Controlled comparison evaluation of the soothing effect of 3 cosmetic products on skin discomfort induced by an irritant chemical agent (capsaicin).

BACKGROUND: Sensitive skin is a highly prevalent problem. The objective of the study was to assess whether the tested products are effective and safe in terms of improving the symptoms of sensitive skin. METHODS: A clinical randomized split-face study was carried out on 24 healthy female subjects. Three cosmetic combinations were tested versus vehicle: product A (Solía Thermal Spring Water-TSW-from Cantabria, Spain + diatom algae-P. tricornutum-extract), product B (Solía TSW + diatom algae extract + Annona cherimola Fruit Extract) and product C (Solía TSW + diatom algae extract + Annona cherimola Fruit Extract + niacinamide). Prior to each application of the study Product (A, B, or C)/vehicle, 10% of aqueous solution of capsaicin to induce skin irritation was applied, mimicking the symptoms of sensitive skin. Stinging and burning sensations were evaluated at different time points. RESULTS: All three tested products A, B, and C showed to act better in calming the symptoms induced by capsaicin when compared to the vehicle. CONCLUSIONS: The tested products would be an interesting option for treating stinging and burning sensations in sensitive skin patients.

Standardized Grape (Vitis vinifera L.) Extract Improves Short- and Long-Term Cognitive Performances in Healthy Older Adults: A Randomized, Double-Blind, and Placebo-Controlled Trial.

Cognitive decline, a common consequence of aging, detrimentally affects independence, physical activity, and social interactions. This decline encompasses various cognitive functions, including processing speed, memory, language, and executive functioning. This trial aimed to investigate, with a double-blind, placebo-controlled clinical trial on 96 healthy older adults, the efficacy of once-daily 250 mg of a standardized grape (Vitis vinifera L.) juice extract (Cognigrape®) in improving short- and long-term cognitive functions. The results revealed significant improvements across multiple cognitive domains, notably immediate and delayed memory, visuospatial abilities, language, and attention, with improvements occurring within just 14 days, which continued to improve after 84 days of supplementation. The extract exhibited statistically significant enhancements in the Mini-Mental State Evaluation (MMSE), assessment of neuropsychological status (RBANS), "Esame Neuropsicologico Breve 2 (ENB-2), and Modified Bells Test (MBT) scores, with the latter test revealing a significant improvement in selective attention within just 90 min of the first dose. These positive results highlight the potential this natural grape extract has on improving cognitive function both acutely and chronically in a healthy aging population, which in turn supports a longer health span, at least cognitively.

Antiaging, Brightening, and Antioxidant Efficacy of Fermented Bilberry Extract (Vaccinium myrtillus): A Randomized, Double-Blind, Placebo-Controlled Trial.

Strategies for successful aging, including the use of food supplements, are part of the approach to support skin youthfulness. To demonstrate the efficacy of fermented bilberry extract (FBE) against skin aging and uneven complexion, a clinical trial was carried out on 66 subjects with visible "crow's feet" wrinkles, mild-to-moderate skin slackness, and uneven skin tone. The wrinkle depth, skin smoothness (Ra) and roughness (Rz), skin firmness (R0) and elasticity (R2), skin coloration (ITA°), and skin antioxidant capacity were measured before and after 28 (D28), 56 (D56), and 84 (D84) days of product use (either FBE or a placebo). These parameters were also integrated with a clinical evaluation, carried out by a dermatologist, and a self-assessment questionnaire to align the measured efficacy with the visual or perceived efficacy. At D84, the wrinkle depth had decreased by 10.6%, Ra had improved by 7.9%, Rz had decreased by 7.3%, R0 had improved by 13.3%, R2 had improved by 12.4%, and skin antioxidant capacity had increased by 20.8%. ITA° increased by 20.8% and was accompanied by a decrease in the skin's redness component by 16.8% and an increase in the lightness component by 2.2%. The variation of all the above-mentioned parameters was statistically significant between the FBE and PL groups. Our findings demonstrate the efficacy of FBE in improving skin aging and complexion evenness.

Pilot, open-label, randomized controlled clinical trial evaluating 4 oral hygiene regimens using a manual toothbrush, toothpaste, and mouthwash.

In this prospective pilot study, 84 patients with a history of poor oral hygiene were enrolled in an open-label, interventional, randomized controlled clinical trial. The aim was to provide preliminary clinical data on a new line of oral hygiene products containing a prebiotic and a paraprobiotic based on Lactobacillus plantarum. The recruitment rate and patient satisfaction were analyzed to estimate resources for the future primary study, and descriptive data on rebalancing of the oral microbiota were collected. The population was divided into 5 groups based on the products assigned to the patients: 1, delicate mint toothpaste (n = 20); 2, mint toothpaste (n = 12); 3, mint mouthwash (n = 20); 4, delicate mint toothpaste, mint mouthwash, and an antimicrobial toothbrush (n = 20); and 5, continued use of their usual oral care products and routine (control group; n = 12). The study duration was 28 days. All patients tolerated the products well, and there were no adverse events. The recruitment capability and procedures allowed for a realistic estimation for the future main trial. The products did not cause any changes in tooth color. The participants in group 4, who completed the treatment consisting of delicate mint toothpaste, mint mouthwash, and an antimicrobial toothbrush, reported the greatest reduction in gingival sensitivity (P ≤ 0.000; Wilcoxon signed rank test). Analysis with the Wilcoxon signed rank test revealed that all products induced a statistically significant decrease in plaque (P ≤ 0.002) and a reduction in gingival sensitivity (delicate mint toothpaste, P ≤ 0.005; mint toothpaste, P ≤ 0.015; and mint mouthwash, P ≤ 0.015). All products were effective in stabilizing the oral microbiota. The tested products showed an optimal safety profile and a statistically significant efficacy in reducing gingival sensitivity and plaque. They also stabilized the biodiversity of the oral microbiota, making it less susceptible to microbial fluctuations than the control group. Trial registration: ClinicalTrials.gov (NCT05999175).

Efficacy of a Food Supplement Containing Lactobacillus acidophilus LA14, Peptides, and a Multivitamin Complex in Improving Gastroesophageal Reflux Disease-Related Outcomes and Quality of Life of Subjects Showing Mild-to-Moderate Gastroesophageal Reflux Disease.

Dietary interventions represent an interesting alternative to pharmacological treatments for improving the quality of life (QoL) of subjects suffering from gastroesophageal reflux disease (GERD). This randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy of a food supplement (FS) containing a probiotic strain, bioactive peptides, and vitamins in relieving heartburn/dyspeptic symptoms in subjects with mild-to-moderate GERD. Fifty-six adult participants were randomly assigned to receive the placebo or the active FS for 28 days. Subjects were asked to record daily the frequency and intensity of heartburn episodes and the intake of over- the-counter (OTC) medications. GERD-QoL and self-assessment questionnaires were also completed every two weeks and at the end of the treatment, respectively. FS was effective in achieving a progressive and significant reduction of heartburn frequency and severity, with an intergroup significant difference at the end of the treatment period. FS group also reported a reduction in the OTC medication intake, whereas placebo administration did not modify the OTC intake. Results from the QoL and self-assessment questionnaires showed that FS administration achieved a progressive and statistically significant intragroup and intergroup improvement in the QoL score and a higher positive response with respect to the placebo treatment.

Low Molecular Weight Hyaluronic Acid Added to Six Specific Amino Acids in the Treatment of Striae Alba (SA): An Observational Study.

Striae distensae or stretch marks are a common complaint among women and can be distressing. The present study aimed to assess the efficacy of a mixture of low molecular weight hyaluronic acid and six amino acids when applied with a specific intradermal injection technique known as intra-mural fluid technique. A clinical study was carried out in 32 patients (with a dropout rate by 9.4%) with striae distensae alba (SA) in one or more of the following anatomical areas: breast, abdomen, inner thigh, trochanteric area, gluteal area, posterior supra-iliac area, and lumbar area. Product efficacy was assessed by the investigator using the Global Aesthetic Improvement Scale, while a Likert scale was used to evaluate to score the treatment tolerability and a QoL stretch marks questionnaire was used to investigate the patients' self-body image. The treatment was effective in improving the appearance of SA fifteen days after the second treatment and 6 months after the first treatment (and after a total of 4 treatments). The product efficacy and tolerability were also perceived by the patients during each treatment session. Our results suggest that the test treatment is a valid treatment option to decrease the appearance of SA. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors https://www.springer.com/00266.

A Randomized, Double-Blind, Placebo-Controlled Trial: Efficacy of Opuntia ficus-indica Prebiotic Supplementation in Subjects with Gut Dysbiosis.

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.

Hyaluronic Acid Treatment of Post-Extraction Tooth Socket Healing in Subjects with Diabetes Mellitus Type 2: A Randomized Split-Mouth Controlled Study.

The present study aimed to investigate the effect of HA in improving post-extraction socket healing in subjects with diabetes mellitus (DM) type 2. DM patients requiring bilateral extraction of the homologous teeth were visited at the C.I.R. Dental School, University of Turin. After the extractions, one site was randomly assigned to the test (T) group (postoperative application of HA), while the other site was assigned to the control group (C, no treatment). Patients were then followed after 3, 7, 14, and 21 days. Primary outcomes were the healing index and socket closure. The Mann-Whitney test or the Student's t-test was used for nonparametric or parametric distributed variables. The chi-square test was used if the estimated data in any given cell were >5, otherwise the Fisher test was adopted. A p < 0.05 was considered statistically significant. In total, 36 patients (n = 36) were enrolled in this study for a total of 72 extractions (n = 72). Sockets treated with HA showed significantly (p < 0.05) better healing index values at day 7 (p = 0.01) and at day 14 (p = 0.02) and significantly (p < 0.05) better socket closure values at day 3 (p = 0.04), day 7 (p = 0.001) and day 14 (p = 0.001) compared to the C group. Based on the clinical results, HA seems to be promising in improving the timing and the quality of post-extractive wound healing in DM patients. Further clinical research, as well as histological investigations, are required to confirm the results.

Equol and Resveratrol Improve Bone Turnover Biomarkers in Postmenopausal Women: A Clinical Trial.

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.

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.

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.

Influence of Sex on the Microbiota of the Human Face.

The role of the microbiota in health and disease has long been recognized and, so far, the cutaneous microbiota in humans has been widely investigated. The research regarded mainly the microbiota variations between body districts and disease skin states (i.e., atopic dermatitis, psoriasis, acne). In fact, relatively little information is available about the composition of the healthy skin microbiota. The cosmetic industry is especially interested in developing products that maintain and/or improve a healthy skin microbiota. Therefore, in the present work, the authors chose to investigate in detail the structure and composition of the basal bacterial community of the face. Ninety-six cheek samples (48 women and 48 men) were collected in the same season and the same location in central northern Italy. Bacterial DNA was extracted, the 16S rDNA gene was amplified by PCR, the obtained amplicons were subjected to next generation sequencing. The principal members of the community were identified at the genus level, and statistical analyses showed significant variations between the two sexes. This study identified abundant members of the facial skin microbiota that were rarely reported before in the literature and demonstrated the differences between male and female microbiota in terms of both community structure and composition.

Antioxidant Efficacy of a Standardized Red Orange (Citrus sinensis (L.) Osbeck) Extract in Elderly Subjects: A Randomized, Double Blind, Controlled Study.

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.

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.

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.

The Effect of a Probiotic Complex on the Gut-Brain Axis: A Translational Study.

BACKGROUND: The gut-brain axis refers to the network of connections that involve multiple biologic systems, allowing bidirectional communication between the gut and the brain. This communication is mainly mediated by gut microbiota, thanks to its ability to modulate several processes like the production of neurotransmitters. As such, keeping a balanced gut microbiota through probiotic intake could be a valid solution in supporting the right gut-brain communications. METHODS: A two-step in vitro screening of five different probiotic strains was carried out to select the best performers in the modulation of stress markers. A first selection on SK-N-DZ neuronal cell lines was performed to evaluate the inhibition of the epigenetic enzyme LSD1, promotion of GABA, and expression of serotonin. Three out of five strains were tested for their ability to promote serotonin synthesis in the Caco2 cell line. As a result, Limosilactobacillus reuteri PBS072 and Bifidobacterium breve BB077 were selected as the best performing strains. To confirm their effects in humans, a proof-of-concept trial was carried out to evaluate stress-related parameters for 28 days of product intake in a group of 30 stressed students. RESULTS: A significant improvement of cognitive functions, in terms of short-term memory, attention, and executive performance, as well as of psychophysiological markers, such as salivary cortisol level, skin conductance, sleep quality, and anxiety, were observed. CONCLUSIONS: According to the results, L. reuteri PBS072 and B. breve BB077 are potential probiotic candidates for improving stress resilience, cognitive functions, and sleep quality.

Efficacy Evaluation of a Cosmetic Product for the Periocular Area in Caucasian Women Aged Over 40 Years Old.

Purpose: The present study was aimed at evaluating the efficacy of a cosmetic product in improving the appearance of periocular skin. Patients and Methods: An open-label study on 40 female subjects showing clinical signs of skin aging in the periocular area (including bags under the eye and dark circles) was conducted. At day 0 and day 28 the bags under eye volume, dark circles color, skin texture, skin moisturization, skin elasticity, and skin radiance were measured. The instrumental measurements were integrated by clinical analysis carried out by a board-certified dermatologist and by a self-assessment questionnaire carried out by each subject participating in the study. Results: After 28 days of product use the volume of the bags under the eye was decreased by 6.8% (p = 0.005), the dark circle color red and blue component improved by 7.1% (p = 0.001) and 4.0% (p = 0.001), respectively, wrinkle depth and skin roughness decreased by 15.8% (p = 0.001) and 6.3% (p = 0.011), respectively, skin moisturization increased by 11.7% (p = 0.000), the skin distensibility decreased by 8.9% (p = 0.000), the overall skin elasticity increased by 10.4% (p = 0.000), and the skin radiance increased by 16.3% (p = 0.000). The instrumental measured effects were also confirmed by the clinical analysis of the dermatologist and the self-assessment questionnaire output. Conclusion: Conclusions: our results suggest that the test product is effective for periocular skin aesthetics (reduction of imperfections undermining the periocular area) and wellness.

Antioxidant and reduced skin-ageing effects of a polyphenol-enriched dietary supplement in response to air pollution: a randomized, double-blind, placebo-controlled study.

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.

In situ antioxidant activity of a dermo-cosmetic product: A randomized controlled clinical study.

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.

Corrigendum to "A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation".

[This corrects the article DOI: 10.1155/2016/4740907.].

Influence of equol and resveratrol supplementation on health-related quality of life in menopausal women: A randomized, placebo-controlled study.

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.

A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation.

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.