Progress 07/01/13 to 06/30/15
Outputs
Target Audience:Overweight/obese adults and older children comprise the target audience. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?The project has provided siginificant training and professional development for the graduate student research assistants associated with the study, but also to other graduate and undergraduate student research assistants who have worked on the project but have not received financial reimbursement (ie., they do not receive a stipend from the project). Newly acquired skills and experiences include the performance of indirect calorimetry, phlebotomy, and collection and analysis of body composition data via dual energy X-ray absoprtiometry. Further, all students have completed training pertaining to Human Subjects Testing, Operation of Radiation Producing Apparatus, Hazardous Waste Disposal, and Blood Born Pathogens. The project has provided an opportuity for graduate students to be involved with a study from its inception, through evaluation and approval from various regulatory offices, subject recruitment, screening, scheduling and retention, and finally data collection, analysis and dissemination. Finally, the project has provided a graduate student with a topic for a Master's Thesis (to be defended Spring 2016). How have the results been disseminated to communities of interest?Preliminary data have been presented at an intramural event (Graduate Student Showcase). What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
11 overweight/obese adults/older-children participated in this study. Research participants were assigned to one of two conditions: daily consumption of a placebo (something that has no effect) or daily consumption of the nutraceutical. Prior to and following each treatment body composition, resting metabolic rate, thermic effect of feeding, metabolic responses to standardized exercise, and blood pressure were determined. There were no differences between each of the treatment groups at baseline. Compared with the placebo treatment, daily consumption of the nutraceutical did not influence total body mass, fat-free mass, or fat mass. Consistent with these data, resting metabolic rate, the thermic effect of feeding and the metabolic responses to standiardized exercise were all unaltered. Finally, neither blood pressure nor resting heart rate were not influenced by the nutraceutical compared with the placebo treatment. These data imply that the nutraceutical does not influence energy expenditure and/or basal cardiovascular function.
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Progress 10/01/13 to 09/30/14
Outputs
Target Audience: Overweight/obese adults and older children comprise the target audience. Changes/Problems: In order to study energy expenditure during physical activity, we proposed to collect gas exchange data, for indirect calorimetry, during standardized work loads on a stationary cycle ergometer. Originally we proposed that participants would exercise for 3 consecutive 10-minute periods at an external work rate of 50, 100 and 200 Watts. Our rationale was these external work rates would be sufficient to evoke a sympathetic response and yet be accomplishable for the proposed research participants. During data collection from the first cohort of participants, it very quickly became apparent that these workloads were too strenuous. We have since decreased the workloads to 25, 75 and 125 W and allowed brief rest periods between each increment. Thus far, all participants have been able to complete the new standardized exercise. What opportunities for training and professional development has the project provided? The project has provided siginificant training and professional development for the graduate student research assistants associated with the study, but also to other graduate and undergraduate student research assistants who have worked on the project but have not received financial reimbursement (ie., they do not receive a stipend from the project). Newly acquired skills and experiences include the performance of indirect calorimetry, phlebotomy, and collection and analysis of body composition data via dual energy X-ray absoprtiometry. Further, all students have completed training pertaining to Human Subjects Testing, Operation of Radiation Producing Apparatus, Hazardous Waste Disposal, and Blood Born Pathogens. By its completion, the project will have provided an opportuity for graduate students to be involved with a study from its inception, through evaluation and approval from various regulatory offices, subject recruitment, screening, scheduling and retention, and finally data collection, analysis and dissemination. How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? During the remainder of the funding period (that is, between now and June 30) we will continue to recruit study participants. The relative short duration of the intervention promotes the feasibility of fresh study enrollment without delaying eventual study completion. Following completion of data collection and statistical analysis the research team will be un-blinded as to the treatments (placebo vs. nutraceutical). Documents for data dissemination will be prepared; these will include a conference abstract and a scientific manuscript. Target journals for the data collected as part of the current proposal include the American Journal of Clinical Nutrition, Obesity, and the American Journal of Physiology: Endocrinology and Metabolism. Target scientific meetings will include both local and national scientific meetings, such as annual meetings of the Obesity Society, American Diabetes Association, the Endocrine Society, and Rocky Mountain Chapter of the American College of Sports Medicine (RMACSM).
Impacts
What was accomplished under these goals?
We were able to purchase each of the components of our nutraceutical from a GMP compliant and certified company, and subsequenlty assemble the nutraceutical. We have sucessfully recruited, screened, and enrolled overweight and obese men and women for study participation. The physical characterisitics of these participants are as follows: age 41 + 7 years; body mass index 31.1 + 1.9 kg/m2; waist-to-hip ratio 0.86 + 0.06; % body fat 41.0 + 1.9; and maximal oxygen uptake 26.0 + 3.5 ml/kg/min (mean + SE). From these participants we have sucessfully collected preliminary data, pertaining to resting metabolic rate, the thermic effect of feeding, and energy expenditure associated with physical activity, in addition to collecting biological tissue samples (e.g. blood), that are currently in frozen storage. Due to the double-blind nature of the study design, we are currently unable to speculate as to the effectiveness of the intervention. All data collection completed thus far has been performed in the absence of any adverse events. Institutional Review Board approval for the project was successfully renewed.
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Progress 07/01/13 to 09/30/13
Outputs
Target Audience: The target audience is comprised of overweight/obese adults and children. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided? The graduate student research assistant, through the performance of the pilot studies completed thus far, has acquired all of the skills necessary to complete the data collection associated with this project. How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals? We have developed a recruitment plan to enroll the required number of research participants needed to investigate the hypotheses associated with the project. In light of the current month (January), the target audience (overweight/obese adults and children), and the trend for weight loss resolutions during this time of year, we are confident that the timing of our recruitment will yield success.
Impacts
What was accomplished under these goals?
Institutional Review Board approval for this project was obtained in August 2013. Since then we have sucessfully completed a series of pilot studies on a small group of overweight/obese adults and children to optimize our research techniques. We have also identified a GMP compliant and certified company capable of supplying each of the components of the nutraceutical to be evaluated.
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