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Pacific Northwest Laboratories Human Subjects Committee . The Measurement of Regional Muscle Mass Changes in Adult Human Volunteers by COUECTION mpeoldnerneb;ts Measuring Changes i n the Naturally BOXNo. 29 mOccurring 4 0 K This paper describes work t o be done for the NASA Johnson Space Center i n Houston, Texas, and involves human subjects. The work will be done under a currently existing contract and has been proposed under the condition t h a t i t will be done only if approved by the Battelle-Northwest Human Subjects Committee. The material below i s presented t o the Committee for review and approval. The work will begin imnediately upon receipt of t h i s approval. Need and Purpose of the Work Despite a rigorous exercise schedule, the astronauts i n the recent Skylab series space flights sustained muscle mass losses estimated body mass and has contracted with Battelle t o develop such methods. NASA needs methods t o evaluate changes i n lean NASA is more interested i n regional rather than total body measurechanges i n muscle mass which exceed 2% can be measured i n regions of the body such as upper legs, lower legs, shoulders, etc. by measuring the 40K content i n these regions. I t appears that this '+OK method will be more accurate t h a n other methods such as those requiring i n vivo neutron activation or injection of radioisotopes. I t has been shown i n numerous studies that 40K content i n humans and animals is directly proportional to lean body mass. In order t o demonstrate that this method is accurate enough for measuring muscle mass changes which may occur during space flight,it would be desirable t o periodically measure a few adult human volunteers who are on an exercise program which will build additional muscle mass i n the leg regions. Measurements could also be made on the volunteers a f t e r the exercise program is stopped and the loss of muscle mass would be analogous t o space flight losses. Justification for the Study Whole body counter measurements of 4 0 K typically have a standard deviation of 5%for repetitive measurements on the same person. I t appears that by using large NaI(Ta) detectors that
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111. Justification for the Study (contd.) This variability in total whole body counts is largely due tothe small number o f counts obtained (about 2,000 counts i n 20 minutes fora 4"x9" detector). Since NASA is interested in regional measurements o f muscle mass the detector can be placed very close and directly over the region of interest which greatly increases the counting efficiency. For the next two and one-half months, two 6" thick, 13-1/2" diameter NaI(Ta) detectors will be available for use in this study. When adult male thighs are measured between these two detectors,anet count o f 12,000 counts per 10 minutes will be obtained inthe40K photopeak. has a standard deviation of about tl% and 20-or 30-minute counts would be even more precise. i n each count, changes i n muscle mass which exceed 2% should be measurable. It i s hoped that atleast a 10% increase i n muscle mass can be obtained in the volunteers during the exercise period. With careful positioning of the legs If this technique proves satisfactory it will not only be useful inthe space program, but it may be applicable to several areas of medical research where 40K measurements have had limited use due to the previously large counting error. After several baseline counts each volunteer will be measured once each week until the end ofthe study. The counting measurements will be done in a mobile laboratory adjacent to the 329 Building where the large shielded detectors are located. Each volunteer will be paid an initial $50 for participating in the exercise program and another $50 upon completion ofthe program. In addition, he will be paid $10 for each weekly measurement so that his total payment will be between $200 and $250. It i s proposed that two adult male volunteers between the ages of 21 and 30 be used for the study. # The volunteers will be obtained from among students inthe Columbia Basin College Physical Education programs or patrons of a local health spa or participants in the forthcoming gymnastics program being offered by the Richland City Recreation Center. It i s planned that the volunteers will be exercising because of their own plans and not especially for this study. It i s planned that the ser - vices of a coach or instructor will be obtained toset up and zupervise the exercise program. Payment will be made for these services.
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Each volunteer will receive a medical examination by a consulting physician to determine his physical fitness and he will sign an informed consent form. this request for approval. The proposed consent form is attached t o
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INFORMED CONSENT FOR MUSCLE MEASUREMENT STUDY I agree to participate in a study for the purpose o f measuring increases i n muscle mass inthe upper and lower legs which will be produced by increased exercise. be prescribed by a professional coach or trainer. The subject will allow the muscles of his legs to be measured two times before the start of the exercise program and once each week for the duration of the study which will be eight toten weeks. The measurements will consist of placing radiation detectors above and below the legs and measuring the natural potassium which i s associated with all muscle tissue. The information obtained from this study will be used t o develop methods o f measuring muscle mass changes which may develop in astronauts during The exercise program will There are no known risks involved. The volunteers may withdraw Prom the study a t anytime without penalty of prejudice and will be paid according to the portion of the experiment completed. I understand the above procedure and have had an opportunity to