25 Clinical Trials for Various Conditions
Capsimax is a novel, proprietary encapsulated form of capsaicin, a natural and bioactive phytochemical found in chili pepper and other spicy food. The purpose of this study is to investigate the effect of Capsimax on resistance exercise performance, reaction time, and resting energy expenditure around exercise. This investigation will also measure muscle oxygenation and intramuscular nitric oxide in real time during resistance exercise using a non-invasive wearable technology. Primary Objective • To examine the effects of Capsimax on physical performance metrics including peak power and rate of force development during an isometric strength test and performance during the barbell back squat exercise protocol (e.g., repetitions performed, total volume, peak power, average power). Secondary Objectives * To examine the effects of Capsimax on resting energy expenditure around exercise. * To examine the effects of Capsimax on nitric oxide bioavailability and skeletal muscle oxygenation during exercise. Exploratory Objective • To examine the effects of Capsimax on reaction time around exercise
Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Additionally, persons with the disease typically need more than the usual calories on a daily basis. Most institutions estimate these patients' caloric needs using weight, age, and sex based mathematical formulae. However, numerous studies show that use of these formulae often yields inaccurate caloric values. Use of indirect calorimetry may give more accurate estimates of caloric needs in patients with cystic fibrosis. The aim of our study is to assess the accuracy of caloric estimates generated using one such widely used mathematical formula, the Harris-Benedict equation, and to compare this calorie value with that obtained from indirect calorimetry testing in pediatric and adult patients with cystic fibrosis. Study investigators will use the newly calculated caloric requirements in dietary counseling. Changes in weight and lung function after 3 months will be compared to participants' historical changes.
Patient nutritional needs vary depending on several factors including age, sex, height, weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this must be taken into account when assessing nutritional requirements. Indirect calorimetry will be used to measure energy expenditure of patients with decubitus ulcers of varying degrees. The primary objective of this study is to determine the effects of wound volume on metabolic rate and compare this to predictive equations used for estimating energy requirements.
This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.
Many Navy diving operations are performed in cold water. Despite technical advances to improve thermal protection for cold water diving, these applications are cumbersome and do not provide complete thermal protection as thermal discomfort is subjectively reported by many Navy divers. Brown adipose tissue is highly thermogenic in humans. Therefore, activation of brown adipose tissue might improve cold water tolerance and lower thermal discomfort during cold water diving operations. Mirabegron is a beta-3-adrenergic receptor agonist that is used to treat overactive bladder. Beta-3-adrenergic receptors are located on the urinary bladder, gallbladder and brown adipose tissue. Recent evidence has demonstrated that acute mirabegron administration increases thermogenesis for \~3 hours in humans. However, it is currently not known which dose of mirabegron can increase thermogenesis for longer durations. It is also not known if mirabegron administration can improve cold water tolerance and thermal discomfort during cold water immersion. Finally, it is not known if mirabegron can increase thermogenesis during sympathetic stimulation. This project will fill these knowledge gaps by determining if acute mirabegron administration will delay the fall in core temperature and the onset of shivering during a progressive cold-water immersion challenge. This study is part of a collection of studies that will show if mirabegron is a potential ergogenic aid that can be used to improve cold water tolerance in Navy divers which will ultimately improve the likelihood of successful missions.
Many Navy diving operations are performed in cold water. Despite technical advances to improve thermal protection for cold water diving, these applications are cumbersome and do not provide complete thermal protection as thermal discomfort is subjectively reported by many Navy divers. Brown adipose tissue is highly thermogenic in humans. Therefore, activation of brown adipose tissue might improve cold water tolerance and lower thermal discomfort during cold water diving operations. Mirabegron is a beta-3-adrenergic receptor agonist that is used to treat overactive bladder. Beta-3-adrenergic receptors are located on the urinary bladder, gallbladder and brown adipose tissue. Recent evidence has demonstrated that acute mirabegron administration increases thermogenesis for \~3 hours in humans. However, it is currently not known which dose of mirabegron can increase thermogenesis for longer durations. It is also not known if mirabegron administration can improve cold water tolerance and thermal discomfort during cold water immersion. Finally, it is not known if mirabegron can increase thermogenesis during sympathetic stimulation. This project will fill these knowledge gaps by determining which dose of mirabegron administration will increase thermogenesis during 6 hours of a mild cold stress challenge. This study is part of a collection of studies that will show if mirabegron is a potential ergogenic aid that can be used to improve cold water tolerance in Navy divers which will ultimately improve the likelihood of successful missions.
Young children have a high resting energy expenditure (REE) relative to their body weight and metabolically active compartment, fat-free mass (FFM). Both body weight and FFM are, however, metabolically heterogeneous and include organs and tissues varying widely in specific metabolic rate (i.e., organ REE/kg/d). One prevailing hypothesis is that most, if not all, of the higher REE observed in young animals and children compared to adults can be accounted for by a larger proportion of high metabolic rate components such as brain, liver, and heart..
This is a cross-over intervention study designed to evaluate how four weeks of time restricted feeding (16 hours fasting and 8 hours feeding), compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding), affects resting energy expenditure, subjective and biochemical markers of satiety and hunger, body composition, cardiovascular health, substrate utilization and fitness in male competitive runners.
This study is being done to learn more about energy needs and muscle function during treatment for bladder cancer. These insights can help improve future patient care. The study team found in a previous study that resting energy can be different than what estimates show. Patients with bladder cancer are known to suffer a decline in physical resilience over time. Monitoring patients to understand these changes better could help design future treatments with these vulnerabilities in mind.
Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing transcriptional level of protein synthase, while other high protein or amino acids like Glutamine or Arginine supplements only provide protein-amino acids pool for patients while body's preferred fuel during metabolic stress is endogens protein, rather than exogenous diet. In this study the investigators seek to achieve two distinct goals: 1. Determine the patients' nutritional status before and after major surgeries by baseline and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the investigators were going to use indirect calorimetry to determine the Resting Energy Expenditure (REE) in different phases of pre- and postoperative periods. The investigators also propose to compare different serum protein markers and their ratios in order to correlate them with ASPEN's criteria for nutritional status quantification. In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and serum biomarkers are going to be used in conjunction with each other to delineate the patients' nutritional status in various pre- and post-operative periods. 2. Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve their nutritional status and improve postoperative outcomes. The investigators looked for depict meaningful improvements in surgical outcomes by nutritional supplementation with or without HMB.
The purpose of this project is to test, for the first time, a reverse diet in adults with current or prior overweight/obesity (Ow/Ob). Weight-reduced adults with current or prior Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for 12 weeks. Eligible participants will have lost \>10% body mass. The reverse diet group will receive personalized caloric intake goals, increasing 2-3%/week. The CON group will receive standard weight maintenance recommendations with matched contact. At baseline and week 12, resting energy expenditure (REE), body mass and composition, subjective appetite, and food intake behaviors will be evaluated. In addition to the pre- and post-intervention measures, body mass and adherence to reverse diet will be monitored weekly.
Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of disorder-related fatigue, however, it is unknown whether PD or MS patients experience compromised blood lactate responses to an acute bout of exercise, subjecting them to exercise-related fatigue. These populations may experience higher energy expenditure at rest due to increased rigidity, however, limited data exists investigating resting energy expenditure in these populations. Researchers hypothesize that PD and MS patients will display higher resting energy expenditure than healthy age-matched controls, and that level of energy expenditure will correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels of lactate will not be different between PD/MS and control groups, but post-exercise blood lactate levels will be significantly higher in the PD/MS groups.
This research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest.
Background: - Changes in how a person's body burns energy or calories can affect their weight over time. The lowest level of energy the body needs to function is called basal metabolic rate. In the cold, we burn extra energy, even before we start to shiver. This is called non-shivering thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers want to learn more about this type of energy burning and how it is regulated. They hope this will help treat obesity in the future. Objectives: * Sub-study 1: to better understand how non-shivering thermogenesis works. * Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate. * Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic receptor agonist, on brown fat activity. Eligibility: - Healthy, lean adult males ages 18 to 35. Design: * Participants will be screened with medical history, physical exam, blood test, and EKG. * For sub-studies 1 and 2: * Participants will receive one X-ray scan. * Each day, all participants will: * Have height and weight measured, and have urine collected. * Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering. * Walk for 30 minutes. * For sub-study 3: * Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs * Each stay, all participants will: * Have height and weight measured, and have urine collected. * Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering. * Participants will be compensated for their time and participation at the end of the study
Background: - RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it is not fully known whether RM-493 causes weight loss by just decreasing appetite or by increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite by assessing feelings of hunger and fullness. They will study this drug in people who are obese but are otherwise in good health. Objectives: - To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy individuals. Eligibility: - Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40 kg/m2) but are otherwise healthy. Design: * The study consists of three phases. The first phase is the screening visit. The second phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week after the end of the second phase. * Participants will be divided into two groups. One group will receive the study drug first, followed by a placebo. The other group will receive the placebo followed by the study drug. The study drug and placebo will be given under the skin for 3 days each by a small device (OmniPod) that normally is used to give insulin to people with diabetes. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also meet with a dietitian. The OmniPod device will be demonstrated before use. * Participants will have the following procedures during their 8-day inpatient stay: * Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles per hour) during an exercise test * Wear physical activity monitors * Body composition study to measure amounts of fat and muscle * Calorie controlled study diet * Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7) * Metabolic rate studies using a cart or the metabolic chamber * Daily blood samples * Urine collection for 24 hours * Questions about weight history and appetite * About a week after the inpatient stay, participants will have a followup phone call to ask about any side effects from the study.
The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.
Purpose is to determine the effect of ephedrine and caffeine, on metabolic rate and weight loss after bariatric surgery. Approximately 40% of patients struggle with their weight loss rate, or metabolic rate, after bariatric surgery, and at least 30% previously had or develop a low metabolic rate after surgery. Metabolic rate is the speed at which calories are burned. The fewer the calories eaten and the more calories burned, the more rapidly weight is lost. It is possible that despite a very low calorie intake following bariatric surgery metabolic rate will decrease so much so that weight does not decrease even if intake is reduced to 1000 calories per day. Ephedrine is a medicine used commonly to treat asthma, difficulty breathing, and wheezing. However, 40 years ago it was reported in scientific studies that ephedrine increases weight loss in patients on low calorie diets by increase the amount of calories that are burned. Combining caffeine with ephedrine makes ephedrine work more efficiently (more weight loss over time). Many studies show the effect of ephedrine on weight loss that began in 1974 with patients on food diets. Ephedrine used in various strengths and with a number of different combinations has shown to be effective and safe, especially when directed by a physician. There is only one study where ephedrine has been used in patients after bariatric surgery. In that study, both the patient and medical staff knew they were taking ephedrine (i.e., they were not "blinded"). The patients who were not losing weight or had measured low metabolic rates were treated with ephedrine. The patients taking ephedrine lost more weight after surgery than those not taking ephedrine. While this is a significant finding, the study was not designed to be the best test of the effects of ephedrine. The best test is where neither the patients nor the medical staff know if the patient is taking the active drug (double blind). All patients enrolled into the Research Study will receive capsules that contain either ephedrine and caffeine (the active drug) or identical capsules with no active ingredient (called a "placebo"). Neither group of patients will know which set of capsules they receive. The expected duration of treatment in the Study is 7 months from the day of surgery. This is a single site study. All patients will have their gastric bypass performed through Oregon Weight Loss Surgery at Legacy Good Samaritan Hospital. The investigators expect to study 200 patients with 100 receiving the study drugs (ephedrine and caffeine in a capsule) and 100 receiving placebo (inactive ingredients in an identical capsule) over approximately 6 months.
The primary purpose of this study is to expand research on the effects of physical activity on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training program. The investigators will measure BMR by indirect calorimetry and normalize it across subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will be compared: an intervention group (no previous participation in regular exercise, newly enrolled in this study's 16 week training program), and a long-term athlete group (have engaged in at least 5 hours of exercise per week for the past 10 years or longer). A secondary aim is to generate an equation for the prediction of BMR from fat free mass in physically active postmenopausal women, to be applied to hypotheses in biological anthropology. The investigators expect to find at baseline that, controlling for fat free mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention group. At 16 weeks the investigators expect no change in BMR for the long-term group, while BMR will have increased in the intervention group. At the same time, the investigators expect to find that after completing the training regimen, the intervention group will have BMR similar to that of the long-term athletes.
The aim of this study is to measure important components of weight change in patients who underwent bariatric surgery on measures of fat mass and its distribution and fat-free mass (FFM) (bone mineral density, skeletal muscle, and specific organs) at 60 months (T60) and 84 months (T84) post-surgery, and to compare compartment sizes with stable weight controls.
The purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. This study will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger.
In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.
This study will explore factors that affect obesity and obesity-related diseases in both Caucasians and African Americans. By looking at the rate at which the human body burns calories while at rest (resting energy expenditure, or REE) and at the rate at which fat travels through the blood (fatty acid flux), this study will examine the relationship between REE and fatty acid flux, both of which are determinants of obesity. Researchers will compare the test results of Caucasians and African Americans to determine if race has an effect on the relationship between REE and fatty acid flux. Volunteers must be between 18 and 49 years of age. Equal numbers of typical weight, overweight, and obese participants will be recruited. Candidates will be screened with a physical examination, electrocardiogram, and blood tests, and will be interviewed about diet and exercise habits, family and medical history, and employment. Participants will be placed on a two-week maintenance diet (prepared by a dietician to regulate and maintain calorie consumption) and must visit an outpatient clinic for weight measurement for 10 consecutive weekdays. During the two-week diet, participants will also undergo two 20-minute computerized scans to measure abdominal and body fat. At the end of the two weeks, participants will then be hospitalized for two days to allow researchers to conduct blood tests, oral glucose tests, and a physical examination to measure REE and fatty acid flux levels for comparison.
The aim of the study is to investigate the effects of capsaicin rich foods on resting energy expenditure and substrate oxidation. We plan to recruit 30 healthy lean and overweight individuals age 18-45 (women) and age 18-50 (men) who will undergo two test days in random order. During one day they will receive a breakfast of toast, orange juice and an omelette with 4tsp of cayenne pepper while on the other day they will receive the same breakfast without the cayenne pepper. Metabolic rate and Respiratory quotients is measured for 30 minutes before the meal and for 2 hours after the meal. Capillary glucose levels and heart rate and blood pressure are measured before the meal and every 30 minutes thereafter for 2 hours.
The purpose of this study is to compare the effect of ingesting caffeine and mixed flavonoids (4 capsules, split between breakfast and lunch) on energy expenditure and fat oxidation in a metabolic chamber with 20 women (non-obese, healthy, ages 20-47 years, pre-menopausal). We hypothesize that based on the existing literature, ingestion of a double dose of the caffeine-mixed flavonoid supplement compared to placebo will increase fat oxidation and increase 24 h energy expenditure by about 75 kilocalories.
Each 4-day period will follow the same protocol. Basically, for the entire study, we will prepare all of the subject's food and will require him or her to eat all of the food that we give at the times we tell them to eat. The subject will arrive at the hospital on the evening of day 1, and become inpatients. On day 2, the subject will be permitted to leave the hospital campus under the supervision of the research staff. On day 3, they will be required to stay in a small room called a metabolic chamber for 24 hours. This room measures how many calories you burn in one day. On day 4, we will measure the subject's energy expenditure in response to a breakfast meal. They will be given breakfast and the number of calories that they burn after that meal will be measured over a 6-hour period. Then the subject will be discharged at the end of the test. The 2 study periods will differ only in bedtimes and wakeup times. During one period, the subject will go to bed at 1 am and wake up at 5 am and during the other period they will go to bed at 11 pm and wake up at 7 am.