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Appendix C

Letter Report: Research Progress Review of the Pennington Biomedical Research Center

Submitted May 1992



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Committee on Military Nutrition Research: Activity Report Appendix C Letter Report: Research Progress Review of the Pennington Biomedical Research Center Submitted May 1992

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Committee on Military Nutrition Research: Activity Report This page in the original is blank.

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Committee on Military Nutrition Research: Activity Report INSTITUTE OF MEDICINE NATIONAL ACADEMY OF SCIENCES 2101 CONSTITUTION AVENUE WASHINGTON, D.C. 20418 FOOD AND NUTRITION BOARD (202) 334-1732 FAX (202) 334-2316May 15, 1992 Major General Richard T. Travis Commanding General U.S. Army Medical Research and Development Command Fort Detrick Frederick, MD21702-5012 Dear General Travis: At the specific request of the COL Eldon W. Askew, Ph.D., Chief, Military Nutrition Division, U.S. Army Research Institute of Environmental Medicine (USARIEM) who is Grant Officer Representative of the US Army Medical Research and Development Command (USAMRDC) for Grant no. DAMD17-86-G-6036 to the National Academy of Sciences for support of the Food and Nutrition Board's (FNB) Committee on Military Nutrition Research (CMNR), the CMNR met at the Pennington Biomedical Research Center in Baton Rouge, Louisiana on Sept. 19-20, 1991. The purpose of this meeting was to assist the Army in reviewing and evaluating the progress on work related to the USAMRDC Grant no. 17-88-Z-8023: “Effect of Food, Diet, and Nutrition on Military Readiness and Preparedness of Army Personnel and Dependents in a Peacetime Environment”. This Grant was established to implement this program for which funds were specifically allocated through the House Authorization Committee (DOD Appropriations Bill, 1988). An important consideration in the initiation of the Army funded program was that these funds were allocated for a 3 year period and the Pennington Center was not yet staffed or equipped. Initial proposals for one of these funds were developed by Louisiana State University (LSU) largely drawing on the interests and personnel available from the LSU Medical Center. As discussed in the letter report dated June 26, 1989, to Major General Philip K. Russell (see attachments), the Committee reviewed these proposals

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Committee on Military Nutrition Research: Activity Report which were quite preliminary in nature. The proposal by Dr. Gerald Berenson came closest to meeting the criteria established in the Appropriations Bill. The Committee also recognized the value of establishing a research laboratory which could provide analytical support to the nutritional assessment program conducted by the Nutrition Research Group at Natick Laboratories. The Committee on Military Nutrition Research's role in this preliminary review was to assist the Army with identifying research activities that fell within the mandate of the appropriation with the responsibility for the final decisions in program and funding with the Army. Prior to assembling at the Pennington Biomedical Research Center, the CMNR reviewed: 1) an information paper and background materials, including the Grant Statement of Work, provided by COL Askew, the Grant Officer Representative; 2) the Final Report on USAMRDC Grant to the Pennington Center submitted by the principal investigator, Donna H. Ryan, M.D.; and 3) an earlier report prepared by the CMNR at the request of the USAMRDC reviewing this same research program in 1989. Copies of the information papers, the 1989 report from the CMNR, plus the meeting agenda and list of participants are attached. On September 19, 1991 the CMNR convened at the Pennington Biomedical Research Center (PBRC) and heard presentations of the research accomplishments during the grant period from the Center staff and a statement from COL Askew. On September 20, 1991 the Committee met in executive session and reviewed the accomplishments of the Pennington Biomedical Research Center over the grant period in relation to the grant Statement of Work, the goals of the principal investigator, and their own previous recommendations. To provide supplemental expertise to the Committee membership in the area of neurotransmitters, the CMNR also submitted a copy of that part of the annual report of the Pennington Biomedical Research Center grant dealing with Project No. 3, Diet, Neurotransmitters, and Behavior, to two scientists currently working in this research area for confidential review. The Committee included the review of this outside team in their deliberations when writing this report. All CMNR members present at the meeting have seen and approved the report. Subsequent to approval of the final draft by the Committee, in accordance with National Research Council guidelines, this report was reviewed in confidence by a separate anonymous scientific review group. The Committee and advisors have reviewed the anonymous comments of this review panel and incorporated their suggestions where appropriate. Staff has then written a letter of response to the reviewers with the final report draft and obtained final approval of the report from the review panel. This report is

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Committee on Military Nutrition Research: Activity Report thus a thoughtfully developed presentation that incorporates the scientific opinion of the CMNR, and the anonymous National Research Council reviewers. Following is the Committee on Military Nutrition's evaluation of the research program presented to them and to Army personnel at the Pennington Biomedical Research Center. General Comments The Pennington Biomedical Research Center is a very impressive facility having an excellent physical plant for laboratory and clinical research. Considerable progress has been achieved in staffing and development of research activities since the CMNR's last visit on December 12, 1988. This has been made possible by financial support from the U.S. Army, USDA, and grants from NIH and other sources. In addition, the state of Louisiana has provided ongoing support at a level of $4.1 million dollars. It is worthy of note that the new director for the PBRC, George A. Bray, M.D., has been appointed since the Committee's last visit. Dr. Bray, who is internationally renowned for his research in the fields of obesity and energy metabolism, has provided an important vision for the Pennington Center (which he is moving rapidly to bring to fruition). The progress noted builds effectively on the initial framework established by Dr. Allen Copping, President of the Louisiana State University (LSU) system, and on the ongoing administrative support of Donna H. Ryan, M.D., Project Director for the Military Nutrition Grant. In general the Committee found that there was effective management support and guidance for the development of activities related to this grant. The progress in each project area was reviewed by the Committee and its assessment follows. Specific Project Reviews Project No. 1: Clinical Research Lab. This project is headed by Richard Tully, Ph.D. The major objective of this project was to provide biochemical assessment of nutrition status and to perform food biochemistry analysis. Significant progress has been made in securing necessary analytical equipment, implementing appropriate analytical procedures and most

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Committee on Military Nutrition Research: Activity Report importantly, in implementing a sound quality assurance program. Dr. Tully has made significant progress in activating an effective clinical laboratory in a short period of time and in utilizing this facility to support requests from USARIEM. It should be noted that all of this has been accomplished with limited staff support. The Committee is of the opinion that the Clinical Research Lab is a valuable resource to the Pennington Biomedical Research Center as well as being extremely valuable to USARIEM. The nutrition group at USARIEM has previously experienced difficulty in obtaining accurate and timely analytical information from outside contract laboratories. The ability to obtain important analytical data on military nutrition research projects in a timely manner greatly enhances the effectiveness of the nutrition research program. We recommend that the U.S. Army continue to provide partial support for this activity with the understanding that this resource be available on a priority basis to support U.S. Army studies. Further, the Committee supports the provision of additional resources to increase staffing of the Clinical Research Lab. The staff of the Pennington Center has indicated a desire to develop a food analysis capability. The Committee recognizes the need for food analysis to support the clinical studies which the Center anticipates undertaking. In order to develop this capability effectively it is important to add an experienced food chemist to the Pennington Center staff. A major food analysis program would consume considerable resources both for methods development and actual analysis of various food components. Further, the undertaking of food analysis will require significant equipment additions and the staff should make judicious decisions regarding what analyses need to be performed beyond proximate analysis and inorganic elements. The CMNR believes that the breadth of activity necessary to establish a high quality food analysis laboratory would involve significantly more expertise, resources (equipment, personnel, and supplies), and facilities than is currently projected at the Pennington Biomedical Research Center. The Committee therefore holds that limited analysis on foods, related specifically to electrolyte balance, may be more within the scope of the laboratory's capabilities. Project No. 2: Stable Isotope Lab. This project is directed by James P. DeLany, Ph.D. who has a good background in the use of stable isotopes to measure energy expenditure and body composition. The stable isotope technique provides a unique approach for use in free-living subjects since it is non-invasive and nondestructive. Consequently, it provides an ideal means of assessing important endpoints in experimentation valuable to the military.

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Committee on Military Nutrition Research: Activity Report The equipment that has been purchased and installed is state-of-the-art allowing Dr. DeLany to establish his methods and rapidly gear up his laboratory to support multiple studies. The Committee was favorably impressed with the quality and quantity of work completed thus far. In view of the expanding nature of military research projects which utilize stable isotopes in their protocols, the Committee recommends continued funding of the Stable Isotope Laboratory for priority support of military studies. The staff of the Pennington Center have indicated a desire to increase the staffing of the laboratory by one additional Ph.D. scientist. In view of the importance of this methodology, the Committee would encourage such an addition if possible. The availability of stable isotopes required for this work is currently limited and could curtail the ability to adequately support this area of research by the military as well as other investigations. The CMNR recommends that the military encourage the development of an adequate supply of the necessary stable isotope through combined efforts of the federal research establishment. Project No. 3: Diet, Neurotransmitters and Behavior. This project is directed by Chandon Prasad, Ph.D. and has been staffed during the project period with five additional scientists on full or part time basis. In addition nine students have participated part time over the project period. The efforts to date have been devoted to developing the methodology for studying the effect of diet on behavior in animal models. The CMNR believes that the area of nutrition and behavior is of military relevance, but the current research effort lacks focus and appears to have limited applicability to military concerns. The Committee is of the opinion that there is a need to further explore appropriate, relevant areas of research at the physiological and cellular level that are pertinent to military applications. This would require a reorientation of the current effort with considerably greater focus. It is suggested that the researchers develop more specific hypotheses which then can be investigated to better target the projects and to better determine the relevance to the military. The Committee notes that 25 percent of the funding provided by the Army has been in support of the research program of Dr. Prasad. The military has a major interest in the potential influence of nutrition on behavior particularly in those areas that may improve or maintain cognitive performance under combat stress. With the increasing sophistication of weapons systems there is a need to increase the capability of the individual to maintain mental acuity to function with these systems.

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Committee on Military Nutrition Research: Activity Report The lack of focus can be illustrated by listing the titles of the 15 projects reviewed. These were: 1) Behavioral neurochemistry of food-derived peptides; 2) Cyclo (His-Pro) and food intake; 3) Determination of tryptophan metabolites using HPLC; 4) Preparation and characterization of dopamine (D2) receptor protein antibody; 5) Determination of dopamine (D2) receptor messenger RNA expression; 6) Dopamine (D2) receptor protein antibody mapping in the rat brain; 7) Dietary protein and behavior in rats; 8) Levels of dietary protein and modification of behavioral responses to CNS acting drugs; 9) Dietary protein and dopamine receptor regulation; 10) Effects of dietary protein on monoamines and monoamine metabolites; 11) Dietary protein and preparatory arousal in rats; 12) Dietary protein and neuronal plasticity; 13) Dietary protein and microtubule-associated proteins; 14) Dietary protein and brain amino acid profiles; and 15) Diet and stress. Many of the studies involved the effect of dietary protein in brain chemistry neuronal structure and behavior. Most of these studies involved feeding rats diets up to 50% protein. In view of the vast literature involving studies of dietary protein in brain development and behavior in rats, the value of still more rat studies to the military has not been justified. In particular, the use of diets supplying 50% casein is questionable and of little relevance to human feeding in or out of the military. Several of the projects appear to be “fishing expeditions”. It is important that the research conducted under this program be well focused in order that its relevance can be evaluated both in long term and in applications to the near term. The CMNR recommends that a special site review be conducted in which efforts are undertaken to delineate major Army needs and review the Pennington Biomedical Research Center's program in light of responding to those needs with highly focused research. It is recommended that the site review team be composed of individuals who work directly in the area of nutrition, cognition, and behavior with expertise in the field of neurotransmitters. Project No. 4: Fort Polk Study. The director of this study is Gerald S. Berenson, M.D. who initiated and developed the Bogalusa Heart Study. The project was completed in August 1991. The objective, as presented to the CMNR, was under the general title “Health Promotion Research and Assessment”, and is “Assessment of Nutritional Status and Cardiovascular Risk of Military Dependents.” While the Committee did not necessarily give this the highest priority rating in 1989, it was a project that could be implemented immediately. The study has achieved the objective of doing an nutritional/health risk appraisal of military dependents.

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Committee on Military Nutrition Research: Activity Report The second component of the Fort Polk Study was the development of a health promotion/education program for military families. It was unfortunate that the study did not have a larger sample size (n = 70 families) in the three cycles of families involved in the health promotion/education component. In addition, there was not a control group established for this component of the project. The CMNR also noted that the project report did not include any evaluation of the effectiveness of the program either on a short-term or long-term basis. For example, there was no measurement of changes from baseline measurements in behavior or other status indices. It is the understanding of CMNR that this project has been completed, and future funding is not planned under this program. The CMNR would concur with this position. In the event that future plans might evolve to include implementation of such a health promotion program for military dependents, it is the position of the CMNR that a thorough review of the results of this study and delineation of desired objectives, including inclusion of methodology to evaluate long-term outcomes, should be conducted prior to implementation. Project No. 5: U.S. Army Menu Modification Project. This project has been carried out by Evelina W. Cross, Ph.D. and Catherine Champagne, Ph.D. The results presented at the CMNR review were very preliminary, and the research team has been granted a no-cost extension to complete the requirements of the contract. It is the consensus of the CMNR that the investigators were not sensitive to the needs of military garrison feeding program as demonstrated by the preliminary menus provided at the review. The project did not demonstrate any application of menu planning guidelines that would be appropriate in the military menu system, in terms of cost, acceptability, color, etc. Their first phase of menu modification did not meet the objectives of the project; the second phase brought fat down from 40 to 36% (not 30%), but did not appreciably reduce sodium or cholesterol (except when substitutions were made for breakfast eggs). The menus developed initially decreased caloric intake from 3,500 to 3,030 kcal. This lowered caloric intake might be considered a problem in some garrison situations. The menus developed to date and presented to the CMNR did not address cost, appearance, national food preferences, or relevance to the military feeding system. The CMNR also questions whether the evaluation procedures used (college students consuming a meal as opposed to sensory evaluation panels, etc.) were applicable to the eventual user. Although, the project was incomplete when reviewed, the CMNR was not impressed with some of the

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Committee on Military Nutrition Research: Activity Report approaches taken. The Committee further viewed the lack of interaction between the menu developers and the military menu system as a serious constraint on the ability of the investigators to achieve their objectives. Therefore the Committee believes that this project, if continued, should be conducted in a military facility where the staff is more familiar with the military menu and procurement systems in order for a practical program to be developed. Overall Conclusions and Recommendations Generally, the Committee was impressed with the quality of the research activities at the Pennington Biomedical Research Center given the constraints of essentially starting from a zero base in equipping the facilities, recruiting staff, and initiating research activities, and felt that the funds provided by the U.S. Army grant had been effectively deployed. The CMNR would encourage continued financial support by the U.S. Army of those activities which have been and can continue to be relevant to the military namely the Clinical Research Laboratory and the stable isotope activity. Further, support of the area of nutrition and behavior should continue with attention to developing a project with greater focus and hence military relevance. Sincerely, Robert O. Nesheim, Ph.D. Chairman, Committee on Military Nutrition Research (CMNR) Enclosures cc: K. Shine C. Woteki D. Schnakenberg E. Askew B. Marriott