The OPTIFAST total and partial meal replacement programme reduces cardiometabolic risk in adults with obesity: Secondary and exploratory analysis of the OPTIWIN study.

AIM: The effects of weight loss with a partial or total meal replacement programme (MRP) on atherosclerotic cardiovascular disease (ASCVD) risk factors are not fully understood, in particular in people at higher CV risk. In the 52-week randomized controlled OPTIWIN study in men and women with obesity, meal replacement programme (total for first 26 weeks, partial for the ensuing 26 weeks) with OPTIFAST (OP) resulted in significantly greater weight loss compared with a low-calorie food-based (FB) dietary plan, both as part of a comprehensive lifestyle intervention [OP (n = 135)/FB (n = 138) week 26: -12.4%/-6.0%, p < .001; week 52: -10.5%/-5.5%, p < .001]. Here, we examined effects on ASCVD risk factors and 10-year ASCVD risk. MATERIALS AND METHODS: Participants with body mass index 30-55 kg/m2 and age 18-70 years, and not on anti-obesity medications, were recruited. The effects on systolic and diastolic blood pressure (SBP, DBP), lipid parameters and 10-year ASCVD risk were analysed as changes over time using linear mixed models. Subgroup analyses were conducted for changes in SBP, DBP and ASCVD risk by categories of age (<40, 40-59, ≥60 years), baseline SBP (

Impact on Cardiovascular Health of Using Phentermine/Topiramate in Combination With Laparoscopic Sleeve Gastrectomy in Super Obesity.

INTRODUCTION: Management of patients with BMI≥50 kg/m2 is challenging. In previous work, pre and postoperative pharmacotherapy with phentermine/topiramate plus laparoscopic sleeve gastrectomy (PT + SG) promoted greater weight loss than sleeve gastrectomy (SG) alone at 24 mo postoperatively. This current secondary analysis studied the impact of PT + SG on blood pressure (BP), heart rate, and antihypertensive usage. METHODS: Patients with BMI≥50 kg/m2 planning to have SG (n = 13) were recruited from 2014 to 2016, at an academic medical center in Winston-Salem, North Carolina, for this open-label trial. Participants took phentermine/topiramate (PT; 7.5/46-15/92 mg/d) for ≥3 mo preoperatively and 24 mo postoperatively. The control group (n = 40) underwent SG during the same time frame. We used mixed models for BP and heart rate to compare PT + SG versus SG alone over time, adjusted for age, sex, and initial BP. RESULTS: By 24 mo postoperatively the model adjusted changes in systolic blood pressure/diastolic blood pressure (SBP/DBP) (mm Hg) were -24.44 (-34.46,-14.43)/-28.60 (-40.74,-16.46) in the PT + SG group versus -11.81 (-17.58,-6.05)/-13.89 (-21.32,-6.46) in the control group (SBP P = 0.02; DBP P = 0.03). At baseline 8 (61.5%) participants in the PT + SG arm and 22 (55.0%) in the control group used antihypertensives. Excluding patients lost to follow-up (n = 3), by 24 mo postoperatively, none of the PT + SG participants were on antihypertensives compared to 14 (41.2%) in the control group (P = 0.01). CONCLUSIONS: Patients with BMI≥50 kg/m2 treated with PT + SG had greater improvement in BP with no use of antihypertensive medication at 24 mo postoperatively versus SG alone, where 41% continued medication use. Larger trials are required to evaluate this.

A Proposed Framework for Identifying Nutrients and Food Components of Public Health Relevance in the Dietary Guidelines for Americans.

BACKGROUND: Identification of nutrients of public health concern has been a hallmark of the Dietary Guidelines for Americans (DGA); however, a formal systematic process for identifying them has not been published. OBJECTIVES: We aimed to propose a framework for identifying "nutrients or food components" (NFCs) of public health relevance to inform the DGA. METHODS: The proposed framework consists of 1) defining terminology; 2) establishing quantitative thresholds to identify NFCs; and 3) examining national data. The proposed framework utilizes available data from 3 key data sources or "prongs": 1) dietary intakes; 2) biological endpoints; and 3) clinical health consequences such as prevalence of health conditions, directly or indirectly through validated surrogate markers. RESULTS: In identifying potential NFCs of public health concern, the 2020 DGA Committee developed a decision-tree framework with suggestions for combining the 3 prongs. The identified NFCs of public health concern for Americans ≥1 y old included fiber, calcium (≥2 y old), vitamin D, and potassium for low intakes and sodium, added sugars, and saturated fats (≥2 y old) for high intakes that were associated with adverse health consequences. Iron was identified among infants ages 6-12 mo fed human milk. For reproductive-aged and pregnant females, iron (all trimesters) and folate (first trimester) were identified for low intake, based on dietary and biomarker data (iron) or the severity of the consequence (folic acid and neural tube defects). Among pregnant women, low iodine was of potential public health concern based on biomarker data. Other NFCs that were underconsumed, overconsumed, and pose special challenges were identified across the life course. CONCLUSIONS: The proposed decision-tree framework was intended to streamline and add transparency to the work of this and future Dietary Guidelines Advisory Committees to identify NFCs that need to be encouraged or discouraged in order to help reduce risk of chronic disease and promote health and energy balance in the population.

Dietary Quality Assessed by the HEI-2010 and Biomarkers of Cardiometabolic Disease: An Exploratory Analysis.

Objectives: This study explores relationships between cardiometabolic measures of antioxidant capacity or inflammation and diet quality assessed by the Healthy Eating Index (HEI)-2010 which measures conformity to Dietary Guidelines for Americans. This cross-sectional study was an ancillary analysis of baseline data for a randomized controlled trial with older adults at risk for cardiometabolic disease (ClinicalTrials.gov #NCT00955903). Methods: Community-dwelling older adults (n = 133, 49% male, 70.4 ± 4.8 years) with a body mass index of 30-40 kg/m2 provided a fasted blood sample for measurement of antioxidant capacity, high-sensitivity C-reactive protein, tumor necrosis factor-alpha, and interleukin-6. Dietary data were generated from the mean of three 24-hour recalls. Results: After adjustment for potential confounders, HEI-2010 composite scores were not significantly associated with decreased inflammation or greater antioxidant capacity. In analysis of the 12 components composing the HEI-2010, significant positive association was observed between total dairy and total serum antioxidant capacity (0.043; 95% CI, 0.008-0.069). Significant associations observed in inflammatory markers were between total vegetable and tumor necrosis factor-alpha (-0.078; 95% CI, -0.151 to -0.005), sodium and interleukin-6 (0.091; 95% CI, 0.023-0.158), and scores for combined calories from solid fats, alcoholic beverages, and added sugars and interleukin-6 (0.139; 95% CI, 0.027-0.252). In models adjusting for HEI-2010 composite score when significant associations were observed between component scores and biomarkers, two of six associations were strengthened by adding the composite score as a potential confounder. Conclusions: Largely null findings along with those inconsistent with scientific expectations suggest caution in extrapolating adherence to the HEI-2010 with an individual's inflammatory or antioxidant status. Results merit additional investigation with other biomarkers of chronic disease and emphasis on dietary patterns given potential synergy within food combinations.

Perception of Obesity in the Latino Population: Implications for Weight Loss Clinical Trials.

Ethnic minorities in the United States have a higher prevalence of obesity, with higher levels reported in Latinos/Hispanics. A qualitative study was done to understand perceptions of obesity and identify factors that may enhance the attractiveness of a behavioral weight-loss intervention in the Latino community. Weight loss trials designed to target the Latino/Hispanic population may benefit by considering the Latino/Hispanic perception of the problem, the barriers to weight loss, and for study participation that may be specific to this population.

Associations of neighborhood area level deprivation with the metabolic syndrome and inflammation among middle- and older- age adults.

BACKGROUND: The study examines the association of neighborhood socioeconomic deprivation and metabolic syndrome with inflammation. METHODS: The analysis included 19, 079 black and white participants from the REasons for Geographic And Racial Differences in Stroke Study who were age > 45 years at baseline. Logistic regression examined whether neighborhood deprivation was associated with increased odds of METS and CRP-MetS. RESULTS: Among black adults, residing in the most deprived neighborhoods was associated with increased odds of obesity (p < .01), lower HDL (p < .001), high blood pressure (p < .01), elevated fasting glucose (p < .001), inflammation (p < .01), and CRP-MetS (p < .001). Among white adults, neighborhood deprivation was associated with higher waist circumference (p < .001), lower HDL (p < .001), higher triglycerides (p < .01), higher glucose (p < .001), higher BMI (p < .0001), higher blood pressure (p = .01), METS (p < .001), inflammation (p < .01) and CRP-MetS (p < .001). CONCLUSIONS: These findings highlight the role of neighborhood socioeconomic deprivation on METS and CRP-MetS for black and white adults. Interventions tailored to address the contextual effects of deprived neighborhoods may reduce the observed neighborhood disparities.

Psychosocial predictors of weight regain in the weight loss maintenance trial.

This study's purpose was to identify psychosocial predictors of weight loss maintenance in a multi-site clinical trial, following a group-based weight loss program. Participants (N = 1025) were predominately women (63%) and 38% were Black (mean age = 55.6 years; SD = 8.7). At 12 months, higher SF-36 mental health composite scores were associated with less weight regain (p < .01). For Black participants, an interaction existed between race and friends' encouragement for exercise, where higher exercise encouragement was related to more weight regain (p < .05). At 30 months, friends' encouragement for healthy eating was associated with more weight regain (p < .05), whereas higher SF-36 mental health composite scores were related to less weight regain (p < .0001). Perceived stress and select health-related quality of life indices were associated with weight regain; this relationship varied across gender, race, and treatment conditions. Temporal changes in these variables should be investigated for their impact on weight maintenance.

Game changers: do new medications make lifestyle-based treatment of obesity obsolete?

Historically, obesity was viewed as a lifestyle disease, with an associated lifestyle solution, and approaches that embody the "eat less, move more" idea have dominated obesity treatment recommendations for over half a century. Meanwhile, the prevalence and severity of obesity continue to increase globally. Enter the so-called "game changers": glucagon-like peptide-1 receptor agonists. In the media frenzy around these and other new antiobesity medications in the pipeline, lifestyle-based treatment researchers and practitioners may find themselves wondering whether behavioral approaches to obesity will become obsolete in this new therapeutic era. In this Perspective, the authors contend that medical approaches impact physiologic pathways to support the success of behavioral approaches. Similarly, behavioral approaches can improve weight loss-adjacent outcomes that are not addressed by medication. Thus, the two approaches are complementary and must coexist if we are to make a significant, population-level impact on the obesity epidemic.

Phentermine in the Modern Era of Obesity Pharmacotherapy: Does It Still Have a Role in Treatment?

PURPOSE OF REVIEW: This review provides an overview of the history, mechanism of action, and expected treatment effects of the anti-obesity medication (AOM), phentermine. It also includes a summary of recent research and practical guidance for prescribing clinicians. RECENT FINDINGS: Recent research on phentermine is sparse and consists primarily of observational studies with methodologic limitations. These studies suggest that phentermine use is associated with clinically significant weight loss in adults and that the medication is generally well tolerated. Large-scale observational studies evaluating phentermine's safety have not identified an increased risk of cardiovascular events or elevations in blood pressure. There is no data to support the notion that phentermine is addictive. Although it remains the most commonly prescribed AOM in the USA, phentermine has little rigorous research to support its efficacy and safety in long-term treatment, which creates a dilemma with guideline-recommended chronic use of AOMs. While we await forthcoming conclusive data on this front, clinicians may consider using phentermine long-term in selected patients, if such prescribing is consistent with local regulatory statutes.

Nutritional considerations with antiobesity medications.

The improved efficacy and generally favorable safety profile of recently approved and emerging antiobesity medications (AOMs), which result in an average weight reduction of ≥15%, represent significant advancement in the treatment of obesity. This narrative review aims to provide practical evidence-based recommendations for nutritional assessment, management, and monitoring of patients treated with AOMs. Prior to treatment, clinicians can identify preexisting nutritional risk factors and counsel their patients on recommended intakes of protein, dietary fiber, micronutrients, and fluids. During treatment with AOMs, ongoing monitoring can facilitate early recognition and management of gastrointestinal symptoms or inadequate nutrient or fluid intake. Attention should also be paid to other factors that can impact response to treatment and quality of life, such as physical activity and social and emotional health. In the context of treatment with AOMs, clinicians can play an active role in supporting their patients with obesity to improve their health and well-being and promote optimal nutritional and medical outcomes.

Caregiver perceptions of the food marketing environment of African-American 3-11-year-olds: a qualitative study.

OBJECTIVE: To assess caregivers' perceptions of the extent to which the food marketing environment influences food consumption among African-American children (aged 3­11 years) in order to generate potential strategies to make the marketing environment more favourable to healthier eating. DESIGN: Individual semi-structured interviews with caregivers were conducted by trained community leaders to ascertain their awareness of and perceptions about food marketing environments contributing to African-American children's food consumption. SETTING: Six predominantly African-American communities in metro Birmingham, Alabama, USA with high proportions of school-age children and lower-income residents. SUBJECTS: Caregivers (n 25) were predominantly female (93 %) and either parents/guardians (64 %) or grandparents (28 %) of African-American children aged 3­11 years. Caregiver mean age was 43 years and 46 % had lived in their current residence for over 10 years. RESULTS: Caregivers reported all aspects of the food marketing matrix as supporting unhealthy eating among African-American youth. Child preference for foods higher in fat and sugar, lower pricing of less healthy foods, limited access to healthier food retailers and targeted advertisements were particularly influential on the food selection, acquisition and consumption of children. Company loyalty, corporate sponsorship of local events and conflicts over parental v. food company responsibility contributed to less consensus about the overall impact (positive or negative) of food companies in African-American communities. CONCLUSIONS: While caregivers perceived aspects of their food marketing environments as primarily contributing to unhealthy eating among African-American children, framing the demand for changes in the food marketing environments of African-American youth may be particularly challenging.

Obesity among African American people in the United States: A review.

Obesity is a growing public health crisis in the United States and is associated with a substantial disease burden due to an increased risk for multiple complications, including cardiovascular and metabolic diseases. As highlighted in this review, obesity disproportionately affects the African American population, women in particular, regardless of socioeconomic status. Structural racism remains a major contributor to health disparities between African American people and the general population, and it limits access to healthy foods, safe spaces to exercise, adequate health insurance, and medication, all of which impact obesity prevalence and outcomes. Conscious and unconscious interpersonal racism also impacts obesity care and outcomes in African American people and may adversely affect interactions between health care practitioners and patients. To reduce health disparities, structural racism and racial bias must be addressed. Culturally relevant interventions for obesity management have been successfully implemented that have shown benefits in weight management and risk-factor reduction. Strategies to improve health care practitioner-patient engagement should also be implemented to improve health outcomes in African American people with obesity. When managing obesity in African American people, it is critical to take a holistic approach and to consider an individual's social and cultural context in order to implement a successful treatment strategy.

Strategies to reduce the onset of sleeve gastrectomy associated bone loss (STRONG BONES): Trial design and methods.

Background: Despite recognized improvements in obesity-related comorbidities, mounting evidence implicates surgical weight loss in the onset of skeletal fragility. Sleeve gastrectomy (SG) is the most commonly performed bariatric procedure and is associated with 3-7% axial bone loss in the year following surgery. Bisphosphonates are FDA-approved medications for the prevention and treatment of age-related bone loss and may represent a strategy to reduce bone loss following SG surgery. Methods: The Strategies to Reduce the Onset of Sleeve Gastrectomy Associated Bone Loss (STRONG BONES) trial (NCT04922333) is designed to definitively test whether monthly administration of the bisphosphonate, risedronate, for six months can effectively counter SG-associated bone loss. Approximately 120 middle-aged and older (≥40 years) SG patients will be randomized to six months of risedronate or placebo treatment, with skeletal outcomes assessed at baseline, six, and 12-months post-surgery. The primary outcome of the trial is 12-month change in total hip areal bone mineral density (aBMD), measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at other skeletal sites and quantitative computed tomography (QCT) derived changes in bone quality. Change in muscle mass and function will also be assessed, as well as biomarkers of bone health, turnover, and crosstalk, providing mechanistic insight into intervention-related changes to the bone-muscle unit. Discussion: Results from the STRONG BONES trial have the potential to influence current clinical practice by determining the ability of bisphosphonate use to mitigate bone loss and concomitant fracture risk in middle-aged and older SG patients.

Risedronate use may blunt appendicular lean mass loss secondary to sleeve gastrectomy: Results from a pilot randomized controlled trial.

Background: Despite robust weight loss and cardiometabolic benefit, lean mass loss following sleeve gastrectomy (SG) confers health risk. Bisphosphonates are a potential therapeutic agent for lean mass maintenance. Thus, our objective was to explore the effect of six months of risedronate (vs placebo) on change in dual energy x-ray absorptiometry (DXA) and computed tomography (CT) derived lean mass metrics in the year following SG. Methods: 24 SG patients were randomized to six months of 150 mg oral risedronate or placebo capsules (NCT03411902). Body composition was assessed at baseline and six months with optional 12-month follow-up using whole-body DXA and CT at the lumbar spine and mid-thigh. Group treatment effects and 95% CIs were generated from a mixed model using contrast statements at six and 12 months, adjusted for baseline values. Results: Of 24 participants enrolled [55.7±6.7 years (mean±SD), 79% Caucasian, 83% women, body mass index (BMI) 44.7±6.3kg/m2], 21 returned for six-month testing, and 14 returned for 12-month testing. Six-month weight loss was -16.3 kg (-20.0, -12.5) and -20.9 kg (-23.7, -18.1) in the risedronate and placebo groups, respectively (p=.057). Primary analysis at six-months revealed a non-significant sparing of appendicular lean mass in the risedronate group compared to placebo [-1.2 kg (-2.3, -0.1) vs -2.1 kg (-3.0, -1.2)]; p=.20. By 12-months, the risedronate group displayed no change in appendicular lean mass from baseline [-0.5 kg (-1.5, 0.6)]; however, the placebo group experienced significantly augmented loss [-2.9 kg (-3.6, -2.1)]. Conclusion: Pilot data indicate risedronate treatment may mitigate appendicular lean mass loss following SG. Further study is warranted.

Sex hormone changes during weight loss and maintenance in overweight and obese postmenopausal African-American and non-African-American women.

INTRODUCTION: Changes in sex hormones with weight loss might have implications for breast cancer prevention but have not been examined extensively, particularly in African-American (AA) women. METHODS: We conducted a prospective study of 278 overweight/obese postmenopausal women (38% AA) not taking hormone therapy within the Weight Loss Maintenance Trial. All participants lost at least 4 kg after a 6-month weight-loss phase and attempted to maintain weight loss during the subsequent 12 months. We evaluated the percentage changes in estrone, estradiol, free estradiol, testosterone, free testosterone, androstenedione, dehydroepiandrosterone sulfate and sex hormone-binding globulin (SHBG) using generalized estimating equations. RESULTS: In all study phases, AA women had higher levels of estrogen and testosterone concentrations, independent of adiposity. On average, participants lost 7.7 kg during the weight-loss phase, and concentrations of estrone (-5.7%, P = 0.006), estradiol (-9.9%, P <0.001), free estradiol (-13.4%, P <0.0001), and free testosterone (-9.9%, P <0.0001) decreased, while the SHBG concentration (16.2%, P <0.001) increased. Weight change did not significantly affect total testosterone or other androgen concentrations. Compared with non-AA women, AA women experienced less change in estrogens per kilogram of weight change (that is, per 1 kg weight loss: estrone, -0.6% vs. -1.2%, P-interaction = 0.10; estradiol, -1.1% vs. -1.9%, P-interaction = 0.04; SHBG, 0.9% vs. 1.6%, P-interaction = 0.006; free estradiol, -1.4% vs. -2.1%, P-interaction = 0.01). CONCLUSION: To the best of our knowledge this is the first study to examine and compare the effects of intentional weight loss and maintenance on a panel of sex hormones in AA women and non-AA women. Although speculative, these data suggest hormonal differences may contribute to different racial patterns of breast cancer incidence and mortality and encourage further investigations to understand the long-term effects of weight loss on sex hormones in obese postmenopausal women. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00054925.

Changes in adiponectin:leptin ratio among older adults with obesity following a 12-month exercise and diet intervention.

BACKGROUND: Excess adiposity is characterized by alterations in adipokine secretion such that circulating leptin concentrations are increased with reductions in adiponectin. An emerging biomarker for the assessment of this adipose tissue (AT) dysfunction is the adiponectin:leptin (AL) ratio. A low AL ratio may be suggestive of dysfunctional AT and, consequently, a heightened cardiometabolic disease risk. This ancillary study investigated the relationship between the AL ratio and cardiometabolic health among community-dwelling older adults with obesity, as well as the effects of a 12-month exercise and diet intervention on changes in the AL ratio. METHODS: Participants (n = 163, 70.2 ± 4.7 years, 38.0% male) were randomized to the exercise only group, exercise + nutrient-dense weight maintenance group (exercise + weight maintenance), or exercise + nutrient-dense caloric restriction of 500 kcal/d group (exercise + intentional weight loss) (clinicaltrials.gov #NCT00955903). Total and regional adiposity as determined by magnetic resonance imaging (MRI) and dual-energy X-ray absorptiometry (DXA), anthropometrics, and cardiometabolic biomarkers were assessed at baseline and 12 months. RESULTS: The AL ratio was significantly (p < 0.05) inversely correlated with body mass index, waist circumference, measures of adiposity, and insulin among all participants at baseline. Among females only, significant positive and inverse correlations were also observed between this ratio and high-density lipoprotein cholesterol and the inflammatory biomarkers high sensitivity C-reactive protein and interleukin-6, respectively. While controlling for biological sex, a significant time by intervention group interaction effect (p < 0.05) was observed such that the AL ratio significantly increased from baseline to study completion among participants in the exercise + weight maintenance group and exercise + intentional weight loss group. Post hoc analysis revealed that the exercise + intentional weight loss group exhibited a significantly greater AL ratio at study completion compared to other groups (p < 0.05 all). CONCLUSIONS: Results are in support of the AL ratio as a measure of AT dysfunction among older adults. Furthermore, results suggest that a 12-month exercise and diet intervention with intentional weight loss assists in improving the AL ratio in this population.

Relative fat mass assessment estimates changes in adiposity among female older adults with obesity after a 12-month exercise and diet intervention.

BACKGROUND/OBJECTIVES/INTRODUCTION: It is imperative to accurately estimate whole body fat percentage (%fat) to understand the deleterious nature of excess adiposity on cardiometabolic disease risk. Cost and accessibility often preclude the use of advanced imaging methods like dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). Relative fat mass (RFM) is an emerging estimator of whole body %fat based on waist circumference, height, and biological sex. The purpose of this ancillary study was to examine the relationship between RFM and gold-standard measures of adiposity among community-dwelling older adults with obesity and to evaluate if changes in RFM reflect changes in %fat following a 12-month lifestyle intervention (clinicaltrials.gov #NCT00955903). PATIENTS/MATERIALS AND METHODS: Participants (N = 163, 37.4% male, 70.3 ± 4.7 years) were randomized to the exercise only group, exercise + nutrient-dense weight maintenance group, or exercise + nutrient-dense energy restriction of 500 kcal/d group. Total and regional adiposity assessed by DXA and MRI, as well as anthropometrics, were evaluated at baseline and 12 months. RESULTS: RFM was significantly positively correlated with DXA whole body %fat and DXA trunk %fat at baseline. Equivalence testing revealed that RFM was considered equivalent to DXA whole body %fat for females only. Additionally, from baseline to 12 months, a significant reduction in RFM was observed among female participants in the exercise + energy restriction group only. Changes in RFM were significantly correlated with changes in DXA whole body %fat, DXA trunk fat, and total abdominal fat tissue determined by MRI. CONCLUSION: Results support the use of RFM as an estimate of whole body %fat where advanced imaging techniques are not feasible. Furthermore, results suggest that this index is sensitive to changes in fat mass over 12 months in female older adults with obesity. KEY MESSAGESRelative fat mass (RFM), an emerging estimator of whole body %fat based on waist circumference, height, and biological sex, was intentionally developed to be a simple estimate of adiposity that overcomes limitations of measures like body mass index.In the current study, results from correlations and agreement analyses support the use of RFM to estimate whole-body fat percentage in a community-dwelling older adult population with obesity when advanced methods, namely dual-energy X-ray absorptiometry, are not feasible.Significant reductions in RFM were also observed over a 12-month period that was significantly correlated with changes in whole body fat percentage; thus, supporting the sensitivity of RFM to lifestyle changes.

Rationale and study protocol for a randomized controlled feeding study to determine the structural- and functional-level effects of diet-specific interventions on the gut microbiota of non-Hispanic black and white adults.

BACKGROUND: Colorectal cancer (CRC), the third leading cause of cancer-related deaths in the US, has been associated with an overrepresentation or paucity of several microbial taxa in the gut microbiota, but causality has not been established. Black men and women have among the highest CRC incidence and mortality rates of any racial/ethnic group. This study will examine the impact of the Dietary Approaches to Stop Hypertension (DASH) diet on gut microbiota and fecal metabolites associated with CRC risk. METHODS: A generally healthy sample of non-Hispanic Black and white adults (n = 112) is being recruited to participate in a parallel-arm randomized controlled feeding study. Participants are randomized to receive the DASH diet or a standard American diet for a 28-day period. Fecal samples are collected weekly throughout the study to analyze changes in the gut microbiota using 16 s rRNA and selected metagenomics. Differences in bacterial alpha and beta diversity and taxa that have been associated with CRC (Bacteroides, Fusobacterium, Clostridium, Lactobacillus, Bifidobacterium, Ruminococcus, Porphyromonas, Succinivibrio) are being evaluated. Covariate measures include body mass index, comorbidities, medication history, physical activity, stress, and demographic characteristics. CONCLUSION: Our findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across non-Hispanic Black and non-Hispanic White adults. These results can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases including CRC. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov, identifier NCT04538482, on September 4, 2020 (https://clinicaltrials.gov/ct2/show/NCT04538482).

Changes in Cardiometabolic Risk Among Older Adults with Obesity: An Ancillary Analysis of a Randomized Controlled Trial Investigating Exercise Plus Weight Maintenance and Exercise Plus Intentional Weight Loss by Caloric Restriction.

BACKGROUND: Obesity imposes risk to cardiometabolic health; however, intentional weight loss among older adults with obesity remains controversial. OBJECTIVE: To explore the influence of exercise plus weight maintenance and exercise plus intentional weight loss by caloric restriction on changes in cardiometabolic risk among older adults with obesity assessed by four risk-scoring tools. DESIGN: Using longitudinal data from the Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults study (CROSSROADS) (ClinicalTrials.gov identifier: NCT00955903; May 2009 to October 2014), scores were calculated using baseline and 12-month data according to criteria from the International Diabetes Federation, National Cholesterol Education Program's Adult Treatment Panel, Framingham Risk Score, and Cardiometabolic Disease Staging. PARTICIPANTS AND SETTING: Participants (39% men, 23% African American, aged 70.2 ± 4.7 years) were randomized to exercise (n = 48), exercise plus nutrient-dense weight maintenance diet (n = 44), or exercise plus weight loss by moderate caloric restriction (n = 42). MAIN OUTCOME MEASURES: To evaluate effects of exercise plus weight maintenance and exercise plus intentional weight loss on changes in cardiometabolic risk. STATISTICAL ANALYSES PERFORMED: Generalized estimating equations were used to assess changes in risk with ethnicity, biological sex, and age as covariates. RESULTS: Group-time interaction was only significant for Framingham and Cardiometabolic Disease Staging (P = 0.005 and 0.041, respectively). Upon post hoc analysis, significant within-group improvements in Framingham scores were observed for exercise plus weight maintenance (P < 0.001; r = -1.682) and exercise plus weight loss (P = 0.020; r = -0.881). In analysis of between-group differences in Framingham scores, significant decreases were observed in the exercise plus weight maintenance group (P = 0.001; r = -1.723) compared with the exercise group. For Cardiometabolic Disease Staging, the exercise plus weight loss group had significant within-group improvements (P = 0.023; r = -0.102). For between-group differences in Cardiometabolic Disease Staging, the exercise plus weight loss group showed significant risk reduction (P = 0.012; r = -0.142) compared with the exercise group. CONCLUSIONS: Among risk scores evaluated, Framingham and Cardiometabolic Disease Staging showed significantly greater sensitivity to change in cardiometabolic risk. Older adults with obesity can significantly lower cardiometabolic risk through exercise plus weight maintenance or exercise plus weight loss by moderate caloric restriction.