Effect of daily ingestion of Bifidobacterium and dietary fiber on vascular endothelial function: a randomized, double-blind, placebo-controlled, parallel-group comparison study.

Bifidobacterium animalis subsp. lactis GCL2505 (GCL2505) improves the intestinal microbiota and reduces human visceral fat. This randomized, double-blind, placebo-controlled, parallel-group study was conducted to examine the effects of inulin, a prebiotic dietary fiber, and GCL2505 on vascular endothelial function in healthy subjects (n = 60). The test drink contained 2.0 g/100 g inulin and 1.0 × 1010 colony-forming units/100 g GCL2505 and was consumed daily for 12 weeks. Flow-mediated dilation was set as the primary endpoint. Subgroup analysis of vascular endothelial function demonstrated a significant increase in the change of flow-mediated dilation (%) from weeks 0 to 12 in the GCL2505 and inulin group (n = 24) compared with the placebo group (n = 23), while an improving trend in low-density lipoprotein cholesterol and plasminogen activator inhibitor-1 were confirmed. Our results indicated that the test drink had a positive effect on vascular endothelial function and related blood parameters.

[A literature review on the relationship between questionnaires for assessing minor health complaints and health status indices among Japanese people].

Objectives　Minor health complaints related to stress, mental health, sleep, and fatigue are closely associated with each other, and their deterioration may cause lifestyle diseases. The health status of people can be predicted through a questionnaire by exploring the relationship between their state of minor health complaints and objective health status indices. Therefore, we conducted a systematic review of the relationship between a questionnaire on the state of minor health complaints and health status indices among Japanese people who have a high level of stress, which they experience on a daily basis, using epidemiological literature. Additionally, we considered items for the questionnaire which were necessary for an index development.Methods　The PubMed database was searched for papers on "autonomic nervous system," "sleep disorders," "mental health and stress," and "fatigue," using keywords mentioned in previous studies on minor health complaints.　The extracted research papers were screened according to the following inclusion criteria: 1) the participants were healthy Japanese people; 2) descriptions included characteristics of the target population; 3) use of analytic epidemiological study design, intervention studies, and systematic reviews; 4) minor health complaints assessed by a questionnaire; 5) evaluation of the relationship between the questionnaires for minor health complaints and the health index; and 6) written in Japanese or English. Based on this, ten papers were adopted.Results　Of the 10 papers collected, one was a cohort study, three were case-control studies, and six were cross-sectional studies. The participants in five of them were working adults. Reports on three out of six questionnaires on stress, four out of seven on sleep, and all two on comprehensive health status showed significant associations between minor health complaints assessed by the questionnaires and the index for health status. The increase in responses about work-related stress from the questionnaire was associated with an increase in the "risk of developing depression" [odds ratio 2.96 (confidence interval: 1.04-8.42)]. Poor sleep quality was associated with an increase in "changes in autonomic index," "number of comorbidities and the rate of depression," and the "risk of work-related injuries." Moreover, the health score was associated with the "autonomic nervous system index".Conclusion　These results suggest that a questionnaire evaluating minor health complaints should include questions about "stress," "sleep quality," and "comprehensive health status." Since studies that appropriately adopted for risk of bias were limited, it is necessary to further examine these relationships by applying prospective studies such as cohort studies and intervention studies.

The effect of 24-week continuous intake of quercetin-rich onion on age-related cognitive decline in healthy elderly people: a randomized, double-blind, placebo-controlled, parallel-group comparative clinical trial.

Quercetin, a type of flavonoid, is believed to reduce age-related cognitive decline. To elucidate its potential function, we carried out a randomized, double-blind, placebo-controlled, parallel-group comparative clinical trial involving 24-week continuous intake of quercetin-rich onion compared to quercetin-free onion as a placebo. Seventy healthy Japanese individuals (aged 60 to 79 years old) were enrolled in this study. We examined the effect of quercetin-rich onion (the active test food) on cognitive function using the Mini-Mental State Examination, Cognitive Assessment for Dementia iPad version, and Neuropsychiatric Inventory Nursing Home version. The Mini-Mental State Examination scores were significantly improved in the active test food group (daily quercetin intake, 50 mg as aglycone equivalent) compared to the placebo food group after 24 weeks. On the Cognitive Assessment for Dementia iPad version for emotional function evaluation, we found that the scores of the active test food group were significantly improved, suggesting that quercetin prevents cognitive decline by improving depressive symptoms and elevating motivation. On the Neuropsychiatric Inventory Nursing Home version, we found significant effects on reducing the burden on study partners. Taking all the data together, we concluded that 24-week continuous intake of quercetin-rich onion reduces age-related cognitive decline, possibly by improving emotional conditions. Clinical trial register and their clinical registration number: This study was registered with UMIN (approval number UMIN000036276, 5 April 2019).

Safety and efficacy of adzuki bean extract in subjects with moderate to high LDL-C: a randomized trial.

The safety and efficacy of polyphenol-containing adzuki bean extract on lipid metabolism were evaluated in human subjects in an 8-week, randomized, double-blind, placebo-controlled, parallel intervention study. No adverse effects were observed in the participants receiving adzuki bean extract. The adzuki bean group showed a significant increase in the ΔHDL-C concentration compared with the placebo group after 4 weeks of intervention (3.76 ± 7.79 mg/dL vs. -0.08 ± 6.03 mg/dL), respectively, and both groups showed reduced ∆HDL-C concentrations, with the adzuki bean extract group showing a return to the baseline levels (0.36 ± 5.36 mg/dL) and the placebo group showing a decrease to below the baseline levels (-3.17 ± 7.79 mg/dL) at week 8. This short-term study represents the first step in establishing the practicality, safety, and plausibility of HDL-C maintaining effects of adzuki bean extract in human subjects.

Effects of dietary fiber with Bacillus coagulans lilac-01 on bowel movement and fecal properties of healthy volunteers with a tendency for constipation.

To elucidate the effects of Lilac LAB (Bacillus coagulans lilac-01 and okara [soy pulp] powder) on bowel movements/fecal properties, we conducted a double-blind placebo-controlled randomized trial with healthy Japanese volunteers with a tendency for constipation (n = 297). The subjects ingested 2 g/d placebo (okara powder) or test food (Lilac LAB, 1 × 10(8) CFU) once a day for 2 weeks. In the test group of functionally constipated subjects, the changes in the average scores of self-reported fecal size, sensation of incomplete evacuation, and defecation frequency were significantly improved compared to the placebo group (p < 0.05), and fecal color and odor tended to improve (p = 0.07). In the test food group of all subjects and among the non-functionally constipated subjects, the fecal size tended to improve compared to the placebo group (p = 0.06, p = 0.07, respectively). Lilac LAB was effective in improving bowel movements and fecal properties in functionally constipated persons.

Short-term effects of highly-bioavailable curcumin for treating knee osteoarthritis: a randomized, double-blind, placebo-controlled prospective study.

BACKGROUND: We previously developed a surface-controlled water-dispersible form of curcumin and named it Theracurmin(®) (Theracurmin; Theravalues, Tokyo, Japan). The area under the blood concentration-time curve of Theracurmin in humans was 27-fold higher than that of curcumin powder. We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis during 8 weeks of treatment. METHODS: Fifty patients with knee osteoarthritis of Kellgren-Lawrence grade II or III and who were aged more than 40 years were enrolled in this randomized, double-blind, placebo-controlled, prospective clinical study. Placebo or Theracurmin containing 180 mg/day of curcumin was administered orally every day for 8 weeks. To monitor adverse events, blood biochemistry analyses were performed before and after 8 weeks of each intervention. The patients' knee symptoms were evaluated at 0, 2, 4, 6, and 8 weeks by the Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale (VAS), the knee scoring system of the Japanese Orthopedic Association, and the need for nonsteroidal anti-inflammatory drugs. RESULTS: At 8 weeks after treatment initiation, knee pain VAS scores were significantly lower in the Theracurmin group than in the placebo group, except in the patients with initial VAS scores of 0.15 or less. Theracurmin lowered the celecoxib dependence significantly more than placebo. No major side effects were observed with Theracurmin treatment. CONCLUSION: Theracurmin shows modest potential for the treatment of human knee osteoarthritis.

Dietary Inflammatory Index, Sleep Duration, and Sleep Quality: A Systematic Review.

The inflammatory potential of the diet, as measured by the Dietary Inflammatory Index (DII®), has been repeatedly shown to be associated with various inflammatory markers and mental and physical health outcomes. Of specific importance, several cross-sectional studies revealed mixed results regarding the correlations between the DII and sleep outcomes. Hence, in the current paper, a systematic review that examines the associations between the DII, sleep duration, and sleep quality was performed. The PubMed database was systematically searched for studies published up to November 2023 following PRISMA guidelines. Only cross-sectional studies that assessed the DII, sleep duration, and sleep quality across healthy and unhealthy cohorts were included. Eleven and seven studies were included in the systematic review for sleep quality and duration, respectively. The results of the present systematic review show that pro-inflammatory diets may be associated with poor sleep outcomes (duration and quality); however, as the current literature is inconsistent and limited, further cross-sectional studies in larger cohorts are necessary to (i) explore this relationship to address this heterogeneity and (ii) explore populations that are more sensitive to diet-induced inflammation.

Internal Structure of Dietary Habits as a Restriction on Healthy Eating Policy in Japan.

Although promoting healthy eating is a policy objective, the manageability of dietary habits remains uncertain. Personal dietary patterns reflect many factors, some of which are relatively manageable for individuals whilst others are not. In this article, assuming that some sort of information about the manageability of dietary habits is contained in the observed patterns of food consumption, we focused on dietary patterns on their own. We introduced a statistical descriptive model for data from a food frequency questionnaire, estimated the strength of pairwise linkage between foodstuffs, and grouped foodstuffs by applying community detection to the networks of the estimated inter-food linkages. Those linkages represent the co-movement of pairs of food in consumption. Furthermore, we demonstrated an analysis of the relationship between mental health and dietary habits, considering the aspect of the manageability of dietary habits. Using an observational study in Japan, we obtained the following results: 115 foodstuffs were divided into three groups for both genders, but the compositions were different by gender; in the analysis of mental and physical health, some stress response items were associated with a dependence on some of those food groupings (e.g., "extremely tired" was negatively associated with a group containing tomatoes, cucumber, mandarin, etc., for female subjects). As the grouping of foodstuffs based on our estimation depicted an internal structure of dietary habit that a healthy eating policy could regard as a constraint, it follows that we should design such a policy along the same lines as that grouping.

Effects of Daily Consumption of Scallop Oil Prepared from Internal Organs of Japanese Giant Scallop (Patinopecten yessoensis) on Serum Lipid Composition and Its Safety: A Randomized, Double-blind, Placebo-controlled, Parallel Group Comparison Study.

Scallop oil (SCO) prepared from the internal organs of the Japanese giant scallop (Patinopecten yessoensis) contains eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and phospholipids (PL). It was previously shown that SCO consumption improves cholesterol and triacylglycerols (TG) contents in mice. The present study demonstrated the effects of daily SCO consumption (1.2 g/day, containing 376 mg of EPA, 63 mg of DHA, and 150 mg of PL) for 12 weeks in human subjects. In this randomized, doubleblind, placebo-controlled, parallel group comparison study, 70 Japanese subjects with serum TG levels ≥120 but < 200 mg/dL were recruited and randomly assigned to the SCO or placebo group. All subjects ingested six capsules per day for 12 weeks. We conducted medical interviews, body composition measurements, vital sign examinations, and blood sampling at weeks 0 (baseline), 4, 8, and 12, and measured peripheral blood flow at weeks 0 and 12. In the case of subjects with higher serum TG levels, SCO consumption decreased the changes in serum TG and malondialdehyde-low density lipoprotein (MDA-LDL) levels compared with the placebo group. Safety assessment revealed no medically significant changes due to continuous SCO consumption. The findings indicate that 1.2 g/day of SCO consumption may be beneficial for reducing serum TG and MDA-LDL levels in persons with higher TG levels.

Dietary inflammation, sleep and mental health in the United Kingdom and Japan: A comparative cross-sectional study.

Diet has been repeatedly shown to affect mental and sleep health outcomes. However, it is well known that there are cross-cultural differences in dietary practices as well as the prevalence of mental and sleep health outcomes. Given that the dietary inflammatory potential of diets has been linked to mental and sleep health outcomes, in the current study we sought to assess the inflammatory status of habitual diets and examine its relationship with mental and sleep health outcomes in both the United Kingdom and Japan. Our aim was to determine if the associations between the dietary inflammation index (DII) score and these health outcomes could elucidate any potential cross-cultural differences in health. Online survey data was collected from 602 participants (aged 18-40 years) in the United Kingdom (n = 288) and Japan (n = 314). Participants self-reported their dietary intakes, as well as current mental health and sleep patterns. The DII score was calculated (score range - 2.79 to 3.49) We found that although participants in the United Kingdom reported better overall mental wellbeing, participants in Japan reported less severe depression, anxiety and stress and better subjective sleep quality, less sleep disturbances and daytime dysfunction, despite sleeping shorter, and a better adherence to an anti-inflammatory diet. Moreover, across the United Kingdom and Japan, adherence to more anti-inflammatory diets predicted higher levels of subjective sleep quality, fewer sleep disturbances, less use of sleep medicine and less daytime dysfunction. In conclusion, there are several differences between mental and sleep health outcomes in the United Kingdom and Japan, which could be attributable to the inflammatory potential of respective regional diets. Future studies are warranted to examine the mental and sleep health benefits of adhering to anti-inflammatory traditional Japanese diets in clinical and subclinical cohorts.

Improvement of skin condition and intestinal microbiota via Heyndrickxia coagulans SANK70258 intake: A placebo-controlled, randomized, double-blind, parallel-group comparative study.

OBJECTIVE: Heyndrickxia coagulans SANK70258, a representative probiotic, is known for alleviating inflammation caused by cedar pollen, improving the intestinal environment and bowel movements. A previous study on consuming H. coagulans SANK70258 together with galactooligosaccharides showed a trend toward improvement in skin scaliness scores and subjective assessments of skin roughness. However, the effect of H. coagulans SANK70258 alone on the skin remains unclear. Thus, we aimed to re-evaluate the effects of the intake of H. coagulans SANK70258 alone on skin conditions and the intestinal environment through a clinical trial. METHODS: This placebo-controlled, double-blind clinical trial involved 80 Japanese women aged 30 to 65 with perceived skin roughness. Participants were divided into placebo and test groups. Over eight weeks, the test group consumed H. coagulans SANK70258, and its effects on skin condition and intestinal health were examined. RESULTS: The probiotic group showed significant intestinal improvements, with reduced fecal phenol levels (p = 0.044) and pH (p = 0.022), as well as enhanced skin lightness (L* value) (p = 0.040) and liver function tests. Metabolic analyses revealed decreases in fecal Nε-(carboxymethyl)lysine and plasma hydroxyproline, suggesting skin health benefits. There were also significant improvements in skin scaliness (p = 0.015) and bowel movement frequency (p = 0.032) in subgroup analysis. CONCLUSIONS: H. coagulans SANK70258 can improve skin health by improving the intestinal lining. This probiotic reduces the levels of intestinal putrefactive products and advanced glycation end-product levels in feces, suggesting that it may affect not only skin health but also systemic tissues such as the liver.

The Effect of Nutrients on Subjective Accomplishment at Work: Results from a Health Survey and a Single-Arm Dietary Intervention Study.

In Japan, many workers are exposed to chronic stress, sleep deprivation, and nutritional imbalance. They tend still to go to work when ill, leading to decreased work performance and productivity, which has become a major social problem. We conducted a human entry study with the aim of finding a link between these two factors and proposing an optimized diet, believing that a review of diet may lead to an improvement in labor productivity. In this study, we used subjective accomplishment (SA) as a measure of productivity. First, we compared nutrient intake between groups with high and low SA using data from a health survey of 1564 healthy male and female adults. Significant differences were found in the intake of 13 nutrients in males and 15 nutrients in females, including potassium, vitamin A, insoluble fiber, and biotin. Recommended daily intake of these nutrients was determined from survey data. Next, we designed test meals containing sufficient amounts of 17 nutrients and conducted a single-arm intervention study (registration code UMIN000047054) in Kameyama City, Mie Prefecture, Japan. Healthy working adults (males and females aged 20-79 years) were recruited and supplied with test meals, which were eaten once a day 5 days a week for 8 weeks. SA was significantly higher and daytime sleepiness (DS) was significantly lower after lunch on workdays in younger participants (under 60 years) when they ate the test meals as breakfast or lunch. Our results suggest that SA and DS, which change daily, are strongly influenced by the meal eaten before work, and that taking the 17 nutrients may help prevent presenteeism and improve labor productivity.

A new therapeutic approach using a schizophyllan-based drug delivery system for inflammatory bowel disease.

Antisense technologies for the targeted inhibition of gene expression could provide an effective strategy for the suppression of inflammation. However, the effective use of antisense oligonucleotides (ODN) has been limited because of several problems. Therefore, a delivery system for antisense ODNs that enhances antisense stability, while maintaining the specificity of antisense for its target RNA or DNA is needed. We have developed a delivery system for antisense ODN using schizophyllan (SPG), a polysaccharide that belongs to the ß-(1-3) glucan family. This system has several advantages enabling the effective suppression of targeted RNA or DNA: the SPG complex is stable in vivo and does not dissolve in the presence of deoxyribonuclease, and the SPG complex is effectively taken up into macrophages by phagocytosis through Dectin-1. Macrophage-migration inhibitory factor (MIF), which is mainly produced by macrophages has been shown to have a pathogenetic role in inflammatory bowel disease (IBD). We developed a technique to create an SPG complex that highly conformed to the antisense MIF. The administration of antisense MIF/SPG complex effectively suppressed MIF production and significantly ameliorated intestinal inflammation. Our result demonstrated a possible new therapeutic approach, i.e., the administration of antisense MIF/SPG complex, for the treatment of IBD.

The relation between habitual sleep duration and blood pressure values in Japanese male subjects.

BACKGROUND: Previous studies have demonstrated that sleep duration is closely associated with metabolic risk factors. However, the relationship between habitual sleep duration and blood pressure values in Japanese population has not been fully established. METHODS: We performed a cross-sectional study of 1,670 Japanese male subjects to clarify the relationship between habitual sleep duration and blood pressure values. The study subjects were divided into four groups (<6, 6-, 7-, and ≥8 h) according to their nightly habitual sleep duration. RESULTS: The rate of subjects with <6, 6-, 7-, and ≥8 h sleep duration was 12.0, 37.6, 38.2, and 12.2 %, respectively. Compared with the group with 7-h sleep duration (referent), the <6 and ≥8 h groups had significantly greater systolic and diastolic blood pressure values. The rate of hypertensive subjects, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, with sleep duration of <6, 6-, 7-, and ≥8 h was 13.4, 5.7, 7.5, and 13.8 %, respectively. Compared with the group with 7-h sleep duration (referent), the multivariate odds ratios (95 % confidence interval) of the groups with <6 and ≥8 h for hypertension was 2.43 (1.40-4.20, P < 0.01) and 2.28 (1.31-3.95, P < 0.01), respectively, adjusted for conventional cardiovascular risk factors. CONCLUSION: The present study demonstrates that both long and short habitual sleep duration were significantly associated with high blood pressure values and hypertension occurrence in Japanese male subjects.

Continuous intake of quercetin-rich onion powder may improve emotion but not regional cerebral blood flow in subjects with cognitive impairment.

Depression in later life is associated with dementia. Changes in motivated behavior are an important mechanism contributing to dysfunctional cognitive control in depression. Although continuous intake of quercetin-rich onion suppresses cognitive decline in aged people by improving their emotional condition, the effect of quercetin-rich onion on emotional condition in people living with cognitive impairment remains unclear. In this randomized, double-blind, placebo-controlled study of subjects with cognitive impairment, we found that subjects wrote more adjectives and adverbs per sentence on the Mini-Mental State Examination after intake of quercetin-rich onion powder than before intake, although regional cerebral blood flow on n-isopropyl-4-[123]iodoamphetamine hydrochloride single-photon emission computed tomography was not changed. In the EPM, mice that had received a quercetin-supplemented chow diet made a significantly increased number of exploratory head dips from the open arms of the maze. Moreover, the 3-methoxycarbonyl-2,2,5,5-tetramethyl-pyrrolidine-1-oxyl decay rate, reflecting redox activity, was increased in mice fed a quercetin-added diet. These results indicate that quercetin-rich onion may affect motivated behavior in subjects with cognitive impairment, for whom quercetin intake may preserve redox homeostasis in the brain.

The Relationship between Mental and Physical Minor Health Complaints and the Intake of Dietary Nutrients.

Presenteeism is a problem that needs to be solved urgently, both for individual workers and for society overall. In this report, we propose the concept of MHC, which refers to mild mental and physical complaints subjectively perceived by individuals that are not caused by illness. We also planned to examine what kind of physical and mental disorder MHC is and whether food is effective as a method of self-care for MHC. First, we conducted "the comprehensive survey to establish an integrated database of food, gut microbiome, and health information" (the "Sukoyaka Health Survey") and obtained data on psychosomatic disorders and intakes of dietary nutrients. As a result, through factor analysis and item response theory analysis, we found the following specific examples of MHC: lack of vigor, irritability, fatigue, and somatic complaints. In addition, analysis of the relationship between these four MHC levels and the intake dietary nutrients indicated that they are closely related and that MHC levels can be improved by consuming sufficient amounts of multiple nutrients.

Effects of Prebiotic Yeast Mannan on Gut Health and Sleep Quality in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study.

Human gut health is closely related to sleep. We aimed to evaluate the efficacy of yeast mannan (YM) in improving bowel habits and sleep quality, along with metabolomics in fecal samples. A total of 40 healthy adults (age range, 22-64 years) with discomfort in defecation were enrolled and randomly allocated to receive either YM (n = 20; 1.1 g/day) or placebo (n = 20) for four weeks. Participants recorded their defecation habits throughout the test periods. Sleep electroencephalogram (EEG) recording using an EEG device and fecal sampling were performed pre- and post-treatment. The YM group significantly increased defecation frequency and stool volumes compared to the placebo group. After 4 weeks of treatment, the non-REM sleep stage 3 (N3) duration in the YM group was significantly higher than that in the placebo group. YM ingestion significantly lengthened total time in bed (TIB) and significantly shortened N3 latency compared to placebo intake during the trial. The metabolomics analysis found a total of 20 metabolite differences between the YM and placebo groups. As a result of stepwise linear regression, changes in fecal propionate and gamma-aminobutyric acid (GABA) levels were identified as the primary factors explaining changes in TIB and N3 latency, respectively. Our findings suggest that the prebiotic YM could be beneficial to gut health and sleep quality.

UV-B radiation induces macrophage migration inhibitory factor-mediated melanogenesis through activation of protease-activated receptor-2 and stem cell factor in keratinocytes.

UV radiation indirectly regulates melanogenesis in melanocytes through a paracrine regulatory mechanism involving keratinocytes. Protease-activated receptor (PAR)-2 activation induces melanosome transfer by increasing phagocytosis of melanosomes by keratinocytes. This study demonstrated that macrophage migration inhibitory factor (MIF) stimulated PAR-2 expression in human keratinocytes. In addition, we showed that MIF stimulated stem cell factor (SCF) release in keratinocytes; however, MIF had no effect on the release of endothelin-1 or prostaglandin E2 in keratinocytes. In addition, MIF had no direct effect on melanin and tyrosinase synthesis in cultured human melanocytes. The effect of MIF on melanogenesis was also examined using a three-dimensional reconstituted human epidermal culture model, which is a novel, commercially available, cultured human epidermis containing functional melanocytes. Migration inhibitory factor induced an increase in melanin content in the epidermis after a 9-day culture period. Moreover, melanin synthesis induced by UV-B stimulation was significantly down-regulated by anti-MIF antibody treatment. An in vivo study showed that the back skin of MIF transgenic mice had a higher melanin content than that of wild-type mice after 12 weeks of UV-B exposure. Therefore, MIF-mediated melanogenesis occurs mainly through the activation of PAR-2 and SCF expression in keratinocytes after exposure to UV-B radiation.

Dietary supplementation of deoxyribonucleic acid derived from chum salmon milt improves liver function in healthy Japanese individuals: a placebo-controlled, randomised, double-blind, parallel-group clinical trial.

A placebo-controlled, randomised, double-blind, parallel-group comparative study was conducted to investigate the effect of continuous intake of salmon milt (SM) DNA for 12 weeks on the improvement of liver function in 50 healthy Japanese participants aged 30 to 70 years with alanine aminotransferase (ALT) levels of 25-87 U L-1 in men, 22-66 U L-1 in women, of BMI 22.1-29.4 kg m-2. Comparative analysis of hepatic functions and several other parameters, including anthropometric parameters in placebo and SM DNA administered groups, revealed no significant differences in serum ALT level. SM DNA significantly improved the liver-to-spleen (L/S) ratio, body weight, and BMI in the main group. In addition to these parameters, in the BMI < 25 kg m-2 subgroup, the leptin level was significantly reduced. No adverse reactions or abnormal changes, symptoms, or findings in the clinical examination after intake of the test food containing SM DNA were observed. Furthermore, no significant difference in uric acid levels between SM DNA and placebo groups indicated the safety of using SM DNA as a food supplement. These results demonstrated the potential fatty liver improvement and anti-obesity action of continuous intake of SM DNA for 12 weeks without any significant adverse effects.

Evaluation of the efficacy and safety of chum salmon milt deoxyribonucleic acid for improvement of hepatic functions: a placebo-controlled, randomised, double-blind, and parallel-group, pilot clinical trial.

The increased prevalence of nonalcoholic fatty liver disease (NAFLD) is a critical public health concern. Deoxyribonucleic acid (DNA) from chum salmon (Oncorhynchus keta) milt (salmon milt DNA; SM DNA), a by-product obtained during industrial processing of the pharmaceutical raw material protamine, ameliorates hepatosteatosis in animals. This randomised, double-blind, parallel-group comparative study evaluated the effects of SM DNA on hepatic function in healthy Japanese participants with slightly decreased liver function and high alanine aminotransferase level and body mass index. Fifty participants were included in the study. The participants were divided into the placebo (n = 24) and SM DNA (n = 26) groups and administered equal doses of placebo (dextrin) and SM DNA (530 mg day-1), respectively. No significant alleviating effects of SM DNA were observed on the primary (hepatic functions and liver-to-spleen ratio), and secondary (NAFLD fibrosis score, serum protein levels, blood glucose, blood lipids, inflammatory markers, adipokines, cytokines, fatigue scoring, and skin conditions) endpoints. Subsequently, a sex-based subgroup analysis revealed a significant improvement in the primary and secondary outcomes in males ingesting SM DNA compared with those in males who were administered placebo. However, no such effect was observed in females. Overall, this clinical study demonstrated the anti-obesity potential of SM DNA and suggested that SM DNA can benefit hepatic function in males.