The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery - study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial.

BACKGROUND: Subjects with obesity exhibit changes in gut microbiota composition and function (i.e. dysbiosis) that contribute to metabolic dysfunction, including appetite impairment. Although bariatric surgery is an effective treatment for obesity with a great impact on weight loss, some subjects show weight regain due to increased energy intake after the surgery. This surgery involves gut microbiota changes that promote appetite control, but it seems insufficient to completely restore the obesity-associated dysbiosis - a possible contributor for weight regain. Thus, modulating gut microbiota with probiotics that could improve appetite regulation as a complementary approach to post-operative diet (i.e. Hafnia alvei HA4597™), may accentuate post-surgery weight loss and insulin sensitivity. METHODS: This is a protocol of a triple-blinded, blocked-randomized, parallel-group, placebo-controlled clinical trial designed to determine the effect of Hafnia alvei HA4597™ supplementation on weight loss and glycaemic control 1 year after bariatric surgery. Patients of Hospital CUF Tejo, Lisbon, that undergo Roux-en-Y gastric bypass are invited to participate in this study. Men and women between 18 and 65 years old, with a BMI ≥ 35 kg/m2 and at least one severe obesity-related comorbidity, or with a BMI ≥ 40 kg/m2, and who are willing to take 2 capsules of Hafnia alvei HA4597™ probiotic supplements (equivalent to 5 × 107 CFU) vs. placebo per day for 90 days are included in this study. Assessments are carried out at baseline, 3, 6, 9, and 12 months after the surgery. Loss of weight in excess and glycated haemoglobin are considered primary outcomes. In addition, changes in other metabolic and inflammatory outcomes, gut microbiota composition and metabolites, as well as gastrointestinal quality of life are also being assessed during the trial. DISCUSSION: The evidence obtained in this study will provide relevant information regarding the profile of the intestinal microbiota of individuals with severe obesity and the identification of the risk/benefit ratio of the use of Hafnia alvei HA4597™ as an adjunctive treatment in the maintenance of metabolic and weight control one year after the surgical intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05170867. Registered on 28 December 2021.

Confinement During the COVID-19 Pandemic After Metabolic and Bariatric Surgery-Associations Between Emotional Distress, Energy-Dense Foods, and Body Mass Index.

PURPOSE: To estimate the association of emotional distress with both consumption of energy-dense micronutrient-poor foods (EDF) and body mass index (BMI) and the association between EDF consumption and change in BMI, during COVID-19 pandemic in patients with prior bariatric surgery. MATERIALS AND METHODS: This cross-sectional study applied an online structured questionnaire to 75 postoperative bariatric patients during the first Portuguese lockdown. Emotional distress was assessed trough the Hospital Anxiety and Depression Scale (HADS) and dietary intake was evaluated by Food Frequency Questionnaire (FFQ). Self-reported BMI prior to and at the end of confinement was used to compute BMI change. Pre-surgery BMI was computed from measured height and weight from clinical records. RESULTS: After adjustment for education, sex, time since surgery, pre-surgery BMI, and exercise practice, moderate/severe scores in HADS were significantly positively associated with consumption of EDF (ẞ = 0.799; 95% CI: 0.051, 1.546), but not with BMI. Daily EDF consumption significantly increased the odds of maintaining/increasing BMI (OR = 3.34; 95% CI: 1.18, 9.45), instead of decreasing it (reference). Sweets consumption was the only subcategory of EDF significantly positively associated with the odds of a worse outcome in BMI change (OR = 4.01; 95% CI: 1.13, 14.22). CONCLUSIONS: Among postoperative bariatric patients, higher reported levels of emotional distress during confinement are associated with increased EDF consumption. Increased EDF consumption during confinement, particularly sweets, is associated with higher odds of bariatric patients not decreasing their BMI. Additional effort is needed to address inadequate lifestyle behaviors among these patients in the context of the COVID-19 pandemic.

Association of maternal characteristics and behaviours with 4-year-old children's dietary patterns.

This study examined the association of family and maternal characteristics with preschool children's dietary patterns. Trained interviewers evaluated subsample 3422 mothers and children enrolled in the population-based birth cohort Generation XXI (Porto, Portugal, 2005-2006). Maternal characteristics and behaviours (exercise, smoking habits, diet and child-feeding practices) and family characteristics were evaluated. Maternal diet was classified by a dietary score, and children's dietary patterns were identified by latent class analysis. Odds ratios (OR) and confidence intervals (95% CI) were estimated by multinomial regression models. The analysis was based on a framework with four conceptual levels: maternal socio-economic position (SEP) at 12 years, maternal socio-economic and demographic characteristics at child's delivery, family characteristics and maternal behaviours at child's 4 years. Three dietary patterns were identified in children: high in energy-dense foods (EDF); low in foods typically consumed at main meals and intermediate in snacks (Snacking); higher in healthy foods; and lower in unhealthy ones (Healthier, reference). Lower maternal SEP had an overall effect on children's diet (low vs. high SEP; EDF, OR = 1.76, 95% CI: 1.42-2.18; Snacking, OR = 1.73, 95% CI: 1.27-2.35), while maternal education was directly associated with it (≤9 vs. >12 schooling years, EDF, OR = 2.19, 95% CI: 1.70-2.81; Snacking, OR = 2.22, 95% CI: 1.82-3.55). Children whose mothers had worse dietary score were significantly more likely to follow unhealthier patterns (first vs. fourth quartile; EDF, OR = 9.94, 95% CI: 7.35-13.44, P-trend < 0.001; Snacking, OR = 4.21, 95% CI: 2.94-6.05, P-trend < 0.001). Maternal diet was the key factor associated with children's diet, above and beyond socio-economic and demographic characteristics, accounting for one-third of the determination coefficient of the fully adjusted model. At preschool age, interventions should give a particular focus on maternal diet and low SEP groups.

Social and health behavioural determinants of maternal child-feeding patterns in preschool-aged children.

Parental child-feeding attitudes and practices may compromise the development of healthy eating habits and adequate weight status in children. This study aimed to identify maternal child-feeding patterns in preschool-aged children and to evaluate their association with maternal social and health behavioural characteristics. Trained interviewers evaluated 4724 dyads of mothers and their 4-5-year-old child from the Generation XXI cohort. Maternal child-feeding attitudes and practices were assessed through the Child Feeding Questionnaire and the Overt/Covert Control scale. Associations were estimated using linear regression [adjusted for maternal education, body mass index (BMI), fruit and vegetables (F&V) intake and child's BMI z-score]. Principal component analysis defined a three-factor structure explaining 58% of the total variance of maternal child-feeding patterns: perceived monitoring - representing mothers with higher levels of monitoring, perceived responsibility and overt control; restriction - characterizing mothers with higher covert control, restriction and concerns about child's weight; pressure to eat - identifying mothers with higher levels of pressure to eat and overt control. Lower socioeconomic status, better health perception, higher F&V intake and offspring cohabitation were associated with more 'perceived monitoring' mothers. Higher maternal F&V intake and depression were associated with more 'restrictive' mothers. Younger mothers, less educated, with poorer health perception and offspring cohabiting, were associated with higher use of 'pressure to eat'. Maternal socioeconomic indicators and family environment were more associated with perceived monitoring and pressure to eat, whereas maternal health behavioural characteristics were mainly associated with restriction. These findings will be helpful in future research and public health programmes on child-feeding patterns.