Essential Blends, LLC — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant The overall goal of this project is to test a meal replacement beverage that will ultimately preserve muscle loss during calorie restriction weight loss CRWL in obese older individuals We previously developed a meal replacement rich with a proprietary blend of essential amino acids TMR that was more than three times as effective as whey protein in stimulating muscle protein synthesis MPS in the elderly Utilizing this TMR and protein intake based on minimal protein requirements gm protein kg day we demonstrated a greater reduction in adipose tissue compared to a competitive meal replacement Even so volunteers still lost some muscle mass using the TMR This likely reflected the fact that the optimal protein intake in older individuals is significantly greater thn g kg day and the hypocaloric condition of CRWL further elevated the need for optimal protein In our formulation MyoEon we have now increased the absolute amount of EAAs and also included citrulline to even further promote the availability of EAAs to skeletal muscle Although MyoEon is sufficiently developed for testing the central hypothesis of this project part of this Phase project will be to further optimize several aspects of product The overarching hypothesis of this proposal is that the ingestion of MyoEon will foster an improvement in net protein synthesis through an increased rate of protein synthesis and a decreased rate of protein breakdown as compared to a commercially available andquot high proteinandquot meal replacement Bariatric Advantage Specific Aim We will optimize the palatability and cost for ingredients production packaging and fulfillment which will validate the hypothesis that MyoEon can be profitably sold in retail markets We will work directly with our food science partner Mattson Inc Foster City CA http www foodcom com to establish the criteria of acceptance for the formulation of MyoEon The metric of success will be defined by establishing the feasibility of MyoEon as a palatable determined by focus groups and cost effective total costs per product less than $ product for use in weight loss Specific Aim We will demonstrate the feasibility of MyoEon to preserve lean body mass during CRWL as compared to Bariatric Advantage through increased net protein synthesis calculated as the difference between protein synthesis and breakdown determined by stable isotope tracer methodology Demonstration that MyoEon is superior to the highest quality competitor will represent the metric of success for this aim and serve as the mechanistic underpinning for a Phase II randomized clinical trial RCT performed in conjunction with the Mountain West Clinical Translational Research Infrastructure Network In this RCT we will establish the effectiveness of MyoEon vs Bariatric Advantage in an outcome study focused on maintenance of muscle mass and improvement of functional capacity as well as amplification of the metabolic benefits of weight loss PUBLIC HEALTH RELEVANCE This study is designed to evaluate the impact of high density essential amino acids citrulline meal replacement MyoEon on the promotion of increased muscle protein synthesis relative to muscle protein breakdown as compared to Bariatric Advantage These data will then be utilized to derive the variability of the response to the meal replacement and will facilitate the accurate calculation of statistical power for multi site randomized clinical trial