Protein Recommendation to Increase Muscle (PRIMe): Study protocol for a randomized controlled pilot trial investigating the feasibility of a high protein diet to halt loss of muscle mass in patients with colorectal cancer.

BACKGROUND: Severe muscle mass (MM) loss is a defining feature of cancer observed across all types and stages of disease and is an independent predictor of poor clinical outcomes including higher incidences of chemotherapy toxicity and decreased survival. Protein is essential to build MM, yet the optimal amount for preventing or treating muscle loss in patients with cancer remains undefined. METHODS: The Protein Recommendation to Increase Muscle (PRIMe) study is a single-center, two-armed, parallel, randomized, controlled pilot trial that assesses the feasibility of utilizing a high protein (HP) diet to positively impact clinical outcomes in people undergoing chemotherapy to treat colorectal cancer. Forty patients with newly diagnosed stage II-IV colorectal cancer who are scheduled to receive chemotherapy will be included. Participants are randomly assigned to a HP or normal protein (NP) diet for twelve weeks. The HP and NP groups receive nutrition recommendations to achieve 2.0 g of protein per kilogram of body weight per day (g∙kg-1∙d-1) and 1.0 g⋅kg-1⋅d-1, respectively. These values refer to the upper and lower recommended range of protein intake for people with cancer. Energy recommendations are based on measured energy expenditure. Assessments are completed within two weeks of starting chemotherapy (baseline), at week 6, and at week 12. Changes to skeletal MM, physical function, anthropometrics, body composition, muscle strength, physical activity, energy metabolism, metabolic markers, nutritional status, quality of life, readiness to change and psychosocial determinants of behavioural change are assessed between the HP and NP groups. Feasibility of the nutritional intervention is assessed by change in MM as a surrogate marker. CONCLUSIONS: This evidence-based study investigates the feasibility of increasing protein intake following a diagnosis of cancer on clinical outcomes during treatment for colorectal cancer. This study will inform larger trials assessing the impact of increasing protein intake in cancer to determine their importance and integration into standard clinical care for people with cancer.

Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity.

Both aging and obesity are associated with increased levels of pro-inflammatory metabolites, while weight reduction is associated with improvements in inflammatory status. However, few studies have explored the response of key inflammatory markers to the combined settings of weight reduction in an aging population. There are also few studies that have investigated the potential impact of diet composition on inflammatory marker responses. In the MEASUR-UP trial, we evaluated changes in baseline levels of inflammatory markers with post-study levels for a traditional weight loss control group versus a group with generous, balanced protein intake. In this 6-month randomized controlled trial (RCT), older (≥60 years) adults with obesity (BMI ≥30 kg/m2) and Short Physical Performance Battery (SPPB) score of 4-10 were randomly assigned to either a traditional weight loss regimen, (Control, n = 14) or one with higher protein intake (≥30 g) at each meal (Protein, n = 25). All participants were prescribed a hypo-caloric diet and attended weekly support and education groups and weigh-ins. Protein participants consumed ≥30 g of high-quality protein/meal, including lean and extra lean beef provided to them for two of the three meals per day. Protein intakes were 0.8 and 1.2 g/kg/day for Control and Protein, respectively. Adiponectin, leptin, C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), IL-6, IL-8, serum amyloid A (SAA), vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1), and glycated serum protein (GSP) levels were measured at 0 and 6-month time points. At the 6-month endpoint, there was significant weight loss and decrease in BMI in both the Control (-4.8 ± 8.2 kg; -2.3 ± 2.4 kg/m2; p = 0.05) and Protein (-8.7 ± 7.4 kg; -2.9 ± 2.3 kg/m2; p < 0.0001) groups. SPPB scores improved in both arms, with a superior functional response in Protein (p < 0.05). Body fat (%) at baseline was positively correlated with leptin, hs-CRP, VCAM-1, ICAM-1, and GSP. Several markers of inflammation responded to the Protein group: leptin (p < 0.001), hs-CRP (p < 0.01), and ICAM-1 (p < 0.01) were decreased and adiponectin increased (p < 0.01). There were no significant changes in any inflammatory markers in the Control arm. In the between group comparison, only adiponectin trended towards a group difference (more improvement in Protein; p < 0.07). Our findings in the MEASUR-UP trial show that a weight loss diet with enhanced protein intake is comparable to an adequate protein diet in terms of weight loss success and that it can lead to improvements in inflammatory status, specifically for adiponectin, leptin, hs-CRP, and ICAM-1. These findings are important given current recommendations for higher protein intakes in older adults and justify the additional study of the inflammatory impact of an enhanced protein diet. (ClinicalTrials.gov identifier: NCT01715753).

Challenges in the Management of Geriatric Obesity in High Risk Populations.

The global prevalence of obesity in the older adult population is growing, an increasing concern in both the developed and developing countries of the world. The study of geriatric obesity and its management is a relatively new area of research, especially pertaining to those with elevated health risks. This review characterizes the state of science for this "fat and frail" population and identifies the many gaps in knowledge where future study is urgently needed. In community dwelling older adults, opportunities to improve both body weight and nutritional status are hampered by inadequate programs to identify and treat obesity, but where support programs exist, there are proven benefits. Nutritional status of the hospitalized older adult should be optimized to overcome the stressors of chronic disease, acute illness, and/or surgery. The least restrictive diets tailored to individual preferences while meeting each patient's nutritional needs will facilitate the energy required for mobility, respiratory sufficiency, immunocompentence, and wound healing. Complications of care due to obesity in the nursing home setting, especially in those with advanced physical and mental disabilities, are becoming more ubiquitous; in almost all of these situations, weight stability is advocated, as some evidence links weight loss with increased mortality. High quality interdisciplinary studies in a variety of settings are needed to identify standards of care and effective treatments for the most vulnerable obese older adults.

The need to advance nutrition education in the training of health care professionals and recommended research to evaluate implementation and effectiveness.

Nutrition is a recognized determinant in 3 (ie, diseases of the heart, malignant neoplasms, cerebrovascular diseases) of the top 4 leading causes of death in the United States. However, many health care providers are not adequately trained to address lifestyle recommendations that include nutrition and physical activity behaviors in a manner that could mitigate disease development or progression. This contributes to a compelling need to markedly improve nutrition education for health care professionals and to establish curricular standards and requisite nutrition and physical activity competencies in the education, training, and continuing education for health care professionals. This article reports the present status of nutrition and physical activity education for health care professionals, evaluates the current pedagogic models, and underscores the urgent need to realign and synergize these models to reflect evidence-based and outcomes-focused education.

Nutrition education in medical school: a time of opportunity.

Undergraduate medical education has undergone significant changes in development of new curricula, new pedagogies, and new forms of assessment since the Nutrition Academic Award was launched more than a decade ago. With an emphasis on a competency-based curriculum, integrated learning, longitudinal clinical experiences, and implementation of new technology, nutrition educators have an opportunity to introduce nutrition and diet behavior-related learning experiences across the continuum of medical education. Innovative learning opportunities include bridging personal health and nutrition to community, public, and global health concerns; integrating nutrition into lifestyle medicine training; and using nutrition as a model for teaching the continuum of care and promoting interprofessional team-based care. Faculty development and identification of leaders to serve as champions for nutrition education continue to be a challenge.

Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: results from NAVIGATOR.

OBJECTIVE: The cardiometabolic risk cluster metabolic syndrome (MS) includes ≥3 of elevated fasting glucose, hypertension, elevated triglycerides, reduced high-density lipoprotein cholesterol (HDL-c), and increased waist circumference. Each can be affected by physical activity and diet. Our objective was to determine whether determine whether baseline physical activity and/or diet behavior impact MS in the course of a large pharmaceutical trial. MATERIALS/METHODS: This was an observational study from NAVIGATOR, a double-blind, randomized (nateglinide, valsartan, both, or placebo), controlled trial between 2002 and 2004. We studied data from persons (n=9306) with impaired glucose tolerance and cardiovascular disease (CVD) or CVD risk factors; 7118 with pedometer data were included in this analysis. Physical activity was assessed with 7-day pedometer records; diet behavior was self-reported on a 6-item survey. An MS score (MSSc) was calculated using the sum of each MS component, centered around the Adult Treatment Panel III threshold, and standardized according to sample standard deviation. Excepting HDL-c, assessed at baseline and year 3, MS components were assessed yearly. Follow-up averaged 6 years. RESULTS: For every 2000-step increase in average daily steps, there was an associated reduction in average MSSc of 0.29 (95% CI (-)0.33 to (-)0.25). For each diet behavior endorsed, there was an associated reduction in average MSSc of 0.05 (95% CI (-)0.08 to (-)0.01). Accounting for the effects of pedometer steps and diet behavior together had minimal impact on parameter estimates with no significant interaction. Relations were independent of age, sex, race, region, smoking, family history of diabetes, and use of nateglinide, valsartan, aspirin, antihypertensive, and lipid-lowering agent. CONCLUSIONS: Baseline physical activity and diet behavior were associated independently with reductions in MSSc such that increased attention to these lifestyle elements provides cardiometabolic benefits. Thus, given the potential to impact outcomes, assessment of physical activity and diet should be performed in pharmacologic trials targeting cardiometabolic risk.

Nutritional supplements for older adults: review and recommendations--Part II.

The use of nutritional supplements (NS) with the intention of improving health and delaying age-related chronic disease is a common practice among older adults; however, randomized controlled trials have yielded mixed results regarding the likelihood that these NS provide true health benefits. We reviewed the findings of these studies regarding the effects of NS of folic acid, vitamin B(12), vitamin B(6), and omega-3 fatty acids on health outcomes in older adults. Our conclusions include the following: Supplements of the B vitamins folate, B(12) and B(6) have been studied with regards to primary and secondary prevention of a number of major age-related chronic diseases, including cardiovascular disease (CVD), stroke, cognitive decline, and cancer. While there are some encouraging findings with regards to stroke, depression, and macular degeneration (although in only one study in the latter case), there is little evidence of benefit of B vitamin NS for delaying CVD or age-related cognitive changes. In the few cancer-related studies, the evidence of benefit is coupled with concerns about enhancing the growth of existing undiagnosed cancers. In contrast, clear health benefits have been shown with modest increases in consumption of fatty fish or fish oil supplements, including a reduction in the risk of sudden cardiac death. In addition, there is evidence that high dose fish oil supplements may lower serum triglyceride levels.

Nutritional supplements for older adults: review and recommendations-part I.

The majority of older adults take nutritional supplements (NS) to prevent deficiencies and/or because they are interested in the potential health promoting effects of these nutrients. This review explores the evidence of benefit for supplements of multivitamin/minerals (MVM), antioxidant nutrients, and vitamin D/calcium. Major conclusions include the following: While recommendations that older adults take a daily MVM are common, there is limited scientific support for the health-related efficacy of these supplements. In contrast, a number of antioxidant nutrients have been extensively studied. The evidence does not support a recommendation for vitamins A, C, E, or antioxidant combinations in the prevention of CVD or cancer. Based on encouraging preliminary findings, more study is recommended on the benefit of antioxidant supplements for age-related macular degeneration and of selenium for cancer prevention. In contrast to the state of the art for antioxidant supplements, there is strong and compelling support for the health benefits of supplements of Vitamin D and calcium when intake/status of these nutrients is not optimal. Thus, specific recommendations for these supplements in older adults are warranted.