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1.
Sci Rep ; 14(1): 2682, 2024 02 01.
Article in English | MEDLINE | ID: mdl-38302511

ABSTRACT

Both food insecurity and home and wild food procurement (HWFP), including gardening, increased in many countries during the COVID-19 pandemic; yet little evidence has demonstrated what impact HWFP had on food security. Using data from a representative sample of nearly 1000 residents in the two most rural US states (Vermont and Maine) conducted via an online survey in Spring/Summer 2021, as well as matching techniques, we compare food security outcomes among households who did and did not participate in HWFP in the first year of the pandemic. Nearly 60% of respondents engaged in HWFP in some way during the first year of the pandemic, with food insecure households more likely to do HWFP. Furthermore, HWFP early in the COVID-19 pandemic is associated with improved food security in the 9-12 months later, though these improvements were primarily associated with newly, not chronically, food insecure households. Newly and chronically food insecure households were more likely to want to continue these activities in the future, but also exhibited greater barriers to land access and costs associated with these activities. These results suggest that HWFP may provide food security improvements for certain households that utilize them, especially during crisis situations. Future research about HWFP should continue to explore multiple HWFP strategies, their barriers, and their potentially myriad relationships to food security, diet, and health outcomes, especially with longitudinal data.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Pandemics , Food Supply , Food , Food Security
2.
BMJ Open ; 13(12): e077520, 2023 12 21.
Article in English | MEDLINE | ID: mdl-38135330

ABSTRACT

INTRODUCTION: There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers. METHODS AND ANALYSIS: We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women's Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25-29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation. ETHICS AND DISSEMINATION: The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future. TRIAL REGISTRATION NUMBER: NCT0555925.


Subject(s)
Overweight , Weight Reduction Programs , Adult , Female , Humans , Young Adult , Body Mass Index , Obesity/prevention & control , Overweight/prevention & control , Patient-Centered Care , Weight Reduction Programs/methods
3.
Front Psychol ; 13: 847099, 2022.
Article in English | MEDLINE | ID: mdl-35401335

ABSTRACT

Background: Scientific literature on posttraumatic growth (PTG) after terrorist attacks has primarily focused on persons who had not been directly exposed to terrorist attacks or persons who had been directly exposed to them, but who were assessed few months or years after the attacks. Methods: We examined long-term PTG in 210 adults directly exposed to terrorist attacks in Spain a mean of 29.6 years after the attacks (range: 2-47 years). The participants had been injured by a terrorist attack (38.6%) or were first-degree relatives of people who had been killed or injured by a terrorist attack (41.4% and 20%, respectively). They completed diagnostic measures of emotional disorders and measures of PTSD and depression symptomatology, optimism, and PTG. Results: Multiple regression analyses revealed gender differences (women reported higher levels of PTG than did men) and a positive linear relationship between PTG and cumulative trauma after the terrorist attack. Some PTG dimensions were significantly associated with PTSD symptomatology, these associations being linear, not curvilinear. However, PTG was not associated with depression symptomatology, diagnosis of emotional disorders, age, elapsed time since the attack, or optimism. In comparison with survivors assessed 18 years after the 1995 Oklahoma City bombing, Spanish victims of terrorism showed higher levels of appreciation of life, but lower levels of relating to others and spiritual change. Conclusion: The findings underscore the influence of gender on PTG and provide support to the hypothesis that some emotional distress may be a necessary condition of PTG. Future studies on PTG after terrorist attacks should take into consideration the characteristics of the terrorist attack itself and the contexts of violence and threat in which it occurred. The political, social, and cultural characteristics of the community affected by it and the profile and characteristics of other traumatic events suffered after the attack should also be taken into account in further research.

4.
Nutrients ; 14(7)2022 Mar 24.
Article in English | MEDLINE | ID: mdl-35405972

ABSTRACT

This study assessed changes in household food insecurity throughout the first year of the COVID-19 pandemic in a cohort of adults in the state of Vermont, USA, and examined the socio-demographic characteristics associated with increased odds of experiencing food insecurity during the pandemic. We conducted three online surveys between March 2020 and March 2021 to collect longitudinal data on food security, use of food assistance programs, and job disruptions during the COVID-19 pandemic. Food security was measured using the USDA six-item module. Among the 441 respondents, food insecurity rates increased significantly during the pandemic and remained above pre-pandemic levels a year after the start of the pandemic. Nearly a third (31.6%) of respondents experienced food insecurity at some point during the first year of the pandemic, with 53.1% of food-insecure households being classified as newly food-insecure. The odds of experiencing food insecurity during the pandemic varied based on socio-demographic factors. Households with children (OR 5.5, 95% CI 1.782−16.936, p < 0.01), women (OR 8.1, 95% CI 1.777−36.647, p < 0.05), BIPOC/Hispanic respondents (OR 11.8, 95% CI 1.615−85.805, p < 0.05), and households experiencing a job disruption (OR 5.0, 95% CI 1.583−16.005, p <0.01) had significantly higher odds of experiencing food insecurity during the first year of the COVID-19 pandemic, while respondents with a college degree (OR 0.08; 95% CI 0.025−0.246; p < 0.001) and household income of ≥USD 50,000 (OR 0.01; 95% CI 0.003−0.038; p < 0.001) had lower odds of experiencing food insecurity. These findings indicate that food insecurity continued to be a significant challenge one year after the start of the pandemic, which is important, given the adverse health impacts associated with food insecurity and health disparities among certain socio-demographic groups.


Subject(s)
COVID-19 , Pandemics , Adult , COVID-19/epidemiology , Child , Cross-Sectional Studies , Female , Food Security , Food Supply , Humans , SARS-CoV-2 , Vermont/epidemiology
6.
Am J Clin Nutr ; 114(3): 1189-1199, 2021 09 01.
Article in English | MEDLINE | ID: mdl-34008842

ABSTRACT

BACKGROUND: Obese and malabsorptive patients have difficulty increasing serum 25-hydroxyvitamin D [25(OH)D] after taking vitamin D supplementation. Since 25(OH)D is more hydrophilic than vitamin D, we hypothesized that oral 25(OH)D supplementation is more effective in increasing serum 25(OH)D concentrations in these patients. OBJECTIVES: We aimed to investigate the pharmacokinetics of oral 25-hydroxyvitamin D3 [25(OH)D3] and oral vitamin D3 in healthy participants with differing BMI and malabsorptive patients. METHODS: A randomized, double-blind crossover trial was performed in 6 malabsorptive patients and 10 healthy participants who were given 900 µg of either vitamin D3 or 25(OH)D3 orally followed by a pharmacokinetic study (PKS). After ≥28 d from the first dosing, each participant returned to receive the other form of vitamin D and undergo another PKS. For each PKS, serum vitamin D3 and 25(OH)D3 were measured at baseline and at 2, 4, 6, 8, and 12 h and days 1, 2, 3, 7, and 14. Pharmacokinetic parameters were calculated. RESULTS: Data were expressed as means ± SEMs. The PKS of 900 µg vitamin D3 revealed that malabsorptive patients had 64% lower AUC than healthy participants (1177 ± 425 vs. 3258 ± 496 ng · h/mL; P < 0.05). AUCs of 900 µg 25(OH)D3 were not significantly different between the 2 groups (P = 0.540). The 10 healthy participants were ranked by BMI and categorized into higher/lower BMI groups (5/group). The PKS of 900 µg vitamin D3 showed that the higher BMI group had 53% lower AUC than the lower BMI group (2089 ± 490 vs. 4427 ± 313 ng · h/mL; P < 0.05), whereas AUCs of 900 µg 25(OH)D3 were not significantly different between the 2 groups (P = 0.500). CONCLUSIONS: Oral 25(OH)D3 may be a good choice for managing vitamin D deficiency in malabsorption and obesity. This trial was registered at clinicaltrials.gov as (NCT03401541.


Subject(s)
Calcifediol/administration & dosage , Calcifediol/pharmacokinetics , Cholecalciferol/administration & dosage , Cholecalciferol/pharmacokinetics , Malabsorption Syndromes/metabolism , Administration, Oral , Adult , Area Under Curve , Body Mass Index , Calcium-Regulating Hormones and Agents/administration & dosage , Calcium-Regulating Hormones and Agents/pharmacokinetics , Cross-Over Studies , Double-Blind Method , Female , Half-Life , Humans , Male , Middle Aged , Pilot Projects , Vitamins/administration & dosage , Vitamins/pharmacokinetics
7.
Am J Public Health ; 111(4): 663-666, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33600252

ABSTRACT

A safety-net hospital in Boston, Massachusetts, made adaptations to its Nourishing Our Community Program to accommodate restrictions brought on by the COVID-19 pandemic to continue providing food and education to patients. While participation in programs decreased overall, some of the adaptations made, including virtual classes and food pantry home delivery, were well received and are planned to be maintained after the pandemic subsides. By making adjustments to operational procedures, the Nourishing Our Community Program continued to reach its underserved population despite pandemic challenges.


Subject(s)
COVID-19 , Food Assistance , Medically Underserved Area , Resource Allocation , Safety-net Providers , Vulnerable Populations , Boston , Humans , Massachusetts , Poverty , Urban Population
8.
Surgery ; 169(3): 617-622, 2021 03.
Article in English | MEDLINE | ID: mdl-33268071

ABSTRACT

BACKGROUND: Introduction of gut flora into the biliary system is common owing to biliary stenting in patients with obstructing pancreatic head cancer. We hypothesize that alteration of biliary microbiome modifies bile content that modulates pancreatic cancer cell survival. METHODS: Human bile samples were collected during pancreaticoduodenectomy. Bacterial strains were isolated from contaminated (stented) bile and identified using 16S ribosomal RNA sequencing. Human pancreatic cancer cells (AsPC1, CFPAC, Panc1) were treated for 24 hours with sterile (nonstented) bile, contaminated (stented) bile, and sterile bile preincubated with 106 colony forming unit of live bacteria isolated from contaminated bile or a panel of bile acids for 24 hours at 37°C, and evaluated using CellTiter-Blue Cell Viability Assay (Promega Corp. Madison, WI). Human bile (30-50 µl/mouse) was coinjected intraperitoneally with 105 Panc02 mouse pancreatic cancer cells in C57BL6/N mice to evaluate the impact of bile on peritoneal metastasis 3 to 4 weeks after tumor challenge. RESULTS: While all bile samples significantly reduced peritoneal metastasis of Panc02 cells in mice, some contaminated bile samples had diminished antitumor effect. All sterile bile (n = 4) reduced pancreatic cancer cell survival in vitro. Only 40% (2/5) of contaminated bile samples had significant effect. Preincubation of sterile bile with live Enterococcus faecalis or Streptococcus oralis modified the antitumor effect of sterile bile. These changes were not observed with culture media preincubated with live bacteria, suggesting live gut bacteria can modify the antitumor components present in bile. Conjugated bile acids were more potent than unconjugated cholic acid in reducing pancreatic cancer cell survival. CONCLUSION: Alteration of bile microbiome from biliary stenting has a direct impact on pancreatic cancer cell survival. Further study is warranted to determine if this microbiome shift alters tumor microenvironment.


Subject(s)
Bacterial Infections/etiology , Bile/microbiology , Pancreatic Neoplasms/complications , Animals , Bile Acids and Salts/pharmacology , Cell Line, Tumor , Cell Survival/drug effects , Disease Models, Animal , Dose-Response Relationship, Drug , Female , Gastrointestinal Microbiome/drug effects , Heterografts , Humans , Male , Mice , Pancreatic Neoplasms/mortality , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Pancreaticoduodenectomy/methods , Surgical Wound Infection/etiology
9.
Ann Surg Oncol ; 27(13): 5065-5071, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32648179

ABSTRACT

BACKGROUND: Disease burden in patients with peritoneal carcinomatosis (PC) is difficult to estimate. We evaluate whether peritoneal cell-free tumor DNA can be used as a measure of disease burden. PATIENTS AND METHODS: Malignant ascites or peritoneal lavage fluids were collected from patients with PC under approved IRB protocol. Cell-free DNA was extracted from peritoneal fluid. Droplet digital PCR (ddPCR) was performed using a commercially available KRAS G12/G13 screening kit. Mutant allele frequency (MAF) was calculated based on the numbers of KRAS wild-type and mutant droplets. Clinicopathological, treatment and outcome data were abstracted and correlated with MAF of cell-free KRAS mutant DNA. RESULTS: Cell-free KRAS mutant DNA was detected in 15/37 (40%) malignant peritoneal fluids with a MAF of 0.1% to 26.2%. While peritoneal cell-free KRAS mutant DNA was detected in all the patients with KRAS mutant tumors (N = 10), 3/16 (19%) patients with KRAS wild-type tumors also had peritoneal cell-free KRAS mutant DNA. We also found that 71% (5/7) of patients with disease amenable to cytoreductive surgery (CRS) had a MAF of < 1% (median: 0.5%, range: 0.1-4.7%), while 75% (6/8) of patients with unresectable disease had a MAF of > 1% (median: 4.4%, range: 0.1-26.2%). CONCLUSIONS: This pilot proof-of-principle study suggests that peritoneal cell-free tumor DNA detected by ddPCR may enable prediction of disease burden and a measure of disease amenable to CRS in patients with PC.


Subject(s)
Peritoneal Neoplasms , Biomarkers, Tumor/genetics , Circulating Tumor DNA , Humans , Peritoneal Neoplasms/diagnosis , Peritoneal Neoplasms/genetics , Polymerase Chain Reaction
10.
EJHaem ; 1(2): 537-544, 2020 Nov.
Article in English | MEDLINE | ID: mdl-35845010

ABSTRACT

Objective: To examine the prevalence of hypogammaglobulinemia in chronic lymphocytic lymphoma (CLL) patients and to test the hypothesis that patients with hypogammaglobulinemia have a distinct clinical profile and outcome. Methods: Immunoglobulin levels (IgA, IgG, IgM, IgE) were measured in newly diagnosed, treatment naïve banked samples of 150 patients with CLL followed prospectively for outcomes. Cox regression models were used to assess the effects of clinical variables on overall survival (OS). Results: The median age of the selected CLL cohort was 64 years with a male predominance; 96.2% of the patients were white. Fifty-nine deaths occurred during a median follow up of 6.8 years. Hypogammaglobulinemia in CLL was common in our cohort with 88 (58.7%, 95% CI: 50.4-66.6%) patients having a measurable isotype deficiency. The most common Ig deficiency was IgM (44.0%). IgA deficiency or low IgE was associated with higher Rai stages as well as with higher white blood cell counts at presentation. Any immunoglobulin deficiency was not associated with overall survival. Conclusion: A significant proportion of treatment-naïve CLL patients had underlying Ig deficiencies - both in isolation and in isotype combinations. Although a deficiency of IgA or IgE was associated with more severe disease at presentation, the impact of this association was mild.

11.
PLoS One ; 14(12): e0226200, 2019.
Article in English | MEDLINE | ID: mdl-31869355

ABSTRACT

OBJECTIVE: Medium chain triglycerides (MCT) have unique metabolic properties which may improve insulin sensitivity (Si) and beta cell function but data in humans are limited. We conducted a 6-week clinical trial of MCT oil supplementation. METHODS: 22 subjects without diabetes (8 males, 14 females, mean ± standard error age 39±2.9 years, baseline BMI 27.0±1.4 kg/m2) were counseled to maintain their body weight and physical activity (PA) during the trial. Dietary intake, PA data, body composition, and resting energy expenditure (REE) were obtained through dietary recall, international PA questionnaire, dual x-ray absorptiometry, and indirect calorimetry, respectively. MCT prescriptions were given based on REE and PA to replace part of dietary fat with 30 grams of MCT per 2000 kcal daily. Insulin-modified frequently sampled intravenous glucose tolerance tests were performed before and after MCT to measure changes in Si, acute insulin response (AIR), disposition index (DI), and glucose effectiveness (Sg). RESULTS: MCT were well tolerated and weight remained stable (mean change 0.3 kg, p = 0.39). Fasting REE, respiratory quotient, and body composition were stable during the intervention. There were no significant changes in mean fasting glucose, insulin, insulin resistance, fasting total ketones, Si, AIR, DI, Sg, leptin, fructosamine, and proinsulin. The mean change in Si was 0.5 10-4 min-1 per mU/L (95% CI: -1.4, 2.4), corresponding to a 12% increase from baseline, and the range was -4.7 to 12.9 10-4 min-1 per mU/L. Mean total adiponectin decreased significantly from 22925 ng/mL at baseline to 17598 ng/mL at final visit (p = 0.02). The baseline clinical and laboratory parameters were not significantly associated with the change in Si. DISCUSSION: There were a wide range of changes in the minimal model parameters of glucose and insulin metabolism in subjects following 6 weeks of MCT as an isocaloric substitution for part of usual dietary fat intake. Since this was a single-arm non-randomized study without a control group, it cannot be certain whether these changes were due to MCT so further randomized controlled trials are warranted.


Subject(s)
Dietary Fats/administration & dosage , Dietary Supplements , Insulin Resistance , Insulin-Secreting Cells/drug effects , Obesity/diet therapy , Triglycerides/administration & dosage , Adipokines/blood , Adult , Body Composition/drug effects , Feasibility Studies , Female , Glucose Tolerance Test , Humans , Insulin/metabolism , Insulin-Secreting Cells/physiology , Male , Obesity/metabolism , Obesity/physiopathology , Pilot Projects
12.
Obes Surg ; 29(5): 1624-1631, 2019 05.
Article in English | MEDLINE | ID: mdl-30796614

ABSTRACT

BACKGROUND: Weight loss surgery (WLS) is neither risk-free nor universally effective. Few studies have examined what proportion of patients regret having undergone WLS. METHODS: We interviewed patients at two WLS centers before and after WLS about weight loss, quality of life/QOL (Impact of Weight on QOL-lite), and decision regret (modified Brehaut Regret scale, range 0-100). We conducted separate multivariable logistic regression models to examine the association between weight loss and ∆QOL scores and having decision regret (score > 50). RESULTS: Of 205 RYGB patients, only 2.2% (year 1) to 5.1% (year 4, n = 134) reported regret scores > 50 over 4 years; 2.0-4.5% did not think they made the right decision; 2.0-4.5% would not undergo WLS again. In contrast, of 188 gastric banding patients (n = 123 at year 4), 8.2-20.3% had regret scores > 50; 5.9-19.5% did not think they made the right decision; 7.1-19.5% would not undergo WLS again. Weight loss and ∆QOL scores were significant correlates of decision regret after banding although weight loss was a stronger correlate with lower model quasi-likelihood under the independence model criterion score. Four years after banding, mean weight loss for patients with regret scores > 50 was 7.4% vs. 21.1% for those with scores < 50; the AOR for regret score > 50 was 0.90 (95% CI 0.87-0.94) for every 1% greater weight loss. Poor sexual function, but not weight loss or other QOL factors, was significantly correlated with decision regret after RYGB. CONCLUSION: Few patients regret undergoing RYGB but 20% regret undergoing gastric banding with weight loss being a major driver.


Subject(s)
Decision Making , Emotions , Gastric Bypass , Gastroplasty , Adult , Cohort Studies , Female , Humans , Interviews as Topic , Longitudinal Studies , Male , Middle Aged , Quality of Life , Sexual Dysfunction, Physiological/complications , Sexual Dysfunctions, Psychological/complications , Weight Loss
13.
Prev Chronic Dis ; 15: E77, 2018 06 14.
Article in English | MEDLINE | ID: mdl-29908054

ABSTRACT

We aimed to test the feasibility of an in-person behavioral weight-loss intervention for underserved postpartum African American women with overweight or obesity in an urban hospital setting. Participants were randomized to an intervention of a culturally tailored adaptation of the Diabetes Prevention Program or usual care. The primary outcome was program satisfaction. Women who completed the intervention reported higher levels of satisfaction with the program, despite low attendance rates at group meetings. The intervention was not feasible because of these low rates of attendance and high rates of attrition after randomization. Offering the program electronically and off-site for convenience and more psychosocial support for postpartum women with obesity may improve feasibility.


Subject(s)
Behavior Therapy , Black or African American , Obesity/prevention & control , Postpartum Period , Vulnerable Populations , Adult , Female , Humans , Young Adult
14.
Front Pediatr ; 6: 101, 2018.
Article in English | MEDLINE | ID: mdl-29707530

ABSTRACT

OBJECTIVES: Disparities in obesity care exist among African-American children and adults. We sought to test the feasibility of a pilot program, a 1-year family-based intervention for African-American families with obesity [shape up and eat right (SUPER)], adopting the shared medical appointment model (SMA) at an urban safety net hospital. OUTCOMES: Primary outcomes: (1) family attendance rate and (2) program satisfaction. Secondary outcomes: change in body mass index (BMI), eating behaviors, and sedentary activity. METHODS: Adult parents (BMI ≥ 25 kg/m2) ≥18 years and their child(ren) (BMI ≥ 85th percentile) ages 6-12 years from adult or pediatric weight management clinics were recruited. One group visit per month (n = 12) consisting of a nutrition and exercise component was led by a nurse practitioner and registered dietitian. Height and weight were recorded during each visit. Participants were queried on program satisfaction, food logs and exercise journals, Food Stamp Program's Food Behavior, and the Expanded Food and Nutrition Education Program food checklists. RESULTS: Thirteen participants from lower socioeconomic zip codes consented [n = 5 mothers mean age 33 years, BMI of 47.4 kg/m2 (31.4-73.6 kg/m2); n = 8 children; mean age 9 years, BMI of 97.6th percentile (94-99th percentile); 60% enrolled in state Medicaid]. Average individual attendance was 23.4% (14-43%; n = 13); monthly session attendance rates declined from 100 to 40% by program completion; two families completed the program in entirety. Program was rated (n = 5 adults) very satisfactory (40%) and extremely satisfactory (60%). Pre-intervention, families rated their eating habits as fair and reported consuming sugar-sweetened beverages or sports drinks, more so than watching more than 1 h of television (p < 0.002) or video game/computer activity (p < 0.006) and consuming carbonated sodas (p < 0.004). Post-intervention, reducing salt intake was the only statistically significant variable (p < 0.029), while children watched fewer hours of television and spent less time playing video games (from average 2 to 3 h daily; p < 0.03). CONCLUSION: Attendance was lower than expected though children seemed to decrease screen time and the program was rated satisfactory. Reported socioeconomic barriers precluded families from attending most sessions. Future reiterations of the intervention could be enhanced with community engagement strategies to increase participant retention.

15.
JAMA Intern Med ; 178(4): 530-541, 2018 04 01.
Article in English | MEDLINE | ID: mdl-29532075

ABSTRACT

Importance: The Institute of Medicine set the recommended dietary allowance (RDA) for protein at 0.8 g/kg/d for the entire adult population. It remains controversial whether protein intake greater than the RDA is needed to maintain protein anabolism in older adults. Objective: To investigate whether increasing protein intake to 1.3 g/kg/d in older adults with physical function limitations and usual protein intake within the RDA improves lean body mass (LBM), muscle performance, physical function, fatigue, and well-being and augments LBM response to a muscle anabolic drug. Design, Setting, and Participants: This randomized clinical trial with a 2 × 2 factorial design was conducted in a research center. A modified intent-to-treat analytic strategy was used. Participants were 92 functionally limited men 65 years or older with usual protein intake less thanor equal to 0.83 g/kg/d within the RDA. The first participant was randomized on September 21, 2011, and the last participant completed the study on January 19, 2017. Interventions: Participants were randomized for 6 months to controlled diets with 0.8 g/kg/d of protein plus placebo, 1.3 g/kg/d of protein plus placebo, 0.8 g/kg/d of protein plus testosterone enanthate (100 mg weekly), or 1.3 g/kg/d of protein plus testosterone. Prespecified energy and protein contents were provided through custom-prepared meals and supplements. Main Outcomes and Measures: The primary outcome was change in LBM. Secondary outcomes were muscle strength, power, physical function, health-related quality of life, fatigue, affect balance, and well-being. Results: Among 92 men (mean [SD] age, 73.0 [5.8] years), the 4 study groups did not differ in baseline characteristics. Changes from baseline in LBM (0.31 kg; 95% CI, -0.46 to 1.08 kg; P = .43) and appendicular (0.04 kg; 95% CI, -0.48 to 0.55 kg; P = .89) and trunk (0.24 kg; 95% CI, -0.17 to 0.66 kg; P = .24) lean mass, as well as muscle strength and power, walking speed and stair-climbing power, health-related quality of life, fatigue, and well-being, did not differ between men assigned to 0.8 vs 1.3 g/kg/d of protein regardless of whether they received testosterone or placebo. Fat mass decreased in participants given higher protein but did not change in those given the RDA: between-group differences were significant (difference, -1.12 kg; 95% CI, -2.04 to -0.21; P = .02). Conclusions and Relevance: Protein intake exceeding the RDA did not increase LBM, muscle performance, physical function, or well-being measures or augment anabolic response to testosterone in older men with physical function limitations whose usual protein intakes were within the RDA. The RDA for protein is sufficient to maintain LBM, and protein intake exceeding the RDA does not promote LBM accretion or augment anabolic response to testosterone. Trial Registration: clinicaltrials.gov Identifier: NCT01275365.


Subject(s)
Activities of Daily Living , Body Composition , Dietary Proteins/administration & dosage , Health Status , Mental Health , Muscle Strength , Quality of Life , Absorptiometry, Photon , Affect , Aged , Aged, 80 and over , Androgens/therapeutic use , Double-Blind Method , Fatigue , Humans , Independent Living , Male , Recommended Dietary Allowances , Testosterone/analogs & derivatives , Testosterone/therapeutic use
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