A Ketogenic Diet Is Acceptable in Women with Ovarian and Endometrial Cancer and Has No Adverse Effects on Blood Lipids: A Randomized,Controlled Trial

Abstract

Ketogenic diets (KDs) are emerging as effective therapies for several chronic diseases, including cancer. However, concerns regarding safety and adherence may prevent clinicians from prescribing KDs. We hypothesized that a KD does not negatively affect blood lipid profile compared to a lower-fat diet in ovarian and endometrial cancer patients, and that KD subjects would demonstrate acceptable adherence. Subjects were randomized to either a KD (70% fat, 25% protein, 5% carbohydrate), or the American Cancer Society diet (ACS; high-fiber and lower-fat). Blood lipids and ketones were measured at baseline and after 12?weeks of the assigned intervention. Adherence measures included urinary ketones in the KD and 4 days’ diet records. Diet records were also examined to identify general patterns of consumption. Differences between the diets on blood lipids and dietary intake were assessed with Analysis of covariance and independent t-tests. Correlation analyses were used to estimate associations between dietary intake and serum analytes. At 12?weeks, there were no significant differences between diet groups in blood lipids, after adjusting for baseline values and weight loss. Adherence among KD subjects ranged from 57% to 80%. These findings suggest that KDs may be a safe and achievable component of treatment for some cancer patients.     

Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial

Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and the acceptability of the intervention in preparation for an 8-week RCT in the future, which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed (n = 10) and non-depressed (n = 6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to their diet allocation and the study hypotheses. Health questionnaires were completed before and after the intervention and, throughout the study, questionnaires assessed participants’ liking for the meals, their sensory properties, adherence, and open-ended feedback. In the ND group, 75% of participants consumed only the provided foods, as instructed, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.     

A Ketogenic Low-Carbohydrate High-Fat Diet Increases LDL Cholesterol in Healthy,Young, Normal-Weight Women: A Randomized Controlled Feeding Trial

Ketogenic low-carbohydrate high-fat (LCHF) diets are popular among young, healthy, normal-weight individuals for various reasons. We aimed to investigate the effect of a ketogenic LCHF diet on low-density lipoprotein (LDL) cholesterol (primary outcome), LDL cholesterol subfractions and conventional cardiovascular risk factors in the blood of healthy, young, and normal-weight women. The study was a randomized, controlled, feeding trial with crossover design. Twenty-four women were assigned to a 4 week ketogenic LCHF diet (4% carbohydrates; 77% fat; 19% protein) followed by a 4 week National Food Agency recommended control diet (44% carbohydrates; 33% fat; 19% protein), or the reverse sequence due to the crossover design. Treatment periods were separated by a 15 week washout period. Seventeen women completed the study and treatment effects were evaluated using mixed models. The LCHF diet increased LDL cholesterol in every woman with a treatment effect of 1.82 mM (p < 0.001). In addition, Apolipoprotein B-100 (ApoB), small, dense LDL cholesterol as well as large, buoyant LDL cholesterol increased (p < 0.001, p < 0.01, and p < 0.001, respectively). The data suggest that feeding healthy, young, normal-weight women a ketogenic LCHF diet induces a deleterious blood lipid profile. The elevated LDL cholesterol should be a cause for concern in young, healthy, normal-weight women following this kind of LCHF diet.     

Efficacy of Low-Carbohydrate Ketogenic Diet as an Adjuvant Cancer Therapy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Background: The role of low-carbohydrate ketogenic diet (LCKD) as an adjuvant therapy in antitumor treatment is not well established. This systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to investigate the efficacy of LCKD as an adjuvant therapy in antitumor treatment compared to non-ketogenic diet in terms of lipid profile, body weight, fasting glucose level, insulin, and adverse effects; Methods: In this study, databases such as PubMed, Web of Science, Scopus, CINAHL, and Cochrane trials were searched. Only RCTs that involved cancer participants that were assigned to dietary interventions including a LCKD group and a control group (any non-ketogenic dietary intervention) were selected. Three reviewers independently extracted the data, and the meta-analysis was performed using a fixed effects model or random effects model depending on the I² value or p-value; Results: A total of six articles met the inclusion/exclusion criteria. In the overall analysis, the post-intervention results = standard mean difference, SMD (95% CI) showed total cholesterol (TC) level = 0.25 (−0.17, 0.67), HDL-cholesterol = −0.07 (−0.50, 0.35), LDL-cholesterol = 0.21 (−0.21, 0.63), triglyceride (TG) = 0.09 (−0.33, 0.51), body weight (BW) = −0.34 (−1.33, 0.65), fasting blood glucose (FBG) = −0.40 (−1.23, 0.42) and insulin = 0.11 (−1.33, 1.55). There were three outcomes showing significant results in those in LCKD group: the tumor marker PSA, p = 0.03, the achievement of ketosis p = 0.010, and the level of satisfaction, p = 0.005; Conclusions: There was inadequate evidence to support the beneficial effects of LCKDs on antitumor therapy. More trials comparing LCKD and non-KD with a larger sample size are necessary to give a more conclusive result.     

Delivering Preventive Health Services for Breast Cancer Control: A Longitudinal View of a Randomized Controlled Trial

Objective. To develop a longitudinal model to characterize the delivery of mammography services using repeated observations of mammography referral rates during a randomized controlled trial (RCT) of physician mammography reminders. Data Sources/Study Setting . Administrative records of a health department and observational data on mammography appointment scheduling. Study Design. The design was a longitudinal study of month‐specific referral rates during a 1‐year RCT. A retrospective case‐control study was used to investigate differences between women with timely and delayed (or absent) mammography referral assessed at the end of the intervention year. Data Collection/Extraction Methods. Month‐specific indicators for referrals and missed clinical opportunities, that is, months when clinic visitors were due for a mammogram and not referred, were constructed using administrative and observational data. Findings. In the unadjusted analysis, the effectiveness of the reminder declined over time. However, in a multivariate analysis that controlled for the number of missed opportunities, the effectiveness was constant over time. On a monthly basis, physician reminders were significantly associated with higher referral rates among clinic visitors newly due for mammography (adjusted OR=2.8, 95 percent CI=1.3, 5.8) or who had one previously missed clinical opportunity (adjusted OR=3.0, 95 percent CI=1.6, 5.3) but were not for those with two or more missed clinical opportunities (adjusted OR=1.2, 95 percent CI=0.7, 2.3). Factors independently associated with delayed referral were age over 65, presence of more than one chronic illness, and the absence of a physician mammography reminder. Conclusions. Longitudinal models that examine rates of referral over time and include information about outcomes on previous visits can enhance our understanding of how intervention strategies work in practice.     

Ketogenic Effects of Multiple Doses of a Medium Chain Triglycerides Enriched Ketogenic Formula in Healthy Men under the Ketogenic Diet: A Randomized,Double-Blinded,Placebo-Controlled Study

Ketogenic diets, which are carbohydrate-restricted high-fat diets, may have therapeutic effects on various diseases, including cancer. However, ketogenic diets are often not standardized and, therefore, results are difficult to interpret. We previously investigated the usefulness of ketogenic diets in cancer therapy, where ketogenic formulas (KF) were used as supplements to enhance blood ketone bodies; however, the amount of KF was determined empirically with reference to blood ketone bodies levels. Here, to determine a standardized optimal amount of KF, we investigated temporal changes in blood ketone bodies (acetoacetic acid (AcAc), β-hydroxybutyrate (BHB)) and safety in 20 healthy individuals when KF was taken repeatedly under the conditions of a ketogenic diet (UMIN000034216). The diurnal variation in total ketone bodies, and AcAc and BHB levels significantly increased after lunch and after dinner, on the 4th day of KF administration. There were no significant safety issues related to KF in the context of anthropometric, metabolic, nutritional, urological and gastrointestinal parameters. In addition, ketogenic diets lead to changes in gut microbiota. KF showed a decrease in phylum Firmicutes. Our study provides baseline data of the usefulness of KF in a ketogenic diet.     

Tolerability and Safety of a Novel Ketogenic Ester,Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults

Nutritional ketosis is a state of mildly elevated blood ketone concentrations resulting from dietary changes (e.g., fasting or reduced carbohydrate intake) or exogenous ketone consumption. In this study, we determined the tolerability and safety of a novel exogenous ketone diester, bis-hexanoyl-(R)-1,3-butanediol (BH-BD), in a 28-day, randomized, double-blind, placebo-controlled, parallel trial ({"type":"clinical-trial","attrs":{"text":"NCT04707989","term_id":"NCT04707989"}}NCT04707989). Healthy adults (n = 59, mean (SD), age: 42.8 (13.4) y, body mass index: 27.8 (3.9) kg/m²) were randomized to consume a beverage containing 12.5 g (Days 0–7) and 25 g (Days 7–28) of BH-BD or a taste-matched placebo daily with breakfast. Tolerability, stimulation, and sedation were assessed daily by standardized questionnaires, and blood and urine samples were collected at Days 0, 7, 14, and 28 for safety assessment. There were no differences in at-home composite systemic and gastrointestinal tolerability scores between BH-BD and placebo at any time in the study, or in acute tolerability measured 1-h post-consumption in-clinic. Weekly at-home composite tolerability scores did not change when BH-BD servings were doubled. At-home scores for stimulation and sedation did not differ between groups. BH-BD significantly increased blood ketone concentrations 1-h post-consumption. No clinically meaningful changes in safety measures including vital signs and clinical laboratory measurements were detected within or between groups. These results support the overall tolerability and safety of consumption of up to 25 g/day BH-BD.     

Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized,Double-Blind,Controlled Pilot Trial

Abstract

Background: This pilot, double-blind, comparator-controlled trial evaluated the safety and tolerability of an oral targeted medical nutrition (TMN) supplement for the management of cachexia in patients with non-small-cell lung cancer (NSCLC).

Methods: Patients receiving first-line chemotherapy for NSCLC with weight loss or low BMI were randomized 1:1 to receive juice-based TMN (～200?kcal; 10?g whey protein; ≥2.0?g eicosapentaenoic acid/docosahexaenoic acid in fish oil; and 10?μg 25-hydroxy-vitamin D3) or a milk-based isocaloric comparator twice daily for 12?weeks (ClinicalTrials.gov: NCT02515032). Primary endpoints included number/type of adverse events and changes in vital signs/laboratory parameters. Secondary endpoints included measures of clinical relevance. Survival was an exploratory endpoint.

Results: The TMN group (n?=?26; mean 64.4?years) experienced fewer adverse events (64 vs. 87) than the comparator group (n?=?29; mean 66.0?years), including fewer cases of neutropenia (0 vs. 4). Compliance was slightly lower in the TMN (58.5%) vs. comparator group (73.6%). There were no statistically significant between-group differences in efficacy endpoints. Fewer (4 vs. 10) patients who received TMN than comparator had died by 1-year post baseline.

Conclusions: TMN was well tolerated. Trends for improved clinical outcomes with TMN identified in this study warrant further investigation.     

Prehabilitation for Bariatric Surgery: A Randomized,Controlled Trial Protocol and Pilot Study

Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.     

The Effects of a Low-Carbohydrate Diet vs. a Low-Fat Diet on Novel Cardiovascular Risk Factors: A Randomized Controlled Trial

Increasing evidence supports a low-carbohydrate diet for weight loss and improvement in traditional cardiovascular disease (CVD) markers. Effects on novel CVD markers remain unclear. We examined the effects of a low-carbohydrate diet (<40 g/day; n = 75) versus a low-fat diet (<30% kcal/day from total fat, <7% saturated fat; n = 73) on biomarkers representing inflammation, adipocyte dysfunction, and endothelial dysfunction in a 12 month clinical trial among 148 obese adults free of diabetes and CVD. Participants met with a study dietitian on a periodic basis and each diet group received the same behavioral curriculum which included dietary instruction and supportive counseling. Eighty percent of participants completed the intervention. At 12 months, participants on the low-carbohydrate diet had significantly greater increases in adiponectin (mean difference in change, 1336 ng/mL (95% CI, 342 to 2330 ng/mL); p = 0.009) and greater decreases in intercellular adhesion molecule-1 concentrations (−16.8 ng/mL (−32.0 to −1.6 ng/mL); p = 0.031) than those on the low-fat diet. Changes in other novel CVD markers were not significantly different between groups. In conclusion, despite the differences in weight changes on diets, a low-carbohydrate diet resulted in similar or greater improvement in inflammation, adipocyte dysfunction, and endothelial dysfunction than a standard low-fat diet among obese persons.     

Ketogenic Diet for Cancer: Critical Assessment and Research Recommendations

Despite remarkable improvements in screening, diagnosis, and targeted therapies, cancer remains the second leading cause of death in the United States. It is increasingly clear that diet and lifestyle practices play a substantial role in cancer development and progression. As such, various dietary compositions have been proposed for reducing cancer risk and as potential adjuvant therapies. In this article, we critically assess the preclinical and human trials on the effects of the ketogenic diet (KD, i.e., high-fat, moderate-to-low protein, and very-low carbohydrate content) for cancer-related outcomes. The mechanisms underlying the hypothesized effects of KD, most notably the Warburg Effect, suggest that restricting carbohydrate content may impede cancer development and progression via several pathways (e.g., tumor metabolism, gene expression). Overall, although preclinical studies suggest that KD has antitumor effects, prolongs survival, and prevents cancer development, human clinical trials are equivocal. Because of the lack of high-quality clinical trials, the effects of KD on cancer and as an adjunctive therapy are essentially unknown. We propose a set of research recommendations for clinical studies examining the effects of KD on cancer development and progression.     

Effect of a Remotely Delivered Weight Loss Intervention in Early-Stage Breast Cancer: Randomized Controlled Trial

Limited evidence exists on the effects of weight loss on chronic disease risk and patient-reported outcomes in breast cancer survivors. Breast cancer survivors (stage I–III; body mass index 25–45 kg/m²) were randomized to a 12-month, remotely delivered (22 telephone calls, mailed material, optional text messages) weight loss (diet and physical activity) intervention (n = 79) or usual care (n = 80). Weight loss (primary outcome), body composition, metabolic syndrome risk score and components, quality of life, fatigue, musculoskeletal pain, menopausal symptoms, fear of recurrence, and body image were assessed at baseline, 6 months, 12 months (primary endpoint), and 18 months. Participants were 55 ± 9 years and 10.7 ± 5.0 months post-diagnosis; retention was 81.8% (12 months) and 80.5% (18 months). At 12-months, intervention participants had significantly greater improvements in weight (−4.5% [95%CI: −6.5, −2.5]; p < 0.001), fat mass (−3.3 kg [−4.8, −1.9]; p < 0.001), metabolic syndrome risk score (−0.19 [−0.32, −0.05]; p = 0.006), waist circumference (−3.2 cm [−5.5, −0.9]; p = 0.007), fasting plasma glucose (−0.23 mmol/L [−0.44, −0.02]; p = 0.032), physical quality of life (2.7 [0.7, 4.6]; p = 0.007; Cohen’s effect size (d) = 0.40), musculoskeletal pain (−0.5 [−0.8, −0.2]; p = 0.003; d = 0.49), and body image (−0.2 [−0.4, −0.0]; p = 0.030; d = 0.31) than usual care. At 18 months, effects on weight, adiposity, and metabolic syndrome risk scores were sustained; however, significant reductions in lean mass were observed (−1.1 kg [−1.7, −0.4]; p < 0.001). This intervention led to sustained improvements in adiposity and metabolic syndrome risk.     

The Specific Carbohydrate Diet and Diet Modification as Induction Therapy for Pediatric Crohn’s Disease: A Randomized Diet Controlled Trial

Background: Crohn’s disease (CD) is a chronic inflammatory intestinal disorder associated with intestinal dysbiosis. Diet modulates the intestinal microbiome and therefore has a therapeutic potential. The aim of this study is to determine the potential efficacy of three versions of the specific carbohydrate diet (SCD) in active Crohn’s Disease. Methods: 18 patients with mild/moderate CD (PCDAI 15–45) aged 7 to 18 years were enrolled. Patients were randomized to either SCD, modified SCD(MSCD) or whole foods (WF) diet. Patients were evaluated at baseline, 2, 4, 8 and 12 weeks. PCDAI, inflammatory labs and multi-omics evaluations were assessed. Results: Mean age was 14.3 ± 2.9 years. At week 12, all participants (n = 10) who completed the study achieved clinical remission. The C-reactive protein decreased from 1.3 ± 0.7 at enrollment to 0.9 ± 0.5 at 12 weeks in the SCD group. In the MSCD group, the CRP decreased from 1.6 ± 1.1 at enrollment to 0.7 ± 0.1 at 12 weeks. In the WF group, the CRP decreased from 3.9 ± 4.3 at enrollment to 1.6 ± 1.3 at 12 weeks. In addition, the microbiome composition shifted in all patients across the study period. While the nature of the changes was largely patient specific, the predicted metabolic mode of the organisms increasing and decreasing in activity was consistent across patients. Conclusions: This study emphasizes the impact of diet in CD. Each diet had a positive effect on symptoms and inflammatory burden; the more exclusionary diets were associated with a better resolution of inflammation.     

Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review

The ketogenic diet (KD) is a restrictive therapeutic diet, distinguished by being hyperlipidic, normoproteic, and hypoglucidic. This diet simulates biochemical changes related to fasting periods to achieve systemic ketosis. The metabolic particularities of glioma tumors motivated the rise in investigations and nutritional strategies, such as KD, to modulate the glycemic response as a treatment. This systematic review followed the PRISMA recommendations and was published in PROSPERO, with the identification CRD42021264173. The databases used were EMBASE, PubMed/Medline, Scopus, and Web of Science, and the studies were analyzed using the web-based application Rayyan. To analyze the risk of bias, Cochrane RevMan 5 software was used. For the analysis and treatment of statistical data, Microsoft® Excel® was used. A total of nine original articles were included. Data on survival, symptomology, and quality of life were collected. Mean overall survival was 15.9 months. Constipation and fatigue were the most reported symptoms. In 44.4% of the studies, an improvement in the quality of life was found. The KD is supported by most published studies as an effective therapy in the treatment of malignant gliomas due to its positive effects on patient survival. It was not possible to conclude the effectiveness of KD on quality of life.     

A Nutritional Perspective of Ketogenic Diet in Cancer: A Narrative Review

The predominant use of glucose anaerobically by cancer cells (Warburg effect) may be the most important characteristic the majority of these cells have in common and, therefore, a potential metabolic pathway to be targeted during cancer treatment. Because this effect relates to fuel oxidation, dietary manipulation has been hypothesized as an important strategy during cancer treatment. As such, the concept of a ketogenic diet (KD) in cancer emerged as a metabolic therapy (ie, targeting cancer cell metabolism) rather than a dietary approach. The therapeutic mechanisms of action of this high-fat, moderate-to-low protein, and very-low-carbohydrate diet may potentially influence cancer treatment and prognosis. Considering the lack of a dietetics-focused narrative review on this topic, we compiled the evidence related to the use of this diet in humans with diverse cancer types and stages, also focusing on the nutrition and health perspective. The use of KD in cancer shows potentially promising, but inconsistent, results. The limited number of studies and differences in study design and characteristics contribute to overall poor quality evidence, limiting the ability to draw evidence-based conclusions. However, the potential positive influences a KD may have on cancer treatment justify the need for well-designed clinical trials to better elucidate the mechanisms by which this dietary approach affects nutritional status, cancer prognosis, and overall health. The role of registered dietitian nutritionists is demonstrated to be crucial in planning and implementing KD protocols in oncology research settings, while also ensuring patients’ adherence and optimal nutritional status.     

Sociopsychological Tailoring to Address Colorectal Cancer Screening Disparities: A Randomized Controlled Trial

PURPOSE

Interventions tailored to sociopsychological factors associated with health behaviors have promise for reducing colorectal cancer screening disparities, but limited research has assessed their impact in multiethnic populations. We examined whether an interactive multimedia computer program (IMCP) tailored to expanded health belief model sociopsychological factors could promote colorectal cancer screening in a multiethnic sample.

METHODS

We undertook a randomized controlled trial, comparing an IMCP tailored to colorectal cancer screening self-efficacy, knowledge, barriers, readiness, test preference, and experiences with a nontailored informational program, both delivered before office visits. The primary outcome was record-documented colorectal cancer screening during a 12-month follow-up period. Secondary outcomes included postvisit sociopsychological factor status and discussion, as well as clinician recommendation of screening during office visits. We enrolled 1,164 patients stratified by ethnicity and language (49.3% non-Hispanic, 27.2% Hispanic/English, 23.4% Hispanic/Spanish) from 26 offices around 5 centers (Sacramento, California; Rochester and the Bronx, New York; Denver, Colorado; and San Antonio, Texas).

RESULTS

Adjusting for ethnicity/language, study center, and the previsit value of the dependent variable, compared with control patients, the IMCP led to significantly greater colorectal cancer screening knowledge, self-efficacy, readiness, test preference specificity, discussion, and recommendation. During the followup period, 132 (23%) IMCP and 123 (22%) control patients received screening (adjusted difference = 0.5 percentage points, 95% CI −4.3 to 5.3). IMCP effects did not differ significantly by ethnicity/language.

CONCLUSIONS

Sociopsychological factor tailoring was no more effective than nontailored information in encouraging colorectal cancer screening in a multiethnic sample, despite enhancing sociopsychological factors and visit behaviors associated with screening. The utility of sociopsychological tailoring in addressing screening disparities remains uncertain.     

The Psychosocial Effects of a Companion Robot: A Randomized Controlled Trial

ObjectivesTo investigate the psychosocial effects of the companion robot, Paro, in a rest home/hospital setting in comparison to a control group.DesignRandomized controlled trial. Residents were randomized to the robot intervention group or a control group that attended normal activities instead of Paro sessions. Sessions took place twice a week for an hour over 12 weeks. Over the trial period, observations were conducted of residents’ social behavior when interacting as a group with the robot. As a comparison, observations were also conducted of all the residents during general activities when the resident dog was or was not present.SettingA residential care facility in Auckland, New Zealand.ParticipantsForty residents in hospital and rest home care.MeasurementsResidents completed a baseline measure assessing cognitive status, loneliness, depression, and quality of life. At follow-up, residents completed a questionnaire assessing loneliness, depression, and quality of life. During observations, behavior was noted and collated for instances of talking and stroking the dog/robot.ResultsIn comparison with the control group, residents who interacted with the robot had significant decreases in loneliness over the period of the trial. Both the resident dog and the seal robot made an impact on the social environment in comparison to when neither was present. Residents talked to and touched the robot significantly more than the resident dog. A greater number of residents were involved in discussion about the robot in comparison with the resident dog and conversation about the robot occurred more.ConclusionParo is a positive addition to this environment and has benefits for older people in nursing home care. Paro may be able to address some of the unmet needs of older people that a resident animal may not, particularly relating to loneliness.     

A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial

Postmenopausal breast cancer is the most common obesity-related cancer death among women in the U.S. Insulin resistance, which worsens in the setting of obesity, is associated with higher breast cancer incidence and mortality. Maladaptive eating patterns driving insulin resistance represent a key modifiable risk factor for breast cancer. Emerging evidence suggests that time-restricted feeding paradigms (TRF) improve cancer-related metabolic risk factors; however, more flexible approaches could be more feasible and effective. In this exploratory, secondary analysis, we identified participants following a low-glucose eating pattern (LGEP), defined as consuming energy when glucose levels are at or below average fasting levels, as an alternative to TRF. Results show that following an LGEP regimen for at least 40% of reported eating events improves insulin resistance (HOMA-IR) and other cancer-related serum biomarkers. The magnitude of serum biomarkers changes observed here has previously been shown to favorably modulate benign breast tissue in women with overweight and obesity who are at risk for postmenopausal breast cancer. By comparison, the observed effects of LGEP were similar to results from previously published TRF studies in similar populations. These preliminary findings support further testing of LGEP as an alternative to TRF and a postmenopausal breast cancer prevention strategy. However, results should be interpreted with caution, given the exploratory nature of analyses.