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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 (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.

Personalized nutrition may be more effective in changing lifestyle behaviors compared to population-based guidelines. This single-arm exploratory study evaluated the impact of a 10-week personalized systems nutrition (PSN) program on lifestyle behavior and health outcomes. Healthy men and women (n = 82) completed the trial. Individuals were grouped into seven diet types, for which phenotypic, genotypic and behavioral data were used to generate personalized recommendations. Behavior change guidance was also provided. The intervention reduced the intake of calories (−256.2 kcal; p < 0.0001), carbohydrates (−22.1 g; p < 0.0039), sugar (−13.0 g; p < 0.0001), total fat (−17.3 g; p < 0.0001), saturated fat (−5.9 g; p = 0.0003) and PUFA (−2.5 g; p = 0.0065). Additionally, BMI (−0.6 kg/m2; p < 0.0001), body fat (−1.2%; p = 0.0192) and hip circumference (−5.8 cm; p < 0.0001) were decreased after the intervention. In the subgroup with the lowest phenotypic flexibility, a measure of the body’s ability to adapt to environmental stressors, LDL (−0.44 mmol/L; p = 0.002) and total cholesterol (−0.49 mmol/L; p < 0.0001) were reduced after the intervention. This study shows that a PSN program in a workforce improves lifestyle habits and reduces body weight, BMI and other health-related outcomes. Health improvement was most pronounced in the compromised phenotypic flexibility subgroup, which indicates that a PSN program may be effective in targeting behavior change in health-compromised target groups.

Background Metabolic syndrome, a constellation of metabolic risk factors for type 2 diabetes and cardiovascular disease, is one of the fastest growing disease entities in the world. Weight loss is thought to be a key to improving all aspects of metabolic syndrome. Research studies have suggested benefits from diets rich in vegetables and fruits in helping individuals reach and achieve healthy weights. Objective To evaluate the effects of a ready to serve vegetable juice as part of a calorie-appropriate Dietary Approaches to Stop Hypertension (DASH) diet in an ethnically diverse population of people with Metabolic Syndrome on weight loss and their ability to meet vegetable intake recommendations, and on their clinical characteristics of metabolic syndrome (waist circumference, triglycerides, HDL, fasting blood glucose and blood pressure). A secondary goal was to examine the impact of the vegetable juice on associated parameters, including leptin, vascular adhesion markers, and markers of the oxidative defense system and of oxidative stress. Methods A prospective 12 week, 3 group (0, 8, or 16 fluid ounces of low sodium vegetable juice) parallel arm randomized controlled trial. Participants were requested to limit their calorie intake to 1600 kcals for women and 1800 kcals for men and were educated on the DASH diet. A total of 81 (22 men & 59 women) participants with Metabolic Syndrome were enrolled into the study. Dietary nutrient and vegetable intake, weight, height, leptin, metabolic syndrome clinical characteristics and related markers of endothelial and cardiovascular health were measured at baseline, 6-, and 12-weeks. Results There were significant group by time interactions when aggregating both groups consuming vegetable juice (8 or 16 fluid ounces daily). Those consuming juice lost more weight, consumed more Vitamin C, potassium, and dietary vegetables than individuals who were in the group that only received diet counseling (p < 0.05). Conclusion The incorporation of vegetable juice into the daily diet can be a simple and effective way to increase the number of daily vegetable servings. Data from this study also suggest the potential of using a low sodium vegetable juice in conjunction with a calorie restricted diet to aid in weight loss in overweight individuals with metabolic syndrome.

Background Recommendations for daily dietary vegetable intake were increased in the 2005 USDA Dietary Guidelines as consumption of a diet rich in vegetables has been associated with lower risk of certain chronic health disorders including cardiovascular disease. However, vegetable consumption in the United States has declined over the past decade; consequently, the gap between dietary recommendations and vegetable intake is widening. The primary aim of this study is to determine if drinking vegetable juice is a practical way to help meet daily dietary recommendations for vegetable intake consistent with the 2005 Dietary Guidelines and the Dietary Approaches to Stop Hypertension (DASH) diet. The secondary aim is to assess the effect of a vegetable juice on measures of cardiovascular health. Methods We conducted a 12-week, randomized, controlled, parallel-arm study consisting of 3 groups of free-living, healthy volunteers who participated in study visits at the Ragle Human Nutrition Research Center at the University of California, Davis. All subjects received education on the DASH diet and 0, 8 or 16 fluid ounces of vegetable juice daily. Assessments were completed of daily vegetable servings before and after incorporation of vegetable juice and cardiovascular health parameters including blood pressure. Results Without the juice, vegetable intake in all groups was lower than the 2005 Dietary Guidelines and DASH diet recommendations. The consumption of the vegetable juice helped participants reach recommended intake. In general, parameters associated with cardiovascular health did not change over time. However, in the vegetable juice intervention groups, subjects who were pre-hypertensive at the start of the study showed a significant decrease in blood pressure during the 12-week intervention period. Conclusion Including 1-2 cups of vegetable juice daily was an effective and acceptable way for healthy adults to close the dietary vegetable gap. Increase in daily vegetable intake was associated with a reduction in blood pressure in subjects who were pre-hypertensive at the start of the trial. Trial Registration Clinicaltrials.gov NCT01161706

Ecological comparison of the incidence of cancer (eg, large-scale differences between countries in the incidence of breast, prostate, and colon cancer) can be explained best by substantial differences in the intake of dietary fat. Additionally, there is a vast amount of animal and mechanistic data that strongly supports the hypothesis that dietary fat, independent of caloric intake, appears to have a major effect on the incidence and mortality rates for cancer. Yet, results from human case and cohort studies are inconsistent in linking carcinogenesis with fat intake. This is due to several factors. Reported intakes may not reflect previous long-term intakes and may be con-founded by several sources of error, including memory and estimates of portion size. Additionally, ongoing media reports of adverse health effects from high-fat diets may impart a social desirability bias to self-reporting of fat intake. These factors may be significant when investigating the relationship between dietary intake and cancer. Studies have shown considerable error in self-reported dietary data, with under-estimations in energy intake ranging from 3% to 18%. Such a wide range likely is due to differences in dietary assessment methodologies, which highlights the need to continue to develop improved techniques of data collection to relate nutrition better to health outcomes. The Women's Intervention Nutrition Study (WINS) is investigating the effect, of dietary fat on the incidence of recurrence and survival in women with early-stage breast cancer. WINS is employing the multiple-pass 24-hour telephone recall system along with enhanced quality control measures to assess dietary intake. This dietary assessment method is particularly applicable when comparing two populations when one population is treated by an extensive dietary intervention. J Am Diet Assoc. 1997; 97(supll):S5-S8.

Over the years, the Supreme Court has developed a 2-pronged test for personal jurisdiction based on due process. This traditional test allows a court to exercise personal jurisdiction over a party that has not waived jurisdictional challenge when the court has power over the party and trial in that court would comport with fair play and substantial justice. To meet this test, the party, if not present in that forum, must have minimum contacts with that jurisdiction. Some commentators have argued that this traditional model is inapplicable to class actions - that in class action suits, courts can bind contactless and unconsenting class members. This ''weak model'' requires only satisfaction of the procedural due process requirements of fair notice and adequate representation to bind class members. The best approach is to apply the traditional model of jurisdiction to unnamed plaintiff class members in multistate class actions.