2023;(2):61-71
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Abstract
INTRODUCTION The COVID-19 pandemic strongly affected every aspect of the modern society, from health to socioeconomics, leading people to experience high levels of stress. METHODS A double-blind, cross-over, placebo-controlled clinical study was performed to investigate the ability of a food supplement containing two probiotic strains, Limosilactobacillus reuteri PBS072 and Bifidobacterium breve BB077, in supporting 33 healthy adults, working at a university, in stress management. The efficacy of the tested strains in influencing the stress response, in terms of mood and sleep behavior, was assessed using the following validated questionnaires: Profile of Mood State (POMS) and Pittsburgh Sleep Quality Index (PSQI). RESULTS Outcomes of the POMS and the PSQI demonstrated a significant reduction of the questionnaire's scores both versus baseline and placebo after 30 days of probiotic intake. CONCLUSIONS According to the results, the probiotic food supplement investigated showed a remarkable effect on stress management by improving the quality of sleep and the mood.
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Equol and Resveratrol Improve Bone Turnover Biomarkers in Postmenopausal Women: A Clinical Trial.
Corbi, G, Nobile, V, Conti, V, Cannavo, A, Sorrenti, V, Medoro, A, Scapagnini, G, Davinelli, S
International journal of molecular sciences. 2023;(15)
Abstract
Estrogen deficiency is a major cause of loss of postmenopausal bone mineral density (BMD). This study aimed to evaluate the effects of equol and resveratrol on bone turnover biomarkers in postmenopausal women. Sixty healthy postmenopausal women were randomly assigned to receive 200 mg fermented soy containing 10 mg equol and 25 mg resveratrol or a placebo for 12 months. Whole-body BMD and bone turnover biomarkers, such as deoxypyridinoline (DPD), tartrate-resistant acid phosphatase 5b (TRACP-5b), osteocalcin, and bone-specific alkaline phosphatase (BAP), were measured at baseline and after 12 months of treatment. At the end of treatment, DPD, osteocalcin, and BAP significantly improved in the active group (p < 0.0001 for all) compared to the placebo group. Conversely, TRACP-5b levels were unaffected by supplementation (p = 0.051). Statistically significant changes in the concentrations of DPD (p < 0.0001), osteocalcin (p = 0.0001), and BAP (p < 0.0001) compared to baseline were also identified. Overall, the intervention significantly increased BMD measured in the whole body (p = 0.0220) compared with the placebo. These data indicate that the combination of equol and resveratrol may positively modulate bone turnover biomarkers and BMD, representing a potential approach to prevent age-related bone loss in postmenopausal women.
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Antioxidant Efficacy of a Standardized Red Orange (Citrus sinensis (L.) Osbeck) Extract in Elderly Subjects: A Randomized, Double Blind, Controlled Study.
Nobile, V, Pisati, M, Cestone, E, Insolia, V, Zaccaria, V, Malfa, GA
Nutrients. 2022;(20)
Abstract
The world population is rapidly aging. This should cause us to reflect on the need to develop a new nutritional approach to mitigate the accumulation of reactive oxygen species (ROS)-induced damage. A randomized, double blind, controlled study was carried out on 60 elderly male and female subjects. Product efficacy was measured before and after 2 and 8 weeks of product intake. The reduced (GSH) and oxidized (GSSG) glutathione concentrations in the erythrocytes and the reactive oxygen metabolites (d-ROMs) hematic concentration were measured to assess the antioxidant efficacy. The tumor necrosis factor-alpha (TNF-α) levels in the serum were measured to assess the anti-inflammatory effectiveness. The wellbeing was assessed by Short Form Health Survey (SF-36) questionnaire (male) and by Menopause Rating Scale (MRS) (female). Blood, urine analysis and electrocardiography (ECG) were carried out to assess the product's safety. The results showed that GSH/GSSG ratio increased by 22.4% and 89.0% after 2 and 8 weeks of product intake. Serum TNF-α levels decreased by 2.5% after 8 weeks of product intake. The SF-36 QoL and the MRS questionnaire outputs indicate, preliminarily, a positive effect of the extract intake in ameliorating the wellbeing of both male and female subjects. The product was well-tolerated. Our findings suggest that the test product has antioxidant and anti-inflammatory efficacy and has a positive effect on the wellbeing of elderly female and male subjects.
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Photoprotective and Antiaging Effects of a Standardized Red Orange (Citrus sinensis (L.) Osbeck) Extract in Asian and Caucasian Subjects: A Randomized, Double-Blind, Controlled Study.
Nobile, V, Burioli, A, Yu, S, Zhifeng, S, Cestone, E, Insolia, V, Zaccaria, V, Malfa, GA
Nutrients. 2022;(11)
Abstract
The increase in solar ultraviolet radiation (UVR) that reaches the Earth's surface should make us reflect on the need to develop new approaches in protecting the skin from UVR exposure. The present study aims to evaluate the photoprotective and antiaging efficacy of a red orange extract (100 mg/day) in both Asian and Caucasian subjects. A randomized, double-blind, controlled study was carried out in 110 Asian and Caucasian subjects. Product efficacy was measured as follows: (1) the photoprotective effect was measured by the minimal erythema dose (MED) assessment; (2) the efficacy in decreasing the UVA+B-induced skin redness was measured by colorimetry; (3) the antioxidant efficacy was measured by the ferric-reducing antioxidant power (FRAP) and the malondialdehyde (MDA) assay; and (4) skin moisturization, skin elasticity, skin radiance, the intensity of melanin staining, transepidermal water loss (TEWL), and wrinkles were measured to assess the antiaging efficacy. The intake of the product for 56 days was effective in improving the skin reaction to UV exposure; in increasing the skin antioxidant capacity as well as in decreasing UVA-induced lipid peroxidation; in increasing the skin moisturization, skin elasticity, and skin radiance; and in decreasing TEWL, the intensity of melanin staining inside dark spots, and wrinkle depth. Our results suggest that the test product is effective in counteracting both the harmful effects of UVR exposure and aging signs.
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Antioxidant and reduced skin-ageing effects of a polyphenol-enriched dietary supplement in response to air pollution: a randomized, double-blind, placebo-controlled study.
Nobile, V, Schiano, I, Peral, A, Giardina, S, Spartà, E, Caturla, N
Food & nutrition research. 2021
Abstract
BACKGROUND Air pollution exposure is one of the major threats to skin health and accelerates skin ageing mainly through oxidative stress mechanisms. Since it is difficult to minimize skin exposure to air pollutants, especially in urban areas, strategies to protect the skin are needed. Plant phenolic compounds have been found to be effective in attenuating cellular oxidative stress and inflammation induced by different air pollutants and a dietary approach based on these compounds could provide an efficient protection measure. OBJECTIVE Here we investigated the efficacy of a commercially available polyphenol-enriched dietary supplement (Zeropollution®) in reducing pollution-induced oxidative stress and in improving different skin parameters related to skin ageing of Caucasian and Asian subjects exposed to air pollution. Zeropollution is composed of four standardized herbal extracts: Olea europaea leaf, Lippia citriodora, Rosmarinus officinalis, and Sophora japonica. DESIGN A double-blind randomized, parallel group study was carried out on 100 outdoor workers living in a polluted urban European area (Milan) to assess the efficacy of the dietary supplement. The total antioxidant capacity on saliva (FRAP), the oxidative damage on skin (lipoperoxides content), skin moisturization (corneometer), transepidermal water loss (tewameter), skin radiance and colour (spectrophotometer), skin elasticity (cutometer), skin sebum content (sebumeter), and the skin roughness (image analysis) were measured. RESULTS Both inter-group and intra-group analysis proved that the dietary supplement improved all clinical and biochemical-monitored parameters, in both Caucasian and Asian individuals. Some of the positive effects such as decreased wrinkle depth, increased elasticity and firmness, improved skin moisturization and transepidermal water loss, and reduced dark spots pigmentation were statistically significant as early as 2 weeks of product consumption. CONCLUSIONS The results of the study indicate reduced oxidative stress-induced skin damage in both Asian and Caucasian women living in a polluted urban area. Therefore, the oral intake of this four-plant based supplement could be considered a complementary nutrition strategy to avoid the negative effects of environmental pollution exposure.
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In situ antioxidant activity of a dermo-cosmetic product: A randomized controlled clinical study.
Ribet, V, Nobile, V, Rossi, AB
Experimental dermatology. 2019;(11):1219-1226
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Ultraviolet light enhances the generation of reactive oxygen species that are responsible for skin photoageing. The aim of this randomized, vehicle- and active-controlled double-blind, intra-individual monocentric study was to evaluate in situ the antioxidant activity of a dermo-cosmetic product in photoaged skin. Twenty healthy volunteers had defined skin areas randomized to receive a topical product containing 3 antioxidants (pre-tocopheryl® , retinaldehyde and glycylglycine ole-amide), its vehicle and a positive antioxidant control cream. The products were applied daily for 30-day period. The skin areas were exposed to a controlled dose of UVA rays, and the skin oxidative status was evaluated 4 and 24 hours post-UVA exposure at D0 (basal value) and after 15 and 30 days of product application. Skin layers were collected by stripping, and antioxidant capacity was measured using the ferric reducing ability of a plasma assay. Lipid peroxidation (LPO) was assessed using the malonyldialdehyde test. The tested product significantly improved the skin antioxidant capacity after 15 and 30 days and significantly decreased the basal level of the skin LPO. The skin LPO level significantly decreased 4 and 24 hours after UVA exposure at 15 and 30 days. These findings were comparable to positive control treated sites and were significantly different from the vehicle and untreated sites. This minimally invasive methodology enabled a quantitative evaluation of potent antioxidant activity in situ in the stratum corneum reflecting real-life skin conditions and confirming the benefits of the topical application of a product containing 3 antioxidants in the prevention of UVA-induced oxidative damage.
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Influence of equol and resveratrol supplementation on health-related quality of life in menopausal women: A randomized, placebo-controlled study.
Davinelli, S, Scapagnini, G, Marzatico, F, Nobile, V, Ferrara, N, Corbi, G
Maturitas. 2017;:77-83
Abstract
OBJECTIVE This study was designed to evaluate the effects of equol and resveratrol supplementation on health-related quality of life (HRQoL) in otherwise healthy menopausal women with hot flashes, anxiety and depressive symptoms. METHODS Sixty recently menopausal women aged 50-55 years were randomized in a 12-week, placebo-controlled trial to receive 200mg of fermented soy containing 10mg of equol and 25mg of resveratrol (1 tablet/day). The primary outcome was the change in score on the Menopause Rating Scale (MRS), used to evaluate the severity of age-/menopause-related complaints. Additional outcome measures included the subject-reported score on the Hamilton Rating Scale for Depression (HAM-D) and Nottingham Health Profile (NHP), which was used specifically to assess sleep quality. RESULTS The symptoms assessed by the MRS improved during treatment in the active group. Comparison between placebo and treatment groups revealed statistically significant improvement in particular for dryness of vagina (-85.7%) (p<0.001), heart discomfort (-78.8%; p<0.001) and sexual problems (-73.3%; p<0.001). On the HAM-D significant improvements at week 12 were seen in work and activities (-94.1%) (p<0.001). Subjects treated with equol and resveratrol also had significant differences in the sleep domain of the NHP (p<0.001). CONCLUSION These findings provide evidence that 12 weeks of dietary supplementation with equol and resveratrol may improve menopause-related quality of life in healthy women.
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A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.
Mezzasalma, V, Manfrini, E, Ferri, E, Sandionigi, A, La Ferla, B, Schiano, I, Michelotti, A, Nobile, V, Labra, M, Di Gennaro, P
BioMed research international. 2016;2016:4740907
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A controlled balance between the healthy and harmful intestinal bacterial species is fundamental for maintaining a healthy gut. Recent studies have shown a correlation between microbiota imbalance and onset of IBS-related symptoms, however the available data remains limited and inconclusive. The aim of this trial was to assess the efficacy of multispecies probiotic supplementation on the gut microbiota of 150 patients diagnosed with IBS. Participants were randomly divided into three groups receiving either one of two probiotic mixtures or the placebo for 90 days. Stool samples were analysed and both symptom and quality of life questionnaires were recorded. The multispecies probiotic supplementation administered in this study demonstrated significant amelioration of IBS symptoms and improvement in quality of life. This supports the role of the gut microbiome in IBS and the potential role of multispecies probiotics in managing this disorder.
Abstract
Background and Aim. The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated. Methods. A randomized, double-blind, three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups (F_1, F_2, and F_3). Each group received a daily oral administration of probiotic mixtures (for 60 days) F_1 or F_2 or placebo F_3, respectively. Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics. Results. The percentage of responders for each symptom was higher in the probiotic groups when compared to placebo group during the treatment period (t60) and was maintained quite similar during the follow-up period (t90). Fecal analysis demonstrated that probiotics of the formulations increased during the times of treatment only in fecal DNA from subjects treated with F_1 and F_2 and not with F_3, and the same level was maintained during the follow-up period. Conclusions. Multispecies probiotic supplementations are effective in IBS-C subjects and induce a different assessment in the composition of intestinal microbiota. This clinical study is registered with the clinical study registration number ISRCTN15032219.
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Clinical efficacy of a cosmetic treatment by Crescina(®) human follicle stem cell on healthy males with androgenetic alopecia.
Buonocore, D, Nobile, V, Michelotti, A, Marzatico, F
Dermatology and therapy. 2013;(1):53-62
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INTRODUCTION Androgenetic alopecia (AGA) is the most common cause of hair loss among males, characterized by progressive thinning of the scalp hairs and defined by various patterns. The main factors underling hair loss in AGA are genetic predisposition and increased sensitivity of the hair follicles to androgens, leading to a shortening of the anagen phase. In the present study, the authors investigated the efficacy of a commercially available cosmetic lotion, Crescina(®) HFSC (human follicle stem cell; Labo Cosprophar AG, Basel, Switzerland), in promoting hair growth and in decreasing hair loss. METHODS A placebo-controlled, randomized trial was carried out on healthy males suffering from alopecia grade II to IV. Anagen rate and hair resistance to traction (pull test) were assessed after 2 and 4 months of treatment using phototricogram and pull test technique. RESULTS Crescina(®) HFSC applied for 4 months was effective in promoting hair growth and in decreasing hair loss. After 2 and 4 months of treatment, the anagen rate was increased by 29.6% and 46.8%, respectively [corrected]. Hair resistance to traction was decreased by 29.6% and 46.8%, respectively. CONCLUSIONS The present study demonstrated the positive effect of Crescina(®) HFSC in modulating the activity of the hair follicle and promoting hair growth.