Effect of Vitamin C and Protein Supplementation on Plasma Nitrate and Nitrite Response following Consumption of Beetroot Juice.

Beetroot juice is a food high in nitrate and is associated with cardiometabolic health benefits and enhanced exercise performance through the production of nitric oxide in the nitrate−nitrite−nitric oxide pathway. Since various food components influence this pathway, the aim of this trial was to study the effect of beetroot juice alone and in conjunction with vitamin C or protein on the acute response to plasma nitrate and nitrite levels in healthy middle- to older-aged adults. In this cross-over trial, each participant received, in a randomized order, a single dose of Beet It Sport® alone; Beet It Sport®, plus a 200 mg vitamin C supplement; and Beet It Sport® plus 15 g of whey protein. Plasma levels of nitrate and nitrite were determined prior to and at 1 and 3 h after intervention. Log plasma nitrate and nitrite was calculated to obtain data that were normally distributed, and these data were analyzed using two-way within-factors ANOVA, with time and treatment as the independent factors. There were no statistically significant differences for log plasma nitrate (p = 0.308) or log plasma nitrite (p = 0.391) values across treatments. Log plasma nitrate increased significantly from pre-consumption levels after 1 h (p < 0.001) and 3 h (p < 0.001), but plasma nitrate was lower at 3 h than 1 h (p < 0.001). Log plasma nitrite increased from pre to 1 h (p < 0.001) and 3 h (p < 0.001) with log values at 3 h higher than at 1 h (p = 0.003). In this cohort, we observed no differences in log plasma nitrate and nitrite at 1 h and 3 h after co-ingesting beetroot juice with vitamin C or a whey protein supplement compared to beetroot juice alone. Further research needs to be undertaken to expand the blood-sampling time-frame and to examine factors that may influence the kinetics of the plasma nitrate to nitrite efficacy, such as differences in fluid volume and osmolarity between treatments employed.

The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods.

Being overweight or obese is a primary modifiable risk factor that exacerbates disease progression and mobility disability in older knee osteoarthritis (OA) patients. Lifestyle interventions combining exercise with dietary weight loss (EX+DWL) yield meaningful improvements in mobility and weight loss that are superior to EX or DWL alone. Unfortunately, community access to practical, sustainable weight management interventions remains limited and places knee OA patients at increased risk of mobility disability. The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis patients (CLIP-OA), was a two-arm, 18 month randomized-controlled, comparative effectiveness trial designed to contrast the effects of an evidence-based, theory-driven EX+DWL intervention, personalized to patient needs and delivered by our community partners, with those of the Arthritis Foundation's Walk With Ease (WWE) standard of care self-management program in the treatment of knee OA patients with overweight or obesity. The primary outcome of the CLIP-OA trial was mobility performance assessed using the 400-m walk test (400MWT). Secondary outcomes included weight loss, pain, select quality of life and social cognitive variables, and cost-effectiveness of intervention delivery. Findings from the CLIP-OA trial will determine the comparative and cost-effectiveness of the EX+DWL and WWE interventions on key clinical outcomes and has the potential to offer a sustainable medium for intervention delivery that can promote widely accessible weight management among knee OA patients with overweight or obesity. Trial Registration: NCT02835326.

Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health: Trial Design and Methods.

BACKGROUND: Achievement of 5-10% weight loss (WL) among older adults living with obesity considerably improves prognosis of health-related outcomes; however, concomitant declines in bone mineral density (BMD) limit overall benefit by increasing fracture risk. Declines in mechanical loading contribute to WL-associated BMD loss, with pilot data signaling the addition of external weight replacement (via weighted vest use) during intentional WL mitigates bone loss at weight bearing sites to a similar degree as resistance exercise training (RT). Definitive data in support of weighted vest use as a potential strategy to mitigate WL-associated bone loss in this population are needed. METHODS: In the Incorporating Nutrition, Vests, Education, and Strength Training (INVEST) in Bone Health trial (NCT04076618), 192 older adults (60-85 years) who are overweight (BMI ≥ 27 kg/m2) with at least one obesity-related risk factor or obese (BMI = 30-40 kg/m2) will be randomly assigned to participate in one of three 12-month intervention groups: WL alone, WL + weighted vest use (WL + VEST), or WL + RT. The primary aim is to determine the effects of WL + VEST compared to WL alone and WL + RT on indicators of bone health and subsequent fracture risk. DISCUSSION: Determining effective, translatable strategies that minimize bone loss during intentional WL among older adults holds public health potential. The INVEST in Bone Health trial offers an innovative approach for increasing mechanical stress during intentional WL in the absence of RT. If successful, findings from this study will provide evidence in support of a scalable solution to minimize bone loss during intentional WL among older adults with obesity.

Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.

Mounting evidence implicates bariatric surgery as a cause of increased skeletal fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture risk and may be effective in minimizing bone loss associated with bariatric surgery. The main objective of this pilot randomized controlled trial (RCT; Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, treating, and following 24 older patients who had undergone sleeve gastrectomy in a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus placebo) in the prevention of surgical weight-loss-associated bone loss. Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant satisfaction. Study recruitment occurred over 17 months. Seventy participants were referred, with 24 randomized (34% yield) to risedronate (n = 11) or placebo (n = 13). Average age was 56 ± 7 years, 83% were female (63% postmenopausal), and 21% were black. The risedronate group had a higher baseline BMI than the placebo group (48.1 ± 7.2 versus 41.9 ± 3.8 kg/m2). The 10-year fracture risk was low (6.0% major osteoporotic fracture, 0.4% hip fracture); however, three individuals (12.5%, all risedronate group) were osteopenic at baseline. Twenty-one participants returned for 6-month follow-up testing (88% retention) with all (n = 3) loss to follow-up occurring in the risedronate group. Average number of pills taken among completers was 5.9 ± 0.4 and 6.0 ± 0.0 in the risedronate and placebo groups, respectively (p = 0.21), with active participants taking >80% of allotted pills. Five AEs (3.7% AE rate) were reported; one definitely related, four not related, and none serious. All participants reported high satisfaction with participation in the study. Use of bisphosphonates as a novel therapeutic to preserve bone density in patients who had undergone a sleeve gastrectomy appears feasible and well-tolerated. Knowledge gained from this pilot RCT will be used to inform the design of an appropriately powered trial. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/show/NCT03411902. Weight Loss With Risedronate for Bone Health. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

A Mobile Health Behavior Intervention to Reduce Pain and Improve Health in Older Adults With Obesity and Chronic Pain: The MORPH Pilot Trial.

Chronic, multisite pain is a common phenomenon in aging and is associated with a host of negative health outcomes. It is a complex and multifaceted condition that may be exacerbated by weight gain and long periods of inactivity. Unfortunately, older adults suffering from chronic pain have unique barriers limiting access to center-based behavior change interventions. The MORPH study first adapted and iteratively refined an evidence-based group-mediated intervention for delivery in the home via mHealth tools (a smartphone app, teleconferencing software, wearable activity monitor, smart weight scale). This was followed by a pilot randomized controlled trial (RCT) meant to assess feasibility of the MORPH intervention, and to examine initial effects on physical function, pain, weight, and sedentary behavior. We recruited low-active and obese older adults with multisite pain to partake in a series of N-of-1 refinement studies (N = 5 total) or a 12-week pilot RCT delivered largely in the home (N = 28 assigned to active intervention or wait-list control). The refinement phase identified several key technological (e.g., selection of a new smart weight scale) and user interface (e.g., clarification of in-app phrasing) modifications that were made before initiating the RCT phase. Analyses of covariance, controlling for baseline values, sex, and age indicated effects favoring the intervention across all domains of interest: there was a substantially clinically meaningful difference in short physical performance battery scores (0.63 points, η 2 = 0.08), a moderate-to-large difference in PROMIS pain intensity scores (5.52 points, η 2 = 0.12), a large difference in body weight (2.90 kg, η 2 = 0.207), and a moderate effect on adjusted ActivPAL-assessed sedentary time (64.90 min, η 2 = 0.07) with a small effect on steps (297.7 steps, η 2 = 0.01). These results suggest a largely-home delivered movement and weight loss program for older adults with pain is feasible and recommendations are provided for future programs of this nature. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03377634.

Effect of an Energy-Restricted, Nutritionally Complete, Higher Protein Meal Plan on Body Composition and Mobility in Older Adults With Obesity: A Randomized Controlled Trial.

BACKGROUND: Increasing protein content of the diet might be an effective strategy to preserve muscle mass in older adults undergoing caloric restriction, thereby preserving muscle function. METHODS: Ninety-six older adults (70.3 ± 3.7 years, 74% women, 27% African American) with obesity (35.4 ± 3.3 kg/m2; 47% total body fat) were randomized to a 6-month higher protein (providing 1.2-1.5 g/kg/d) weight loss (WL) program, utilizing the Medifast 4&2&1 Plan, or to weight stability (WS). Dual-energy x-ray absorptiometry-acquired total body mass and composition, and fast gait speed over 400 m was assessed at baseline, 3, and 6 months. RESULTS: At baseline, dual-energy x-ray absorptiometry-acquired total body, fat, and lean masses were 95.9 ± 14.6, 44.6 ± 7.6, and 48.7 ± 9.5 kg, respectively, and 400-m gait speed was 1.17 ± 0.20 m/s. Total body mass was significantly reduced in the WL group (-8.17 [-9.56, -6.77] kg) compared with the WS group (-1.16 [-2.59, 0.27] kg), with 87% of total mass lost as fat (WL: -7.1 [-8.1, -6.1] kg; -15.9% change from baseline). A differential treatment effect was not observed for change in lean mass (WL: -0.81 [-1.40, -0.23] kg vs WS: -0.24 [-0.85, 0.36] kg). Four-hundred-meter gait speed was also unchanged from baseline although trends suggest slightly increased gait speed in the WL group [0.01 (-0.02, 0.04) m/s] compared with the WS group [-0.02 (-0.05, 0.01) m/s]. CONCLUSION: Intentional weight loss using a high-protein diet is effective in producing significant total body mass and fat mass loss, while helping preserve lean body mass and mobility, in relatively high-functioning older adults with obesity.

Effect of Exercise Type During Intentional Weight Loss on Body Composition in Older Adults with Obesity.

OBJECTIVE: To examine the long-term effects of exercise modality during weight loss on body composition and associations between body composition and physical function changes. METHODS: Two hundred forty-nine older adults (66.9 ± 4.7 years, 71% women, 32% African American, BMI: 34.4 ± 3.7 kg/m2 ) were randomized to weight loss (WL; n = 82), WL plus aerobic training (WL + AT; n = 86), or WL plus resistance training (WL + RT; n = 81) for 18 months. Dual-energy x-ray absorptiometry-acquired body composition, 400-m walk time, and knee extensor strength were measured at baseline and at 6 and 18 months. RESULTS: Total body mass loss was enhanced when WL was combined with exercise (WL: -5.7 ± 0.7 kg, WL + AT: -8.5 ± 0.7 kg, WL + RT: -8.7 ± 0.7 kg; P < 0.01). Total body fat mass loss was significantly greater in WL + AT (-6.8 ± 0.6 kg, -16.4%) and WL + RT (-7.8 ± 0.5 kg, -19.0%) than WL (-4.8 ± 0.6 kg, -10.9%); both P < 0.01. Lean mass loss was greatest in WL + AT (-1.6 ± 0.3 kg, -3.1%) compared with WL + RT (-0.8 ± 0.3 kg, -1.5%) or WL (-1.0 ± 0.3 kg; -2.0%); both P ≤ 0.02. Change in 400-m walk time was associated with change in fat mass (ß/SD = +6.1 s; P < 0.01), while change in knee extensor strength was associated with change in lean mass (ß/SD = +1.6 Nm; P < 0.01). CONCLUSIONS: WL + RT results in less lean mass lost than WL + AT; WL plus exercise yields greater fat mass loss than WL alone.

Effect of an 18-month physical activity and weight loss intervention on body composition in overweight and obese older adults.

OBJECTIVE: Our primary objective was to determine the long-term effects of physical activity (PA) and weight loss (WL) on body composition in overweight/obese older adults. Secondarily, the association between change in body mass and composition on change in several cardiometabolic risk factors and mobility was evaluated. DESIGN AND METHODS: 288 older (X ± SD: 67.0 ± 4.8 years), overweight/obese (BMI 32.8 ± 3.8 kg/m² ) men and women participated in this 18-month randomized, controlled trial. Treatment groups included PA + WL (n = 98), PA-only (n = 97), and a successful aging (SA) health education control (n = 93). DXA-acquired body composition measures (total body fat and lean mass), conventional biomarkers of cardiometabolic risk, and 400-m walk time were obtained at baseline and 18 months. RESULTS: Fat mass was significantly reduced from (X ± SE) 36.5 ± 8.9 kg to 31.7 ± 9.0 kg in the PA + WL group (p < 0.01), but remained unchanged from baseline in the PA-only (-0.8 ± 3.8 kg) and SA (-0.0 ± 3.9 kg) group. Lean mass losses were three times greater in the PA + WL groups compared to PA-only or SA groups (-2.5 ± 2.8 kg vs. -0.7 ± 2.2 kg or -0.8 ± 2.4 kg, respectively; p < 0.01); yet due to a larger decrease in fat mass, percent lean mass was significantly increased over baseline in the PA + WL groups (2.1% ± 2.6%; p < 0.01). Fat mass loss was primarily responsible for WL-associated improvements in cardiometabolic risk factors, while reduction in body weight, regardless of compartment, was significantly associated with improved mobility. CONCLUSION: This 18-month PA + WL program resulted in a significant reduction in percent body fat with a concomitant increase in percent body lean mass. Shifts in body weight and composition were associated with favorable changes in clinical parameters of cardiometabolic risk and mobility. Moderate PA without WL had no effect on body composition.

The Cooperative Lifestyle Intervention Program-II (CLIP-II): design and methods.

A complication of cardiovascular disease (CVD) and the metabolic syndrome (MetS) among older adults is loss of mobility. The American Heart Association has identified weight management as a core component of secondary prevention programs for CVD and is an important risk factor for physical disability. The American Society for Nutrition and the Obesity Society have highlighted the need for long-term randomized clinical trials to evaluate the independent and additive effects of diet-induced weight loss (WL) and physical activity in older persons on outcomes such as mobility, muscle function, and obesity related diseases. Here we describe the rationale, design, and methods of a translational study, the Cooperative Lifestyle Intervention Program-II (CLIP-II). CLIP-II will randomize 252 obese, older adults with CVD or MetS to a weight loss only treatment (WL), aerobic exercise training (AT)+WL, or resistance exercise training (RT)+WL for 18 months. The dual primary outcomes are mobility and knee extensor strength. The interventions will be delivered by YMCA community partners with our staff as trainers and advisers. This study will provide the first large scale trial to evaluate the effects of diet-induced WL on mobility in obese, older adults with CVD or MetS as compared to WL combined with two different modes of physical activity (AT and RT). Because uncertainty exists about the best approach for promoting WL in older adults due to concerns with the loss of lean mass, the design also permits a contrast between AT+WL and RT+WL on muscle strength.