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Background Probiotics may alleviate lactose maldigestion. Objectives The objective was to select a probiotic with high lactase activity and compare it with lactase and placebo in clinical trials. Methods Bacterial cultures were screened for lactase activity in a model of the upper gastrointestinal (GI) tract. Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) counts were adjusted in subsequent experiments to correspond to 4500 Food Chemicals Codex (FCC) units of lactase, the amount in the European Food Safety Authority (EFSA)-approved health claim. Two crossover clinical trials, Booster Alpha and Booster Omega, were performed in participants with lactose intolerance, where 2 × 1012 CFUs Bi-07, 4662 FCC lactase, or placebo was consumed simultaneously with a lactose challenge, with 1-wk washouts between challenges. The trial designs were identical except for the source of lactose. Breath hydrogen concentration (BHC) was measured to assess the effect of the investigational products on lactose digestion, for which incremental area under the curve (iAUC) was the primary outcome. Peak BHC, cumulative BHC, and GI symptoms were secondary outcomes. Results Bi-07 was superior to placebo in reducing BHC [iAUC, parts per million (ppm) ∙ h] in both trials (Booster Alpha: geometric least square mean ratio: 0.462; 95% CI: 0.249, 0.859; P =  0.016; Booster Omega: 0.227; 95% CI: 0.095, 0.543; P  = 0.001). Lactase was superior to placebo in Booster Alpha (0.190; 95% CI: 0.102, 0.365; P  < 0.001) but not Booster Omega (0.493; 95% CI: 0.210, 1.156; P  = 0.102). Noninferiority of Bi-07 compared with lactase was observed in Booster Omega (0.460; 95% CI: 0.193, 1.096; P  = 0.079; CI upper limit < 1.25 noninferiority margin). Odds of abdominal pain (compared with placebo: 0.32, P  = 0.036) and flatulence (compared with placebo: 0.25, P  = 0.007) were lower with lactase in Booster Alpha. Increased odds of nausea were seen with Bi-07 (compared with placebo: 4.0, P  = 0.005) in Booster Omega. Conclusions Bi-07 has high lactase activit y , and in 2 clinical trials, it supported lactose digestion in individuals with lactose intolerance. These trials were registered at clinicaltrials.gov as NCT03659747 (Booster Alpha) and NCT03814668 (Booster Omega). [ABSTRACT FROM AUTHOR]

Background: The use of guideline-directed medical therapy (GDMT) is underprescribed in patients with heart failure with reduced ejection fraction (HFrEF).Objectives: This study sought to examine whether targeted and tailored electronic health record (EHR) alerts recommending GDMT in eligible patients with HFrEF improves GDMT use.Methods: PROMPT-HF (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure) was a pragmatic, EHR-based, cluster-randomized comparative effectiveness trial. A total of 100 providers caring for patients with HFrEF were randomized to either an alert or usual care. The alert notified providers of individualized GDMT recommendations along with patient characteristics. The primary outcome was an increase in the number of GDMT classes prescribed at 30 days postrandomization. Providers were surveyed on knowledge of guidelines and user experience.Results: The study enrolled 1,310 ambulatory patients with HFrEF from April to October 2021. Median age was 72 years; 31% were female; 18% were Black; and median left ventricular ejection fraction was 32%. At baseline, 84% of participants were receiving β-blockers, 71% received a renin-angiotensin-aldosterone system inhibitor, 29% received a mineralocorticoid receptor antagonist, and 11% received a sodium-glucose cotransporter-2 inhibitor. The primary outcome occurred in 176 of 685 (26%) participants in the alert arm vs 117 of 625 (19%) in the usual care arm, thus increasing GDMT class prescription by >40% after alert exposure (adjusted relative risk: 1.41; 95% CI: 1.03-1.93; P = 0.03). The number of patients needed to alert to result in an increase in addition of GDMT classes was 14. A total of 79% of alerted providers agreed that the alert was effective at enabling improved prescription of medical therapy for HF.Conclusions: A real-time, targeted, and tailored EHR-based alerting system for outpatients with HFrEF led to significantly higher rates of GDMT at 30 days when compared with usual care. This low-cost intervention can be rapidly integrated into clinical care and accelerate adoption of high-value therapies in heart failure. (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure [PROMPT-HF; NCT04514458]). [ABSTRACT FROM AUTHOR]

Background The obesogenic environment of Western countries raises questions about its current management. Some clinical studies have explored hypnosis, although the current state of knowledge does not lead to definitive conclusions about its efficacy. Objectives We assessed the impact of Ericksonian hypnosis and self-hypnosis on disinhibition of eating in adults with obesity and high food impulsivity levels, compared with standard nutritional education. Methods From September 2014 to July 2015, adults with BMI (in kg/m2) of 30–40 and a high disinhibition score [>8 on the Three Factor Eating Questionnaire (TFEQ-51)] were included in a randomized controlled trial. The control and hypnosis groups received the same standard nutrition education in 8 workshops. In the hypnosis group, subjects had 8 sessions of hypnosis combined with training in self-hypnosis. Disinhibition (primary outcome) and other scores from the TFEQ-51 as well as anthropometric, food intake, cardiometabolic, and physical activity variables were collected at inclusion and at 8 mo. Results Of 82 randomly assigned adults, 70 participated in all sessions; 80 participated in ≥1 session and were included in the main analysis (hypnosis group, n  = 41; control group, n  = 39). After 8 mo of follow-up, disinhibition scores adjusted for baseline values were lower in the hypnosis group, with a mean between-group difference of 4.2 (95% CI: 2.8, 5.5; P  < 0.001); 67.7% of adults in the hypnosis group had normalized their disinhibition (compared with 11.1% in control; P  < 0.0001). Differences for weight (1.8 kg; 95% CI: −0.1, 3.7 kg; P  = 0.052), BMI (0.8; 95% CI: 0.1, 1.4; P  = 0.028), susceptibility to hunger score (2.2; 95% CI: 1.0, 3.3; P  < 0.001), and its 2 subscales also favored the hypnosis group. Conclusions In the management of adults with obesity and a high disinhibition score, hypnosis and self-hypnosis can significantly improve the deep mechanisms of eating behaviors and seem to have a beneficial effect on weight loss. This trial was registered at clinicaltrials.gov as NCT02292108. [ABSTRACT FROM AUTHOR]

Background: Nonalcoholic fatty liver disease (NAFLD) is frequent among patients undergoing bariatric surgery. Beyond weight reduction, dietary supplements like micronutrients or probiotics that modify insulin resistance and lipotoxicity can be used to prevent or delay the progression of liver disease.Objectives: We evaluated the effect of a dietary approach with a specifically tailored multistrain probiotic and micronutrient mixture compared with a basic care micronutrient supplement on serum alanine aminotransferase (ALAT) in obese patients after mini gastric bypass (MGB) surgery.Methods: This randomized, double-blind, controlled trial included 60 obese patients (age: 40 ± 10 y; BMI: 44 ± 3 kg/m²). Patients received a combination of specifically tailored multistrain probiotic powder and a specific micronutrient mixture (Pro+SM) or a control treatment consisting of a placebo and a basic care micronutrient mixture (Con+BM), with some micronutrients in lower doses than SM, for 12 wk after hospital discharge. Primary (serum ALAT) and secondary outcomes [serum aspartate aminotransferase (ASAT), fatty liver index, NAFLD fibrosis score, glucose metabolism, blood pressure (BP), heart rate] were assessed at week 0 and week 12. Data were analyzed using unpaired Student's t-tests or Mann-Whitney U tests to compare the changes due to each treatment to one another.Results: A total of 48 patients were included in the analyses. Changes in serum ALAT concentrations did not differ between groups. Compared with Con+BM, Pro+SM improved serum ASAT (difference: -8.0 U/L, 95% CI: -17.0, -4.0; P = 0.043), NAFLD fibrosis score (difference: -0.39; 95% CI: -0.78, 0; P = 0.048), serum triglycerides (difference: -22.8 mg/dL; 95% CI: -45.6, -0.1; P = 0.049) and the visceral adiposity index (difference: -0.70; 95% CI: -1.31, -0.08; P = 0.027).Conclusion: Supplementation with a specifically tailored probiotic and micronutrient mixture improved NAFLD-related markers more than a basic micronutrient mixture in obese patients following MGB surgery. The trial was registered under clinicaltrials.gov as NCT03585413. [ABSTRACT FROM AUTHOR]

Background: The glycemic effects of peanuts are not well studied and no trials have been conducted in adults with elevated fasting plasma glucose (FPG). Furthermore, intake of peanuts as a nighttime snack, an eating occasion affecting FPG, has not been examined.Objectives: The aim was to determine the effect of consuming 28 g/d of peanuts as a nighttime snack for 6 wk on glycemic control and cardiovascular disease risk factors, compared with an isocaloric lower fat, higher carbohydrate (LFHC) snack (whole grain crackers and low-fat cheese), in adults with elevated FPG.Methods: In a randomized crossover trial, 50 adults (FPG 100 ± 8 mg/dL) consumed dry roasted, unsalted peanuts [164 kcal; 11% energy (E) carbohydrate, 17% E protein, and 73% E fat] or a LFHC snack (164 kcal; 54% E carbohydrate, 17% E protein, and 33% E fat) in the evening (after dinner and before bedtime) for 6 wk with a 4-wk washout period. Primary (FPG) and secondary end points [Healthy Eating Index-2015 (HEI-2015), weight, insulin, fructosamine, lipids/lipoproteins, central and peripheral blood pressure, and pulse wave velocity] were evaluated at the beginning and end of each condition. Linear mixed models were used for data analysis.Results: FPG was not different between the peanut and LFHC conditions (end point mean difference: -0.6 mg/dL; 95% CI: -2.7, 1.6; P = 0.67). There were no between-condition effects for secondary cardiometabolic endpoints. The HEI-2015 score was not different between the conditions (3.6 points; P = 0.19), although the seafood/plant protein (2.0 points; P < 0.01) and added sugar (0.8 points; P = 0.04) components were improved following peanut intake. The whole grain component was lower with peanuts compared with LFHC (-2.6 points; P < 0.01).Conclusions: In adults with elevated FPG, peanuts as a nighttime snack (28 g/d) did not affect FPG compared with an isocaloric LFHC snack after 6 wk.This trial was registered at clinicaltrials.gov as NCT03654651. [ABSTRACT FROM AUTHOR]

Background A large proportion of infants in low- and middle-income countries are stunted. These infants are often fed complementary foods that are low-quality, primarily in terms of protein and micronutrients. Objectives We aimed to test 2 milk–cereal mixes supplemented with modest and high amounts of protein during 6–12 mo of age, compared with no supplementation, for their effect on length-for-age z score (LAZ) at 12 mo of age. Methods Eligible infants (6 mo plus ≤29 d) were randomly assigned to either of the 2 interventions (modest- and high-protein) or a no supplement group. The milk–cereal mixes provided ∼125 kcal, 30%–45% energy from fats, and 80%–100% RDA of multiple micronutrients (MMN). The modest-protein group received 2.5 g protein [protein energy ratio (PER): 8%; 0.75 g from milk source] and the high-protein group received 5.6 g protein (PER: 18%, 1.68 g from milk source). One packet was given daily for 180 d. Counseling on continued breastfeeding and optimal infant-care practices was provided to all. Results We enrolled 1548 infants (high-protein: n  = 512; modest-protein: n  = 519; and no supplement: n  = 517). Compared with the no supplement group, there was an improvement in LAZ [adjusted mean difference (MD): 0.08; 95% CI: 0.01, 0.15], weight-for-age z score (MD: 0.12; 95% CI: 0.06, 0.19), weight-for-length z score (MD: 0.11; 95% CI: 0.02, 0.19), and midupper arm circumference z score (MD: 0.10; 95% CI: 0.02, 0.18) in the high-protein group at 12 mo of age. No significant differences for these anthropometric indicators were noted between the modest-protein and no supplement groups or between the high- and modest-protein groups. Conclusions Cereal mixes with higher amounts of milk-based protein and MMN may lead to improvement in linear growth and other anthropometric indexes in infants, compared with no supplementation. This trial was registered at ctri.nic.in as CTRI/2018/04/012932. [ABSTRACT FROM AUTHOR]

• There is a lack of information about the effectiveness of foot-ankle muscle strengthening program on pain and functioning in people with KOA. • An 8-week foot-ankle muscle strengthening program decreased knee pain and enhanced physical function in individuals with KOA, presenting a potential to be clinically meaningful. • Foot-ankle muscle strengthening program can be a treatment option for individuals with knee osteoarthritis (KOA) who do not tolerate exercises with excessive load on the knee. Foot-ankle exercises could improve pain and function of individuals with KOA and need to be tested. To investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function. In this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences. The intervention group showed lower pain scores (−4.4 units; 95%CI = −7.5, −1.1), better function (−7.1 units; 95%CI = −12.7, −1.4), higher total functional score (−11.9 units; 95%CI = −20.7, −3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95%CI = 1.1, 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls. The 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care. NCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059 [ABSTRACT FROM AUTHOR]