Excess adipose tissue and sarcopenia promotes a unique multifaceted challenge that may exacerbate the risk of morbidity and mortality in the obese, elderly population. We have demonstrated the effectiveness of essential amino acids in stimulating muscle protein synthesis under a variety of physiological scenarios, even under conditions of additional metabolic stress. Due to limited application of these strategies in our studies, we have developed a product uniquely suited to address muscle wasting during weight loss, and based our development on the criteria of taste, volume, price and packaging. Based on the unique formulation of ingredients, we have chosen to market the product under the brand name BeneVia(R) Weight Loss. While the development of BeneVia(R) Weight Loss is based upon theoretical and scientific rationale, the actual product has not been tested in a clinical scenario. Thus, the goal of this Phase 1 application will be to determine if the of BeneVia(R) Weight Loss stimulates muscle protein synthesis and maintains muscle mass more effectively than currently available products for obese, elderly individuals. If the results of the Phase 1 test are positive, the Phase 2 study will be a double-blind placebo outcome trial comparing BeneVia(R) Weight Loss with a popular nutritional supplement. In this way, we can determine the efficacy of the products towards optimal reduction of adipose tissue and the adequate maintenance of muscle mass. We will also utilize stable isotope methodology to quantify muscle protein synthesis and relate acute supplement-induced changes in metabolism to long-term outcome based parameters.
Public Health Relevance: This proposal describes a nutritional supplement designed to maintain muscle mass, even under the metabolic challenge of caloric restriction-induced weight loss in obese, elderly individuals. If successful, the result is an economical nutritional product that can be utilized to attenuate morbidity and mortality with aging. This will not only improve quality of life in elderly, but have a significant impact on overall health care costs.
Public Health Relevance Statement: 7. Project Narrative This proposal describes a nutritional supplement designed to maintain muscle mass, even under the metabolic challenge of caloric restriction-induced weight loss in obese, elderly individuals. If successful, the result is an economical nutritional product that can be utilized to attenuate morbidity and mortality with aging. This will not only improve quality of life in elderly, but have a significant impact on overall health care costs.
Project Terms: 21+ years old; Acceleration; Activities of Daily Living; Activities of everyday life; Acute; Address; Adipose tissue; Adult; Aged 65 and Over; Aging; Aging Process; Aging-Related Process; Amino Acids; Amino Acids, Essential; Attenuated; Body Composition; Body Tissues; Body Weight decreased; Caloric Intake; Caloric Restriction; Causality; Chronic; Clinical; Clinical Trials, Phase II; Consumption; Development; Diet; Diet Supplement; Dietary Proteins; Dietary Supplements; Dose; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Drug Formulations; Effectiveness; Elderly; Elderly, over 65; Energy Intake; Essential Amino Acids; Etiology; Fatty Tissue; Formulation; Formulations, Drug; Goals; Gustation; Health; Health Care Costs; Health Costs; Healthcare Costs; Human, Adult; INFLM; Individual; Inflammation; Intake; Intermediary Metabolism; Link; METBL; Macronutrients; Macronutrients Nutrition; Maintenance; Maintenances; Marketing; Measurable; Measures; Metabolic; Metabolic Control; Metabolic Processes; Metabolic stress; Metabolic syndrome; Metabolism; Method LOINC Axis 6; Methodology; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Muscle; Muscle Proteins; Muscle Tissue; Muscle, Skeletal; Muscle, Voluntary; Names; Nutrition; Nutrition, Macronutrients; Nutritional; Nutritional Science; Nutritional Supplement; Obesity; Outcome; PBO; Peptide Biosynthesis, Ribosomal; Phase; Phase 2 Clinical Trials; Phase II Clinical Trials; Physiologic; Physiological; Placebos; Population; Prevalence; Price; Protein Biosynthesis; Protein Biosynthesis, Ribosomal; Protein Synthesis, Ribosomal; Proteins; QOL; Quality of life; Recommended Daily Allowances; Risk; Science of nutrition; Senescence; Sham Treatment; Skeletal Muscle Tissue; Skeletal muscle structure; Supplementation; Taste; Taste Perception; Testing; Tissues; Weight Loss; Weight Reduction; adipose; adiposity; adult human (21+); advanced age; aging population; aminoacid; base; body weight loss; caloric dietary content; calorie restriction; corpulence; corpulency; corpulentia; daily living functionality; design; designing; disease causation; disease etiology; disease/disorder etiology; disorder etiology; elders; essential amino acid; essential aminoacid; experience; feeding; frailty; functional ability; functional capacity; gene product; geriatric; improved; late life; later life; muscle form; muscle metabolism; nutrient recommended daily allowance; nutrition; obese; obese people; obese person; obese population; obesity treatment; older adult; older person; phase 2 study; phase 2 trial; phase II trial; pricing; protein synthesis; protocol, phase II; public health relevance; response; sarcopenia; senescent; senior citizen; sham therapy; stable isotope; study, phase II; trial comparing; volunteer; wasting; white adipose tissue; wt-loss; yellow adipose tissue
