Treatment Trials

253 Clinical Trials for Various Conditions

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COMPLETED
Effectiveness of Changing Dietary Fat on Weight Loss
Description

This study will compare two energy reduced diets; one diet will include one Haas avocado/day while the other diet will follow the usual American dietary pattern. All subjects will receive a dietary plan that reduces their usual intake by 500kcal/day with the same percentage of fat, protein and carbohydrates. The results from this study may help to explain if eating one Haas avocado/day can achieve at least equivalent weight loss when compared to the usual American diet.

Conditions
COMPLETED
The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults
Description

The purpose of this study was to determine the effect of different dietary fats (saturated or unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial endotoxemia.Participants were recruited via email and randomized to treatment meal in this single-blind, cross-over study. Each test session participants reported to the laboratory right away in the morning. An indwelling catheter was inserted into the participant non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant was then provided with one of four test meals (a porridge-type meal containing a different dietary fat), which they ate in entirety within 15 minutes. The participants remained in the laboratory for the next five and a half hours and were not allowed to consume any food or drink except water. During this time, further blood draws were taken at intervals of one hour for a total of five hours after the consumption of the test meal. Collected blood was processed on-site and the serum fraction collected and tested for endotoxin, inflammatory biomarkers, and metabolites.

Conditions
COMPLETED
Pilot Study to Test Dietary Fat Delivery
Description

The average American diet consumed by a significant proportion of the adult population, supplies excessive calories and large amounts of saturated fat. Saturated fats can be cleared and used in skeletal muscle, but in obese individuals, biomarkers of saturated fat are found in the blood, along with markers of poor muscle metabolism. Both fats and amino acids are processed by the same metabolic pathways in muscle, and the investigators hypothesize that meals with greater amounts of saturated fat slow muscle metabolism. A better understanding of the interaction of these to metabolites will allow for the development of future medications to treat muscle loss in sick individuals and the elderly.

WITHDRAWN
Effect of Pumpkin Seeds on the Dietary Fatty Acid Intake and Blood Pressure in Women
Description

The purpose of this study is to determine if the inclusion of 1.5 ounces of pumpkin seeds per day in the diet of women will alter dietary fatty acid intake or blood pressure.

TERMINATED
Dietary Fat Levels and Abiraterone Acetate Uptake in Patients With Metastatic Hormone-Resistant Prostate Cancer
Description

This randomized pilot phase I trial studies the side effects of dietary fat levels and abiraterone acetate uptake in patients with metastatic hormone-resistant prostate cancer. Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Eating a low or high fat diet may increase the uptake of abiraterone acetate.

COMPLETED
Dietary Fat, Eicosanoids and Breast Cancer Risk
Description

The primary objective of this investigation is to determine whether diets designed to increase plasma n3 concentrations (a low fat diet, with or without n3 fatty acid enrichment), will favorably affect sex hormone distribution in women in a direction associated with reduced risk of sex hormone-mediated cancer development. Specifically, we hypothesize that an increased concentration of circulating n3 fatty acids will reduce the biochemical markers associated with increased risk for developing certain sex hormone mediated cancers such as breast cancer

Conditions
COMPLETED
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
Description

The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich in medium chain triglycerides on energy expenditure and food intake in overweight and obese children.

COMPLETED
Does Class of Dietary Fat Affect Insulin Resistance?
Description

It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. The investigators are specifically interested in whether or not there are differences in the induction of insulin resistance between the 3 main classes of fatty acids (saturated, monounsaturated and polyunsaturated). The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.

COMPLETED
A Pilot Study of the Effect of Dietary Fat Type and Amount on Vitamin D3 Absorption
Description

This study will examine whether the amount and type of fat, mono-unsaturated fat (MUFA) vs. poly-unsaturated fat (PUFA), in a meal affects the absorption of vitamin D, which is taken after that meal. The study hypothesis is that vitamin D3 absorption will be greater when fat is present vs. absent in the meal. A secondary hypothesis is that vitamin D3 absorption will be greater in the presence of a meal with a high MUFA/PUFA compared with a low MUFA/PUFA ratio.

COMPLETED
Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities
Description

Individuals have a significant capacity to adapt to different environments by changing their core metabolic pathways. This adaptation is especially important in regards to diet. Epidemiological research over the last several decades have shown that diets high in saturated fats have a greater ability to cause insulin resistance and the 'metabolic syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as compared to high carbohydrate or high saturated fat diets, result in increased insulin sensitivity and improved lipid profiles. In this application, the investigators propose to systematically assess the effects of two diets enriched in either saturated or unsaturated fatty acids and determine the cellular and molecular mechanisms of the apparent increase in insulin sensitivity. The investigators hypothesize that individuals will 'adapt' to the different diets and the investigators will be able to generate predictive alterations in gene expression and metabolites that underlie the alterations in metabolism. In parallel, the investigators will test the ability of these different diets to affect the release of gastrointestinal hormones that may be critical to modulation of appetite.

COMPLETED
Dietary Fat and High-Density Lipoprotein (HDL) Metabolism-Effect of Carbohydrate and Fat Intake
Description

Generally, people with low levels of high-density lipoprotein (HDL) in blood are more likely to get heart disease than those who have normal or high levels. Dietary fat, whether the harmful type (saturated) or beneficial type (unsaturated) raises HDL levels. Dietary carbohydrate lowers HDL. The investigators are doing this research study to find out why the amount of HDL in a person's blood is affected by dietary unsaturated fat and carbohydrate. The investigators will trace the ability of the HDL in a person's blood to take up cholesterol, get bigger, and then leave the blood by passing into the liver. The investigators want to know if dietary unsaturated fat improves the ability of HDL to do this compared to dietary carbohydrate.

COMPLETED
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes
Description

The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.

Conditions
COMPLETED
Oscillations of Dietary Fat/Carbohydrate Intake Over Interval of 3 to 4 Days
Description

The purpose of this study is to understand the mechanisms for oscillations of dietary fat/carbohydrate intake and how fat intake affect insulin resistance and liver fat over interval of 3 to 4 days.

Conditions
COMPLETED
Effect of Dietary Fat When Eaten With Fructose Versus Glucose
Description

This study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy.

COMPLETED
Dietary Variety Versus Dietary Fat Effects in Energy Intake
Description

The relative importance of dietary patterns vs. macronutrient composition in affecting energy intake and body weight remains uncertain. In this study we propose to investigate the relative effects of dietary variety vs dietary fat on voluntary energy intake in adults. We will quantify and compare the effects of typical ranges of variety \& fat intakes in the American diet on voluntary energy intake. The primary hypotheses to be tested are 1)an increasing availability of entree/side/snack/dessert variety offered will significantly increase voluntary energy intake in a dose-response fashion when other dietary factors known to influence energy intake are held constant. 2)The separate effects of dietary variety \& dietary fat on energy intake will be similar. We anticipate that the results of this investigation will lead to a greater understanding of the relative importance of eating patterns versus macronutrient composition in the etiology of obesity, and more specifically, dietary variety versus dietary fat in determining energy intake. More importantly, it will help lay a foundation for improved dietary recommendations concerning weight loss and prevention of excess weight gain in adulthood.

Conditions
COMPLETED
Differential Metabolism of Dietary Fatty Acids
Description

Differences in how diet fats are converted to energy could explain some of the reported differences in health effects among different classes of dietary fat (e.g. monounsaturated vs. saturated). Recently, this laboratory showed that monounsaturated fats are turned into energy more readily than saturated fats. These results may mean that if one feeds more monounsaturated fatty acids (MUFA) and less saturated fatty acids (SFA) in the diet, body fat might accumulate at a lower rate. This could affect the risk of obesity and Type 2 Diabetes. This project has two principal Specific Aims which will be assessed in healthy young adults who are fed liquid formulas containing either an approximately equal amount of MUFA and SFA (controls) or a much greater amount of MUFA and much less SFA: 1. To determine if a higher intake of MUFA and a reciprocally lower intake of SFA is associated with a higher rate of fat oxidation. We hypothesize that the rate of fat oxidation after eating will be higher in those subjects randomized to the MUFA-enriched diet compared to controls. 2. To measure energy intake required to maintain constant body weight during each diet and to measure fat-free mass and fat mass, before and after each dietary change. We hypothesize that those on the high MUFA diet will need a higher energy intake required to maintain constant body weight.

COMPLETED
Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation
Description

The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation.

Conditions
COMPLETED
Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
Description

The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication. Some studies show that CLA can modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.

RECRUITING
Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ
Description

Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool.

COMPLETED
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib
Description

An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.

COMPLETED
Lean and Obese: Dietary Inflammation
Description

In the Lean and Obese Dietary Inflammation (LODI) study, the primary goal is to determine the effect of short-term intake of high dietary fat (5 days) compared to low fat intake (5 days) in a cross-over design in older adults (men and women) with normal body weight or obesity. Inflammation will be examined by measuring serum endotoxin and other markers, as well as the fecal microbiota.

RECRUITING
Avocado and Postprandial Responses
Description

The purpose of this study is to see how adding avocado to a breakfast meal affects blood sugar control and signals of hunger and fullness after eating. The investigators will test the effects of 3 breakfast meals on blood sugar control and signals of hunger and fullness after eating: 1. Whole-wheat bread and strawberry jam 2. Whole-wheat bread, strawberry jam, and avocado 3. Whole-wheat bread and strawberry jam (meal enriched with fat and fiber to mimic that of an avocado) Participants will undergo 3 test periods, each separated by a week. Each test period consists of one day with set meals that the investigators will provide (breakfast, lunch, and dinner), and then the next morning, participants will eat a breakfast meal and have blood drawn several times over 4 hours.

COMPLETED
A Nutrition Intervention for Arthritis -3 (WCCR-ARTH3)
Description

The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a low-fat, vegan diet improves pain and other subjective symptoms more effectively than a control supplement or a placebo. The principal measure is pain as measured by Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and tender joints, respectively. The study duration is 36 weeks. This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

UNKNOWN
Dietary Lipid Induced Insulin Resistance
Description

The overall goal of the proposal is to use a saturated fatty acid (SFA)- enriched, high fat diet to rapidly induce insulin resistance (IR) to provide insight into underlying proximal mechanisms of reduced insulin signaling. Specifically, investigators will identify the initial changes in metabolite concentrations/or pathway signaling ("pathways" will be used to broadly refer to these mechanism specific measures) and therefore the mechanisms most likely responsible for the development of IR during this high fat nutritional challenge. Investigators have assembled a multidisciplinary team that is versed with dietary studies, fatty acid metabolism, measurement of IR and potential mechanisms and mediators of IR, and has experience working with monocytes and the two tissues, muscle and adipose tissue, that are particularly relevant for understanding the effects of high fat diets on IR.

SUSPENDED
A Nutritional Intervention in Police Officers
Description

The proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.

COMPLETED
Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring
Description

The rapidly rising risk of gestational diabetes pregnant women demands that an effective diet strategy be developed due to the high risk of fetal overgrowth, which places the newborn at increased risk for childhood obesity and metabolic syndrome. The aims of this randomized clinical trial are to compare the effects of an 8-wk isocaloric higher complex carbohydrate/lower fat diet vs. a conventional lower carbohydrate (higher fat) diet on glycemic and lipid profiles, maternal insulin resistance, placenta nutrient transporters, the maternal microbiome, neonatal intrahepatic fat, and neonatal total adiposity (primary outcome). The investigators will then follow the infants for 1-yr and measure maternal breast milk and infant microbiome composition to observe if they impact net fat mass gain differently in infants exposed to one diet vs. the other. Identifying a diet for gestational diabetes mellitus women that can effectively alter maternal/fetal metabolism is critical to reducing short- and long-term metabolic risk in this growing cohort of mothers and infants and has the potential to be applicable to overweight/obese pregnant women.

SUSPENDED
Plant-Based Dietary Intervention in Type 2 Diabetes-2
Description

The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.

COMPLETED
A Nutrition Intervention for Arthritis -2
Description

The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a low-fat, vegan diet improves pain and other subjective symptoms more effectively than a control supplement or a placebo. The principal measure is pain as measured by Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and tender joints, respectively. The study duration is 36 weeks. This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

COMPLETED
Practice Based Nutrition Intervention-2
Description

This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes. The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.

COMPLETED
A Nutritional Intervention for Migraines
Description

The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.

Conditions