Safety and Efficacy of N-SORB®, a Proprietary KD120 MEC Metabolically Activated Enzyme Formulation: A Randomized,Double-Blind,Placebo-Controlled Study

Abstract

Background: Enzymes are crucial for all aspects of metabolic function. Digestive enzymes from natural sources have been credited with beneficial effects in the digestion and absorption of food. N-SORB is a novel KD120 multienzyme complex (MEC) of metabolically activated enzymes composed of proteases, amylases, lipases, alpha-galactosidase, and glucoamylase from natural sources. These enzymes are encapsulated in a SK713 SLP (non-GMO soy lecithin phospholipid) absorption technology (Prodosome^®).

Objective: This randomized, double-blind placebo-controlled investigation assessed the safety and efficacy of N-SORB KD120 MEC in healthy male and female volunteers on various parameters of the blood, immunity, body composition, physical health, and quality of life following a 90-day intervention.

Methods: Forty-six male and female (mean age: 25.8?±?12.1?years) healthy volunteers were randomly assigned to receive either N-SORB (1?mL, twice daily) or placebo for 90 consecutive days. Complete blood count, as well as blood glucose, liver enzymes, and lipid profile were assessed pre- and post-intervention. Serum cytokine levels were determined by using a Bio-Plex Pro Human Cytokine 8-plex assay and enzyme linked immunosorbent assay (ELISA). Whole body composition analysis was performed by dual-energy x-ray absorptiometry (DEXA) to determine body fat mass, lean mass, and android and gynoid fat. Body weight, blood pressure, and physical health were assessed. Changes in quality of life were examined using the World Health Organization Quality of Life–abbreviated version and sleep quality was assessed using the 24-item Pittsburgh Sleep Quality Index (PSQI) questionnaire. Adverse events were monitored before, during, and after completion of the study.

Results: Of the 46 subjects enrolled, a total of 40 subjects successfully completed the study. Compared to placebo, changes in blood cell counts including hematocrit, hemoglobin, mean corpuscular volume, platelets, and lymphocytes provide evidence of some improvement. Quality of life (QOL) parameters showed a small but significant improvement in the N-SORB group. A significant increase was observed in aspartate aminotransferase level in the placebo group at the end of 90?days of treatment; however, no increase was observed in the N-SORB group. No significant changes in blood urea nitrogen, serum creatinine, alkaline phosphatase, alanine aminotransferase, and lipid profile were observed between the placebo and treatment groups before and following intervention. No adverse effects were reported.

Conclusions: This randomized, double blind, placebo-controlled clinical study demonstrates that short-term intervention with N-SORB improves the QOL and PSQI in healthy volunteers and did not significantly alter cardiometabolic parameters, lipid profile, or body composition.     

Effects of l-Carnitine Supplementation on Serum Inflammatory Factors and Matrix Metalloproteinase Enzymes in Females with Knee Osteoarthritis: A Randomized,Double-Blind,Placebo-Controlled Pilot Study

Objective: Considering the importance of inflammation in the pathogenesis of osteoarthritis (OA) and induction of pain, this study was aimed to investigate the effect of L-carnitine supplementation on serum inflammatory mediators and OA-associated pain in females with knee OA.

Methods: In this clinical trial, 72 females with mild to moderate knee osteoarthritis started the study, divided into 2 groups to receive 750 mg/day L-carnitine (n = 36) or placebo (n = 36) for 8 weeks. Serum levels of Interleukine-1β (IL-1β), high-sensitivity C-reactive protein (hs-CRP), matrix metalloproteinases (MMPs)-1 and -13, and visual analog scale (VAS) for pain were assessed before and after supplementation. Data were analyzed by t test, Wilcoxon signed rank test, Mann-Whitney U test, and analysis of covariance.

Results: Only 69 patients (33 in the L-carnitine group and 36 in the placebo group) completed the study. L-Carnitine supplementation decreased serum IL-1β and MMP-1 levels significantly (p = 0.001 and p = 0.021, respectively); however, serum hs-CRP and MMP-13 levels did not change significantly (p > 0.05). In the placebo group, serum IL-1β levels increased significantly (p = 0.011), whereas other studied biomarkers did not change significantly. The mean VAS score decreased significantly in the L-carnitine and placebo groups by 52.67% and 21.82%, respectively (p < 0.001). Significant differences were only observed between the 2 groups in serum IL-1β (p < 0.001) and MMP-1 (p = 0.006) levels and mean VAS score (p = 0.002) after adjusting for baseline values and covariates.

Conclusion: Despite observed beneficial effects of short-term supplementation of L-carnitine in decreasing serum inflammatory mediators and improving pain in knee OA patients, further studies are needed to achieve concise conclusions.     

Effect of a Perioperative Nutritional Supplementation with Oral Impact® in Patients undergoing Hepatic Surgery for Liver Cancer: A Prospective,Placebo-Controlled,Randomized, Double-Blind Study

Perioperative nutrition with supplements containing l-arginine, ω3-polyunsaturated fatty acids, and nucleotides could boost liver function recovery, immune response, and resistance to infection after hepatic resection. We conducted a placebo-controlled, randomized, double-blind study to assess the effect of a perioperative nutritional supplementation with Oral Impact® in patients undergoing hepatic surgery for liver cancer. Treatment was given three times daily for 7 days before and 3 days after surgery. Primary outcome was factor V, 3 days after surgery. Thirty-five patients (placebo: 17; Oral Impact: 18) were included. Five patients (placebo: three; Oral Impact: two) were not operated and five (placebo: two; Oral Impact: three) did not undergo hepatic resection. Factor V (mean ± SD) was 70 ± 27% and 79 ± 25% (P = 0.409) 3 days after surgery and 90 ± 30% and 106 ± 16% (P = 0.066) 5 days after surgery, in placebo and Oral Impact groups, respectively. There were no significant differences between groups on other outcomes assessing liver function recovery (bile production, γ-glutamyl transferase, α-fetoprotein), immune response (CD3, CD4, CD8 cells, CD4/CD8 ratio, natural killer cells, B lymphocytes), number of infections, and tolerance. A 10-day perioperative nutritional supplementation with Oral Impact does not improve hepatic function, immune response, and resistance to infection in patients undergoing hepatic surgery for liver cancer.     

A Pilot,Randomized, Placebo-Controlled,Double-Blind Phase 0/Biomarker Study on Effect of Artepillin C–Rich Extract of Brazilian Propolis in Frequent Colorectal Adenoma Polyp Patients

Objective: Breastfeeding reduces the risk of asthma and respiratory infections in infants. Since respiratory infections are associated with reduced pulmonary function in adolescents, pulmonary function impairment may be carried into adulthood. Our aim was to determine whether a history of having been breastfed as an infant is a determinant of adult pulmonary function.

Methods: We analyzed data from a general population sample of residents of Erie and Niagara Counties between September 1995 and December 1999. We calculated forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC) prediction equations and used multiple linear regression models to study the association between having been breastfed as an infant and percentage predicted FEV₁ (FEV₁%) and percentage predicted FVC (FVC%) after adjustment for covariates.

Results: Of 2305 subjects, 62% reported having been breastfed. After controlling for age, gender, weight, smoking status, pack-years of smoking, eosinophil counts and dietary factors, there was no association between having been breastfed (yes/no) and FEV₁% or FVC% (regression coefficients 0.0049, p = 0.46 and 0.0055, p = 0.43, respectively).

Conclusions: We did not find a strong or consistent association between having been breastfed as an infant and pulmonary function in adulthood.     

The Study of Mental and Resistance Training (SMART) Study—Resistance Training and/or Cognitive Training in Mild Cognitive Impairment: A Randomized,Double-Blind,Double-Sham Controlled Trial

BackgroundMild cognitive impairment (MCI) increases dementia risk with no pharmacologic treatment available.MethodsThe Study of Mental and Resistance Training was a randomized, double-blind, double-sham controlled trial of adults with MCI. Participants were randomized to 2 supervised interventions: active or sham physical training (high intensity progressive resistance training vs seated calisthenics) plus active or sham cognitive training (computerized, multidomain cognitive training vs watching videos/quizzes), 2–3 days/week for 6 months with 18-month follow-up. Primary outcomes were global cognitive function (Alzheimer's Disease Assessment Scale-cognitive subscale; ADAS-Cog) and functional independence (Bayer Activities of Daily Living). Secondary outcomes included executive function, memory, and speed/attention tests, and cognitive domain scores.ResultsOne hundred adults with MCI [70.1 (6.7) years; 68% women] were enrolled and analyzed. Resistance training significantly improved the primary outcome ADAS-Cog; [relative effect size (95% confidence interval) −0.33 (−0.73, 0.06); P < .05] at 6 months and executive function (Wechsler Adult Intelligence Scale Matrices; P = .016) across 18 months. Normal ADAS-Cog scores occurred in 48% (24/49) after resistance training vs 27% (14/51) without resistance training [P < .03; odds ratio (95% confidence interval) 3.50 (1.18, 10.48)]. Cognitive training only attenuated decline in Memory Domain at 6 months (P < .02). Resistance training 18-month benefit was 74% higher (P = .02) for Executive Domain compared with combined training [z-score change = 0.42 (0.22, 0.63) resistance training vs 0.11 (−0.60, 0.28) combined] and 48% higher (P < .04) for Global Domain [z-score change = .0.45 (0.29, 0.61) resistance training vs 0.23 (0.10, 0.36) combined].ConclusionsResistance training significantly improved global cognitive function, with maintenance of executive and global benefits over 18 months.     

Does Single or Combined Caffeine and Taurine Supplementation Improve Athletic and Cognitive Performance without Affecting Fatigue Level in Elite Boxers? A Double-Blind,Placebo-Controlled Study

In previous studies, the effect of single or combined intake of caffeine (CAF) and taurine (TAU) on exercise performance was investigated. However, the potential synergistic effect on physical and cognitive performance after fatigue induced by anaerobic exercise is unknown. The effects of single and combination CAF and TAU supplementation on the Wingate test in elite male boxers and to evaluate balance, agility and cognitive performance after fatigue are being investigated for the first time in this study. Twenty elite male boxers 22.14 ± 1.42 years old were divided into four groups in this double-blind, randomized crossover study: CAF (6 mg/kg of caffeine), TAU (3 g single dose of taurine), CAF*TAU (co-ingestion of 3 g single dose of taurine and 6 mg/kg of caffeine) and PLA (300 mg maltodextrin). The findings are as follows: co-ingestion of CAF*TAU, improved peak (W/kg), average (W), minimum (W) power, time to reach (s), and RPE performances compared to the PLA group significantly (p < 0.05). Similarly, it was determined that a single dose of TAU, created a significant difference (p < 0.05) in peak power (W/kg), and average and minimum power (W) values compared to the CAF group. According to the balance and agility tests performed after the Wingate test, co-ingestion of CAF*TAU revealed a significant difference (p < 0.05) compared to the PLA group. In terms of cognitive performance, co-ingestion of CAF*TAU significantly improved the neutral reaction time (ms) compared to the TAU, CAF and PLA groups. As a result, elite male boxers performed better in terms of agility, balance and cognitive function when they consumed a combination of 6 mg/kg CAF and 3 g TAU. It has been determined that the combined use of these supplements is more effective than their single use.     

Does the Time of Day Play a Role in the Acute Effect of p-Synephrine on Fat Oxidation Rate during Exercise in Women? A Randomized,Crossover and Double-Blind Study

p-Synephrine is deemed a safe and effective substance to increase fat utilization during exercise of low-to-moderate intensity in men but not in women. Additionally, the existence of a diurnal variation in substrate utilization has been documented during exercise with enhanced fat oxidation in the evening compared with early morning. However, it remains unknown whether there is an interaction between the effect of p-synephrine and the time of the day on fat oxidation during exercise. This study aimed to evaluate the effect of the acute ingestion of 3 milligram of p-synephrine per kilogram of body mass (mg/kg) on fat oxidation during exercise of increasing intensity when the exercise is performed in the morning vs. the evening. Using a randomized, double-blind, placebo-controlled experimental design, 16 healthy and active women performed four identical exercise trials after the ingestion of 3 mg/kg of p-synephrine and 3 mg/kg of a placebo (cellulose) both in the morning (8–10 am) and in the evening (5–7 pm). In the exercise trials, the substances were ingested 60 min before an incremental test on a cycle ergometer with 3 min stages at workloads from 30 to 80% of maximal oxygen uptake (VO₂max). Substrate oxidation rates were measured by indirect calorimetry. In each trial, the maximum rate of fat oxidation (MFO) and the intensity that elicited MFO (Fatmax) were measured. A two-way analysis of variance (time-of-the day × substance) was used to detect differences among the trials. With the placebo, MFO was 0.25 ± 0.11 g/min in the morning and 0.24 ± 0.07 g/min in the evening. With p-synephrine, MFO was 0.26 ± 0.09 g/min in the morning and 0.21 ± 0.07 g/min in the evening. There was no main effect of substance (p = 0.349), time of day (p = 0.186) and the substance × time of day (p = 0.365) on MFO. Additionally, Fatmax was reached at a similar exercise intensity with the placebo (41.33 ± 8.34% VO₂max in the morning and 44.38 ± 7.37% VO₂max in the evening) and with p-synephrine (43.33 ± 7.24% VO₂max in the morning and 45.00 ± 7.43% VO₂max in the evening), irrespective of the time of day with no main effect of substance (p = 0.633), time of day (p = 0.191), or interaction (p = 0.580). In summary, the acute intake of 3 mg/kg of p-synephrine before exercise did not increase MFO and Fatmax, independently of the time of day, in female athletes. This indicates that the time of day is not a factor explaining the lack of effectiveness of this substance to enhance fat oxidation during aerobic exercise in women.     

A Preliminary Study of New Parents,Sleep Disruption,and Driving: A Population at Risk?

Background Drowsy driving is estimated to be a causal factor in 2–16 % of vehicular crashes. Several populations are reported to be at high risk for drowsy driving accidents, including shift workers, teenage drivers, medical residents, and pilots. Although new parents are known to have significant sleep disruption, no study has investigated vehicular accidents or near miss accidents in this population. Methods A preliminary cross-sectional, anonymous survey of parents who had given birth within the previous 12 months. Participants were asked about their sleep, including validated measures of sleep disruption, their driving patterns, and information about near miss traffic accidents and actual crashes. Results Overall, 72 participants were enrolled. A large proportion of participants had poor sleep including approximately 30 % with daytime sleepiness, 60 % with poor daytime function and two-thirds with poor sleep quality. The mean sleep duration was only 6.4 h. Although most participants drove <100 miles per week, 22.2 % reported at least one near miss accident and 5.6 % reported a crash. Sleep problems were more common in those with near miss accidents and actual crashes than in those without. Of note, poor sleep quality was associated with a sixfold increase in near miss accidents even after accounting for other factors. Conclusion Poor sleep is common in new parents and we provide preliminary evidence that sleep disruption in this population is associated with near miss motor vehicle accidents. Drowsy driving results in thousands of unnecessary serious injuries and fatalities each year; raising public awareness that new parents are a high-risk group is important.     

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

Background

Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals.

Methods

Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively.

Results

Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates.

Conclusions

A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research.Key words: informed consent, cohort study, ethics, genetics, randomization     

A Population-based Case–Control Study of Urinary Arsenic Species and Squamous Cell Carcinoma in New Hampshire,USA

Background: Chronic high arsenic exposure is associated with squamous cell carcinoma (SCC) of the skin, and inorganic arsenic (iAs) metabolites may play an important role in this association. However, little is known about the carcinogenicity of arsenic at levels commonly observed in the United States.Objective: We estimated associations between total urinary arsenic and arsenic species and SCC in a U.S. population.Methods: We conducted a population-based case–control SCC study (470 cases, 447 controls) in a U.S. region with moderate arsenic exposure through private well water and diet. We measured urinary iAs, monomethylarsonic acid (MMA), and dimethylarsinic acid (DMA), and summed these arsenic species (ΣAs). Because seafood contains arsenolipids and arsenosugars that metabolize into DMA through alternate pathways, participants who reported seafood consumption within 2 days before urine collection were excluded from the analyses.Results: In adjusted logistic regression analyses (323 cases, 319 controls), the SCC odds ratio (OR) was 1.37 for each ln-transformed microgram per liter increase in ln-transformed ΣAs concentration [ln(ΣAs)] (95% CI: 1.04, 1.80). Urinary ln(MMA) and ln(DMA) also were positively associated with SCC (OR = 1.34; 95% CI: 1.04, 1.71 and OR = 1.34; 95% CI: 1.03, 1.74, respectively). A similar trend was observed for ln(iAs) (OR = 1.20; 95% CI: 0.97, 1.49). Percent iAs, MMA, and DMA were not associated with SCC.Conclusions: These results suggest that arsenic exposure at levels common in the United States relates to SCC and that arsenic metabolism ability does not modify the association.Citation: Gilbert-Diamond D, Li Z, Perry AE, Spencer SK, Gandolfi AJ, Karagas MR. 2013. A population-based case–control study of urinary arsenic species and squamous cell carcinoma in New Hampshire, USA. Environ Health Perspect 121:1154–1160; http://dx.doi.org/10.1289/ehp.1206178     

Intakes of Vitamin A,C, and E,and β-Carotene Are Associated With Risk of Cervical Cancer: A Case-Control Study in Korea

Cervical cancer is one of the most common gynecological malignancies in Korea, although the incidence has been declining in recent years. This study explored whether antioxidant vitamin intakes influenced the risk of cervical cancer. The association between antioxidant vitamin intakes and cervical cancer risk was calculated for 144 cervical cancer cases and 288 age-matched, hospital-based controls using unconditional logistic regression models. Cases reported statistically lower mean dietary intakes of vitamin A, β -carotene, and vitamin C than did controls. Total intakes of vitamins A and E, which included both dietary and supplement intake, were also lower in cases. Those patients in the highest quartiles of dietary vitamin A, β -carotene, and vitamin C intakes had statistically significantly lower cervical cancer risks than those in the lowest quartiles for vitamin A, β -carotene, and vitamin C: odds ratio (OR) = 0.36 [95% confidence interval (CI) = 0.19–0.69), OR = 0.48 (CI = 0.26–0.88), and OR = 0.36 (CI = 0.18–0.69), respectively. Total intakes of vitamins A, C, and E were strongly inversely associated with cervical cancer risk: OR = 0.35 (CI = 0.19–0.65), OR = 0.35 (CI = 0.19–0.66), and OR = 0.53 (CI = 0.28–0.99), respectively. The findings support a role for increased antioxidant vitamin intake in decreasing the risk of cervical cancer. These associations need to be assessed in large prospective studies with long-term follow-up.     

Effects of an Iron or Iron and Vitamin D–Fortified Flavored Skim Milk on Iron Metabolism: A Randomized Controlled Double-Blind Trial in Iron-Deficient Women

Objectives: Iron deficiency anemia and vitamin D deficiency are considered global pandemics. The aim of this study was to determine whether the consumption of a dairy product fortified with iron and vitamin D, compared to the equivalent with only added iron, exerts an additional effect on iron metabolism in iron-deficient menstruating women.

Methods: The design was a randomized, placebo-controlled, double-blind, parallel-group trial of 16 weeks’ duration. Subjects were randomized into 2 groups that consumed, as part of their usual diet, 500 mL/day of an iron (n = 54) or iron- and vitamin D–fortified (n = 55) flavored skim milk. At baseline and monthly, dietary intake, body weight, and hematological and iron metabolism biomarkers were determined. Serum 25-hydroxyvitamin D was analyzed at baseline and weeks 8 and 16. Data were analyzed by analysis of variance (ANOVA) of repeated measures for time and Time×Group interaction effects.

Results: A total of 109 volunteers completed the study. Calcium and iron intakes increased during the intervention (p < 0.001 for both groups). Serum 25-hydroxyvitamin D significantly increased in Fe + D group during the assay (p < 0.001) and at week 16 it was higher compared to the Fe group (p < 0.05). Serum ferritin, serum transferrin, mean corpuscular volume, mean corpuscular hemoglobin, and red blood cell distribution width showed significant time effects but no Time×Group interaction. Higher values of erythrocytes (p = 0.01), hematocrit (p = 0.05), and hemoglobin (p = 0.03) at week 8 were observed in the Fe + D group compared to the Fe group.

Conclusion: Iron-fortified flavored skim milk does not improve iron status in iron-deficient menstruating women. However, vitamin D fortification slightly enhances erythropoiesis and iron status.     

In Vitro Bioaccessibility,Human Gut Microbiota Metabolites and Hepatoprotective Potential of Chebulic Ellagitannins: A Case of Padma Hepaten? Formulation

Chebulic ellagitannins (ChET) are plant-derived polyphenols containing chebulic acid subunits, possessing a wide spectrum of biological activities that might contribute to health benefits in humans. The herbal formulation Padma Hepaten containing ChETs as the main phenolics, is used as a hepatoprotective remedy. In the present study, an in vitro dynamic model simulating gastrointestinal digestion, including dialysability, was applied to estimate the bioaccessibility of the main phenolics of Padma Hepaten. Results indicated that phenolic release was mainly achieved during the gastric phase (recovery 59.38%–97.04%), with a slight further release during intestinal digestion. Dialysis experiments showed that dialysable phenolics were 64.11% and 22.93%–26.05% of their native concentrations, respectively, for gallic acid/simple gallate esters and ellagitanins/ellagic acid, in contrast to 20.67% and 28.37%–55.35% for the same groups in the non-dialyzed part of the intestinal media. Investigation of human gut microbiota metabolites of Padma Hepaten and pure ChETs (chebulinic, chebulagic acids) established the formation of bioactive urolithins (A, B, C, D, M5). The fact of urolithin formation during microbial transformation from ChETs and ChET-containing plant material was revealed for the first time. Evaluation of the protective effect of ChETs colonic metabolites and urolithins on tert-butyl hydroperoxide (t-BHP)-induced oxidative injury in cultured rat primary hepatocytes demonstrated their significant reversion of the t-BHP-induced cell cytotoxicity, malonic dialdehyde production and lactate dehydrogenase leakage. The most potent compound was urolithin C with close values of hepatoprotection to gallic acid. The data obtained indicate that in the case of Padma Hepaten, we speculate that urolithins have the potential to play a role in the hepatic prevention against oxidative damage.     

The Impact of Written Emotional Disclosure on Cancer Caregivers’ Perceptions of Burden,Stress, and Depression: A Randomized Controlled Trial

Spousal cancer caregivers’ emotional and relational health can become compromised over time due to ongoing challenges related to the cancer experience. This warrants a call for the assessment of interventions aimed at improving aspects of caregiver well-being. The current study employed a randomized controlled trial to determine whether emotional disclosure via the use of expressive writing improved spousal cancer caregivers’ perceived caregiver burden, stress, and depression. Participants (N = 64) were assigned to one of the two disclosure conditions: expressive disclosure or benefit finding—or to a time-management control condition. Participants completed three at-home writing sessions at one-week intervals. Results indicated that written forms of emotional disclosure might improve burden, stress, and depression contingent on writing condition. Specifically, both forms of emotional disclosure outperformed the control condition in reducing caregivers’ depression. The control condition outperformed treatments in reducing caregiver stress. Finally, posttest caregiver burden was significantly lower than pretest burden across all writing conditions.

This trial was registered with clinicaltrials.gov, ID: NCT02339870     

A Prospective Study of Young Females’ Sexual Subjectivity: Associations with Age,Sexual Behavior,and Dating

Sexual self-perceptions are important aspects of sexuality, which can undergo significant change during adolescence and early adulthood. The purpose of this study was to describe these changes among girls (N = 251; ages 16–25) over one year, and to examine associations of sexual self-perceptions (sexual subjectivity) with age, sexual behavior, and romantic status. Sexual body-esteem, perceptions of entitlement to desire and pleasure, sexual efficacy, and sexual self-reflection were investigated as elements of sexual subjectivity. All sexual subjectivity elements were higher among girls who had more sexual experience and/or had steady romantic partners during the study. Perception of entitlement to desire and pleasure increased over time, whereas sexual body-esteem showed the most stability and had minimal associations with sexual or romantic experiences. The greatest increases in sexual subjectivity were found among girls who began the study with the least sociosexual experience and self-reflection also increased for girls who had first coitus after the start of the study. Overall, girls who had sexual intercourse the earliest (before age 16) had the highest sexual subjectivity, but sexual subjectivity increased the most among girls without coital experience or who had more recent first coitus.     

Positive Effects of “Textured Lunches” Gatherings and Oral Exercises Combined with Physical Exercises on Oral and Physical Function in Older Individuals: A Cluster Randomized Controlled Trial

Objectives

Proper nutrition and physical exercises are essential to prevent frailty in older adults. Proper masticatory performance and oral function may influence on physical activities as well since the mouth is the entrance of nutrition and digestion. Thus, the present study aimed to test the combined program of specially devised lunch gatherings containing textured foods with oral and physical exercises on the improvement of oral and physical function in community-dwelling older adults.

Design

A Cluster randomized controlled trial

Setting and Participants

Eighty-six community-dwelling older adults in Daito city, Japan, were randomly assigned into control (n = 43) or intervention (n = 43) groups.

Intervention

The control group performed the physical exercise regimen only. The intervention group participated in a 12-week physical and oral exercise program and ate a so-called “munchy lunch” that introduced textured foods with proper nutrients together after performing the physical exercise twice a week following brief dietary instruction at the intervention onset. Physical training and lunch gatherings were held at local public centers.

Measurements

The differences in measured variables for physical and oral function between baseline and 12 weeks of intervention were statistically tested. Results: Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group. Physical properties and activities, including body fat percentage and results of the timed up and go test, decreased more significantly in the intervention group than in controls (p<0.05).

Conclusions

Our findings suggest that a combined program of textured lunch gatherings with oral and physical exercises may improve physical and oral function as a preventative approach for frailty in community-dwelling older adults.