28 Clinical Trials for Various Conditions
This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.
Given both the increasing population impact of atrial fibrillation (AF) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on AF is of great clinical relevance. This pilot study will evaluate the effect of randomly assigning participants undergoing electrical cardioversion to coffee abstinence or coffee consumption over a 6 month period. This pilot study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not coffee has any effect on AF recurrence.
The present study determined the effects light, medium, and dark roasted, brewed coffees on blood glucose responses in normal (n = 19) subjects.
The purpose of the study is to determine if providing coffee to patients who self-identify as coffee drinkers postoperatively will decrease the length of stay in the post-anesthesia care unit (PACU).
Atrial fibrillation (AF) and heart failure (HF) are morbid, costly, and incompletely understood diseases that have reached epidemic proportions worldwide. A dose-dependent relationship exists between premature atrial and ventricular contractions (PACs and PVCs) and development of AF and HF, respectively. Identifying and understanding the mechanisms of additional modifiable risk factors for ectopy has the potential to markedly reduce the healthcare burden of these diseases. In considering how to modify the prevalence of these ectopic beats, the investigators believe common exposures in daily life are prime candidates. Current guidelines suggest that caffeine may be an important trigger for frequent ectopy, although large population-based studies have not demonstrated an association between caffeine consumption and development of clinically significant arrhythmias. No study has employed an actual randomization intervention to assess the effects of caffeine on cardiac ectopy. Utilizing the Eureka platform, the investigators plan to utilize the N-of-1 strategy to rigorously investigate the real-time effect of caffeine intake on ectopy.
The primary objective is to test if acute supplementation with Coffee would improve antioxidant status, following consumption of a pro-oxidative high carbohydrate, high fat meal in over weight/ obese humans. Secondary objective is to determine the ability of coffee to modify postprandial inflammation in overweight/ obese humans.
The purpose of this study is to evaluate whether taking thyroid hormone medication with beverages other than water, decreases absorption of the medication by the intestine. Specifically we are interested in whether coffee, coffee with milk, or black tea affects how thyroid medication is absorbed by the body. Previous studies have suggested that taking thyroid hormone with coffee may interfere with the ability to absorb thyroid medicine. Given that many patients take their thyroid medicine with beverages other than water, and specifically with coffee or tea, understanding whether and how much coffee or tea may decrease thyroid hormone absorption is important for clinical practice. This study will help determine the safest and most effective way for adults to take their thyroid medication and will guide medical practitioners in how to counsel their patients when they prescribe thyroid hormone.
The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans
In this study, participants will be eligible to participate in a paid research study that will examine the effects of regular coffee drinking. The study takes approximately 2 hours total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink only coffee provided to them during the study.
Habitual consumption of coffee may have substantial beneficial effects on glucose metabolism according to recent findings of epidemiological studies in the U.S., Europe, and Japan. However, data from longer-term human intervention studies with appropriate outcome measures are lacking. We will study the effects of caffeinated and decaffeinated coffee consumption on body fatness, insulin sensitivity and glucose tolerance that may underlie the observed associations with a lower risk of type 2 diabetes in a randomized controlled trial. We hypothesize that both caffeinated and decaffeinated coffee will improve insulin sensitivity and glucose tolerance. Before starting a larger, long-term intervention study, we will conduct a pilot study to test the feasibility of such a trial. The pilot study will be an 8-week parallel trial in 45 overweight individuals, who will be randomized to drinking 5 cups per day of 1) caffeinated coffee (n=15), 2) decaffeinated coffee (n=15), or 3) water (n=15). Body fatness (weight, waist circumference, bioelectrical impedance), insulin sensitivity (HOMA model), and glucose tolerance (oral glucose tolerance test) will be the primary outcomes. We will assess the adherence of participants to their assigned treatment by measuring serum caffeine concentrations, documentation of coffee use in diaries by the participants, and counting unused coffee packets. We will also obtain feedback from participants on how to improve compliance in a future trial. If successful, this study will form the basis for a definitive trial of coffee consumption, body fatness, and glucose tolerance. Given the extensive use of coffee and the rapidly increasing health burden of type 2 diabetes, such a trial would have important public health implications.
This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy.
Coffee has been found to have beneficial effects on cognitive function and blood sugar control. Benefits include reduced risk of cognitive decline and improved performance on cognitive tests, as well as reduced risk of diabetes and improved blood sugar control in people with diabetes, a population that is at a higher risk of cognitive decline. These effects have been observed for both caffeinated and decaffeinated coffee, and have been associated with the polyphenol chlorogenic acid (CGA). This polyphenol has been found to be more bioavailable in certain coffees, known as "speciality coffee" as defined by the Specialty Coffee Association of America, depending on agriculture, roasting, and brewing method. This current project will bring together these previous findings to explore the effects of specialty coffee on cognitive function and glycaemic control in people with type 2 diabetes through a randomized control trial with two groups: a high CGA specialty coffee group and a conventional coffee control group. Participants will be quasi-randomly assigned to one of these two groups following the completion of a 4-week run-in period during which participants will consume conventional coffee only. The length of the experimental arms is 8 weeks, therefore the total length of the study is 12 weeks. At the beginning and the end of each experimental arm participants will undertake a cognitive assessment online using the Gorilla platform, and a series of questionnaires relating to health and mood measures (details in procedure). Cognitive function will also be assessed at the beginning of the 4-week run-in period.
There has been increasing interest in natural dietary supplements that may support healthy cognition. Recent studies have demonstrated promising effects of bioactive phytochemicals (e.g., polyphenols) on cardiovascular and endocrine health outcomes. As such, an increasingly intriguing line of inquiry is whether materials high in these compounds may also have effects on psychological measures. Preliminary evidence suggests that polyphenols may improve cognition, for example, particularly in aging populations. Whole coffee cherry extract (WCCE; otherwise known as the generally-recognized-as-safe (GRAS) supplement Neurofactor(TM)), is a proprietary, safe, powdered extract of whole coffee cherries from coffea arabica with high levels of polyphenols and substantially low (\<2%; \<4mg) levels of caffeine. WCCE has been previously associated with increased serum concentrations of both circulating and exosomal brain derived neurotrophic factor (BDNF), in addition to increased alertness and decreased fatigue. However, few well-powered and well-designed studies have been conducted despite the mounting preliminary evidence. Here, the investigators propose a study to examine the long-term effects of a 200mg dose of WCCE on measures of cognition.
The primary purpose is to test the short-term effects of the acute consumption of two novel beverages made from coffeeberries, the fruit of the coffee plant (Coffea arabica) benchmarked against caffeine on several aspects of cognitive performance. Preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive performance. It is unknown if drinks formulated with flavanols and chlorogenic acids (without high sugar or caffeine) improve cognition or mood to a similar extent as caffeine. Coffeeberry beverage comparisons will be made to a flavored positive control beverage containing caffeine and a flavored placebo beverage.
Undergoing anesthesia requires patients to fast pre-operatively to allow the stomach to empty and prevent aspiration pneumonia but patients are allowed to drink "clear" liquids up to 2 hours before surgery. Clear liquids are defined as water, carbonated sodas, black coffee or tea without milk or sugar, and juices without pulp. Many Americans prefer to take their coffee with half and half or coffee creamer rather than black. This study will determine whether the addition of a small amount of cream to coffee makes any difference to the volume in the stomach after 2 hours. This study will use healthy volunteers as study participants. Each participant will participate in the study 3 times with at least 2 days in between. We will use a bedside ultrasound machine to measure their stomach content volume at baseline and then they will consume one of 3 different prepare drinks - black coffee, coffee with half and half, or coffee with non-dairy coffee creamer. After 2 hours, we will scan their stomach again and measure stomach content volume and compare it to the first measurement. The participants will repeat this two more times on different days so that they would have had a chance to consume all three prepared coffee drinks in a random order.
The purpose of this randomized, double-blind, crossover study is to investigate the effects of Bang® Keto Coffee on resting and post-exercise metabolism and muscular performance during lower body resistance exercise.
The purpose of this study is to help further the understanding of the effects of commercially available high-caffeine containing coffee on blood pressure in healthy adult subjects.
Over 1.25 million Americans have Type 1 Diabetes (T1D), increasing risk for early death from cardiovascular disease (CVD). Despite advances in glycemic and blood pressure control, a child diagnosed with T1D is expected to live up to 17 years less than non-diabetic peers. The strongest risk factor for CVD and mortality in T1D is diabetic kidney disease (DKD). Current treatments, such as control of hyperglycemia and hypertension, are beneficial, but only partially protect against DKD. This limited progress may relate to a narrow focus on clinical manifestations of disease, rather than on the initial metabolic derangements underlying the initiation of DKD. Renal hypoxia, stemming from a potential metabolic mismatch between increased renal energy expenditure and impaired substrate utilization, is increasingly proposed as a unifying early pathway in the development of DKD. T1D is impacted by several mechanisms which increase renal adenosine triphosphate (ATP) consumption and decrease ATP generation. Caffeine, a methylxanthine, is known to alter kidney function by several mechanisms including natriuresis, hemodynamics and renin-angiotensin-aldosterone system. In contrast, to other natriuretic agents, caffeine is thought to fully inhibit the local tubuloglomerular feedback (TGF) response to increased distal sodium delivery. This observation has broad-ranging implications as caffeine can reduce renal oxygen (O2) consumption without impairing effective renal plasma flow (ERPF) and glomerular filtration rate (GFR). There are also data suggesting that chemicals in coffee besides caffeine may provide important cardio-renal protection. Yet, there are no data examining the impact of coffee-induced natriuresis on intrarenal hemodynamic function and renal energetics in youth-onset T1D. Our overarching hypothesis in the proposed pilot and feasibility trial is that coffee drinking improves renal oxygenation by reducing renal O2 consumption without impairing GFR and ERPF. To address these hypotheses, we will measure GFR, ERPF, renal perfusion and oxygenation in response to 7 days of cold brew coffee (one Starbucks® Cold brew 325ml bottle daily \[205mg caffeine\]) in an open-label pilot and feasibility trial in 10 adolescents with T1D already enrolled in the CASPER Study (PI: Bjornstad).
Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the effect of an increased coffee intake on resident burnout has not been reported in the literature. This study is a prospective, interventional cohort study enrolling up to 50 residents from the Internal Medicine Residency Program to look at the relationship between coffee and resident burnout.
Post-operative ileus ("post-op ileus") is a condition which can occur after surgery. This means that the bowels stop working correctly and food and liquids will not pass through in the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay until the bowels begin to function correctly again. Currently there are no effective methods for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee following colon or gynecological cancer surgeries with very little risk. However, the effects of coffee following small bowel surgery have not been studied. This randomized, controlled trial will compare the outcomes of patients who receive coffee during their hospital stay after small bowel surgery to similar patients who receive warm water. About 60 patients will be in each group. The main outcomes are time until the nasogastric tube is removed and length of hospital stay.
The effects of coffee have been shown to act as a colonic stimulant. Caffeinated coffee stimulates colonic activity, most notably in the transverse/descending colon, in magnitude similar to a meal, 60% stronger than water, and 23% stronger than decaffeinated coffee. \[1\] Moreover, the consumption of both water and caffeine causes a decrease in the rectal sensory threshold for the desire to defecate, while anal sphincter pressure after caffeine intake is significantly higher than after water intake. This may result in an earlier desire to defecate. \[2\] Coffee has also been shown to have an effect on defecation by increasing rectal tone by 45% (measured with a barostat) thirty minutes after consumption. \[3\]
The purpose of this pilot study is to evaluate the potential effects of whole coffee fruit concentrate (WCFC, Neurofactor), a product that elevates circulating brain-derived neurotrophic factor (BDNF), on cognition and mood in healthy adults. The projected outcome of this study is that self-administration of Neurofactor for 28 days (or even 14 days) will be associated with an improvement in mood and scores on cognitive tests, and that the change will exceed that observed with administration of Nutrim (placebo). Volunteers will be recruited from the greater Los Angeles community. Participants will be middle-aged nonsmokers, in good health, and between the ages of 40-55 to enhance the chance of demonstrating pro-cognitive effects. Younger participants, whose cognitive performance is expected to be higher, may perform at a ceiling level, with less room for improvement by the product under study. Participants who call our lab will be told about the study in more detail, and will complete a 5 minute phone screener to determine preliminary eligibility. After the initial telephone screening, participants will visit Dr. London's laboratory at UCLA to provide written informed consent. The first study visit will be an in-person screening visit to determine full eligibility. The evaluation will include a psychiatric diagnostic interview, using the SCID, blood tests, urine samples (to test for drug use and pregnancy). Participants will also be interviewed about their prior and current drug use, including tobacco use. In addition, participants will be interviewed about the nature of their employment and physical exercise habits: endurance training has been shown to increase plasma BDNF in young men. Participants meeting the inclusion criteria will attend the Semel Institute for Neuroscience and Human Behavior at UCLA to take part in baseline measurements, and to be randomized to receive either WCFC or placebo. During the active treatment time (28 days), they will visit the UCLA Semel Institute on a weekly basis. At each of these weekly visits, questionnaires regarding compliance will be completed, and blood samples will be taken for assay of BDNF. A cognitive test battery and mood-rating scales will be completed at baseline and at 14 and 28 days of treatment. At the midpoint assessment (14 days) and at completion of treatment (28 days) blood will be drawn for assay of a blood chemistry panel (as at baseline) as well as for biomarkers in addition to BDNF.
High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). There is controversy in the literature regarding the degree to which caffeine influences IOP, with some studies reporting minimal changes in IOP while others report up to 4 mmHg increases. To date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for primary open-angle glaucoma. The investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a double-masked, crossover randomized controlled clinical trial.
The purpose of this study is to determine if consuming an 8 ounce cup of coffee with breakfast and lunch is effective in preventing or reducing postoperative ileus.
The goal of this study is to establish the role of coffee mannooligosaccharides (MOS), provided in a beverage format, on body weight regulation. Overweight and obese men and women will be randomized to one of 2 groups: placebo or MOS beverage. They will be required to consume 2 beverages/day for the duration of the 2 phases of the study. The MOS beverage will provide 2 g of MOS (total of 4 g/d). This dose level has been found to be well tolerated and safe. In the first phase, subjects will be counseled once monthly on a nutrition-related topic on an individual basis. They will be asked to maintain their regular eating and exercise habits for the duration of the 12 week period. An 8-week washout period will follow during which time they will not be required to consume the beverages. The second phase of the study will be a weight loss phase. For this phase, subjects will be re-randomized and may consume the alternate or the same beverage as the first phase, depending on the outcome of randomization. During this phase, they will undergo group counseling on a weekly basis. Counseling sessions will focus on weight loss and ways to achieve moderate weight loss of approximately 1-2 lbs/week. Measurements will be taken at the beginning and end of each phase. This study will allow us to determine whether MOS helps maintain body weight and prevent weight gain (first phase) and whether it helps to stimulate weight loss (second phase). The results will allow us to find ways in which overweight and obese individuals can incorporate beverages in their diets that will help promote weight loss.
Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.
This is a phase I dose-escalation study of Artemisia annua (Aa) in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. The primary objective of this study is to determine the recommended phase II dose (RP2D) of Artemisia annua.