Treatment Trials

25 Clinical Trials for Various Conditions

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COMPLETED
Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach
Description

New research suggests that about 1 in 8 children may be diagnosed with an autism spectrum disorder (ASD) in the United States. This could be due to several reasons which remain unknown. This study invites mothers who have given birth to children in the United States to share their experiences with diet and supplementation during pregnancy. The purpose of this study is to understand the role of a mother's diet, social standing, and supplementation with folate or folic acid may have on her child's future development of autism. Comparisons will be made between mothers of children who have a child with an official ASD diagnosis from a clinician to mothers of children without an ASD diagnosis. Findings from this study can be used to help identify risk factors for ASD risk.

UNKNOWN
Nutrition, Vision, and Cognition in Sport Study: Beef
Description

The purpose of this study is to determine whether a 30 day beef intervention can improve peak cognitive performance in young, normally menstruating adult women. The control group will consume a daily portion of macronutrient equivalent vegetable source of protein.

COMPLETED
BioFe, Medical Food for the Dietary Management of Iron Deficiency
Description

This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.

Conditions
COMPLETED
Effect of Iron Supplements on the Growth of Enteric Pathogens
Description

Iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. Because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. However, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from women of reproductive age following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens, and outcome measures will be determined following in vitro fecal fermentation.

COMPLETED
Diet Treatment Glucose Transporter Type 1 Deficiency (G1D)
Description

Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in addition to IQ, language, working memory, processing speed, emotional and behavioral functioning, ataxia, and other neuropsychological and neurological performance indices in children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.

COMPLETED
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency
Description

Military personnel face many physiological challenges, including sustained physical activity and prolonged periods of negative energy balance. Chronic energy deficiency often results in a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests that dietary interventions that provide protein in excess of the current national dietary recommendation may confer protection against the negative effects of energy deficiency on the musculoskeletal system. The primary objective of this randomized, controlled study is to assess the effects dietary protein intake spanning the current acceptable macronutrient distribution range on musculoskeletal health following prolonged energy deficiency. Findings from this investigation will improve current understanding of dietary conditions necessary to reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters. Furthermore, given the rise in obesity in military populations, findings may aid in the development of nutritional weight management strategies that promote healthy weight loss without compromising musculoskeletal health.

RECRUITING
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
Description

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

RECRUITING
A Natural History Study Seeks to Understand the Clinical, Genomic, Pharmacological, Laboratory, and Dietary Determinates of Pyrimidine and Purine Metabolism Disorders
Description

Background: Pyrimidine and purine metabolism disorders (DPPMs) affect how the body metabolizes chemicals called pyrimidines and purines. DPPMs can cause dysfunctions throughout the body, especially in the brain, blood, kidneys, and immune system. People with DPPMs might have no symptoms, mild symptoms, or they may have severe, chronic symptoms, that can be fatal. DPPMs are not well understood, and researchers want to learn more about what causes them and how to treat them. Objective: To learn more about factors that affect DPPMs by comparing test results from affected, uaffected family members, and healthy people. Eligibility: Three types of participants are needed: people aged 1 month and older with DPPMs; their family members who do not have DPPMs; and healthy volunteers. Design: Participants with DPPMs will come to the clinic once a year; some may be asked to come more often. At each visit, all affected participants will have a physical exam and give samples of blood, urine, saliva, and stool. Depending on their symptoms, they may also have other procedures, such as: Swabs of their skin and inside the mouth. Tests of their heart, kidney, brain, and nerve function. Questionnaires about what they eat. Dental exams, and exams of their hearing and vision. Tests of their learning ability. Monitoring of their physical activity. Imaging scans. Photographs of their face and body. These tests may be spread over up to 7 days. Affected participants may remain in the study indefinitely if they wish to. Healthy volunteers and family members will have 1 study visit. They will have a physical exam and may be asked to give blood, urine, saliva, and stool samples.

Conditions
AMPD3, OMIM*102772, AMP Deaminase DeficiencyAK1, OMIM *103000, Adenylate Kinase DeficiencyAMPD1, OMIM *102770, Myopathy Due to Myoadenylate Deaminase DeficiencyTPMT, OMIM *187680, Thoipurines, Poor Metabolism ofIMPDH1, OMIM *146690, Retinitis Pigmentosa Type 10, Leber Congenital Amauriosis Type 11APRT, OMIM *102600, Adenine Phosphoribosyltransferase DeficiencyHPRT1, OMIM *308000 Lesch-Nyhan DiseaseXDH, OMIM *607633, Xanthinuria Type 1SLC2A9, OMIM *606142 HypouricemiaSLC22A12, OMIM *607096 HypouricemiaPRPS1 Def, OMIM *311850, Arts Syndrome; Charcot-Marie-Tooth DiseasePRPS1 SA, OMIM *311850 Gout, PRPS-related Phosphoribosylpyrophosphate Synthetase SuperactivityAMPD2, OMIM *102771, Spastic Paraplegia 63; Pontocerebellar HypoplasiaITPA, OMIM *147520, Inosine Triphosphatase Deficiency; Developmental and Epileptic Encephalopathy 35ADSL, OMIM *608222, Adenylosuccinate Lyase DeficiencyPNP, OMIM *164050, Nucleoside Phosphorylase DeficiencyADA2, OMIM *607575,Sneddon Syndrome; VAIHSCAD, *1140120, Developmental and Epileptic EncephalopathyUPB1, OMIM *606673, Beta-ureidopropionase DeficiencyDPYS, OMIM *613326, Dihydropyrimidinase DeficiencyDPYD, OMIM *274270, Dihydropyrimidine Dehydrogenase DeficiencyDHODH, OMIM *126064, Miller Syndrome (Postaxial Acrofacial Dysostosis)UMPS, OMIM *613891, Orotic AciduriaNT5C3A<TAB>, OMIM *606224, Anemia, Hemolytic, Due to UMPH1 DeficiencyUNG, OMIM *191525, Hyper-IgM Syndrome 5AICDA, OMIM *605257, Immunodeficiency With Hyper-IgM, Type 2; HIGM2Purine-Pyrimidine MetabolismMetabolic Disease
RECRUITING
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
Description

The objective of the current study is to test the overarching hypothesis that the beef nutritive matrix is uniquely suited to direct dietary zinc to cellular compartments for improved metabolic function, leading to a greater effect on health outcomes. Specifically, whether beef, as a component of a healthy meal, will promote the absorption of zinc into cells, where the zinc will have greater effects on zinc-dependent metabolic processes supporting cardiovascular health. To maximize the observability of these beef-related effects, individuals who are 55- to 70-year-old who generally have a higher risk of zinc deficiency and cardiovascular disease will be enrolled.

COMPLETED
Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes
Description

The study team will examine the effect of a ketogenic diet alone and ketogenic diet supplemented with oral ketones on how the body of individuals with type 2 diabetes respond to insulin, regulates insulin secretion, food intake and energetic pathways and influences body fat distribution.

COMPLETED
Habitual Diet and Avocado Trial
Description

The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per day for recommended consumption over a 6 month period in a cohort of approximately 1000 free-living participants with increased waist circumference in comparison with a control group that will maintain their habitual diets. Participants will be recruited and screened at 4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and Tufts University (250 per site).

COMPLETED
Effects of a 10 Component Dietary Supplement on Health and the Quality of Life
Description

This open-label field trial evaluates the effects of treatment with a multi-pathway dietary supplement (Stem Cell 100+) that has been commercially available for several years. The objective of the intervention trial is to determine if normal subjects over 35 years of age experience any observable health benefits from the dietary supplement as to their blood pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported changes in markers of overall health and life expectancy.

COMPLETED
Genetic, Dietary and Environmental Influences on Vitamin D Metabolism
Description

Determine differences in serum vitamin D metabolism by genetic ancestry.

COMPLETED
Bioavailability of Zinc and Iron From a Whey-based Protein Supplement Consumed With a Habitual Plant-based Diet
Description

Bioavailability of iron and zinc from habitual plant-based diets consumed by young children in Mexico is low due to the high phytate content. Whey protein has been found to increase zinc absorption, thus, providing a whey based supplement with micronutrients may be an effective strategy to increase iron and zinc bioavailability from plant-based foods and alleviate iron and zinc deficiencies. The investigators compared absorption of zinc and iron in children receiving diets with and without whey protein supplements (WPS).

WITHDRAWN
Neurodevelopmental Outcome of Early Dietary Lysine Restriction in Pyridoxine Dependent Epilepsy Patients
Description

Restricting dietary lysine intake in infants from age 3 months or less with confirmed diagnosis of pyridoxine-dependent epilepsy due to Antiquitin (ATQ) deficiency will: reduce the accumulation of neurotoxic substratesα-aminoadipicsemialdehydeandits cyclic equivalent 1-piperideine-6-carboxylate;and will improve overall neurodevelopmental outcome at 3 years of age by acting as an effective intervention into the complex pathophysiology of the condition.

COMPLETED
Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy
Description

The two specific aims of this study are 1) to assess the relative contributions of two major maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to the fetus, and 2) to determine the impact of maternal and fetal iron status on placental transfer of these two iron sources in pregnant women and adolescents during the last trimester of pregnancy.

Conditions
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
Effect of Calcium-fortified Cereal Bars on Dietary Calcium Intake in Women
Description

The purpose of this study is to determine whether eating Kellogg's Nutri-Grain cereal bars will increase calcium intake in healthy adult women.

TERMINATED
Dietary Cholesterol and Defects in Cholesterol Synthesis in Mevalonate Kinase Deficiency
Description

Participants wanted for study of mevalonate kinase deficiency (MKD), mevalonic aciduria, or hyperimmunoglobulinemia with periodic fever syndrome (HIDS). Patients with MKD (mevalonic aciduria or hyperimmunoglobulinemia with periodic fever syndrome (HIDS)) may be eligible for a research study conducted at Oregon Health \& Science University (OHSU) in Portland, Oregon USA. The purpose of the study is to find out more about how these diseases affect body chemistry and health. The researchers also want to find out how cholesterol in the diet affect blood cholesterol and how the body handles cholesterol. This is a short-term and long-term dietary study. The long-term goal of this research is to see if controlling dietary cholesterol can decrease any of the symptoms of the diseases. The study could involve up to 12 one-week admissions to OHSU over the course of 5 years.

COMPLETED
Effects of Dietary Carbohydrate and Fat on Hormones
Description

This study will try to determine if intake of dietary fats or carbohydrates influences the tendency to gain weight or accumulate body fat. It will examine how the hormones that regulate weight may change with a shift from a balanced diet to one that is low in fat or carbohydrate, irrespective of caloric intake. Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kg/m2 may be eligible for this study. Candidates will be screened with a history, physical examination, blood tests and questionnaires regarding activity, prior diets, and eating patterns. Participants will follow two separate diet regimens for 5 days each. The first will be a balanced diet, and the second will be either a low-fat/high-carbohydrate diet or a low-carbohydrate/high-fat diet. The diets are not designed to produce weight loss. Participants will receive all their meals and snacks for the two diets from the National Institutes of Health and, for the first 3 days of each diet, will be seen as outpatients. For days 4 and 5 of each diet, they will be admitted to the Clinical Center and will undergo the following procedures: * Blood tests - Blood samples will be collected every 30 minutes over a 24-hour period through an indwelling catheter in the arm. A total of about 15 tablespoons will be drawn for each of the two diets. * 24-hour urine collection - One 24 hour urine collection will be done at home the day before admission to the Clinical Center, and the other will be done during the hospital stay. * Urinalysis and pregnancy test - A small urine sample will be taken and women will provide an additional sample for a pregnancy test. * Body measurements - Height and weight will be measured using scales. Body fat will be measured by two methods: skin fold thickness, measured with calipers in 5 separate places; and body circumference measurements, in which body parts are measured with a tape measure. * Bod pod measurement - Proportions of fat and non-fat tissue in body weight are measured while the participant sits in a capsule-like device for 5 minutes. * Bioelectric impedance analysis - Proportions of body fat are measured based on conduction of a small electric current. * Total body water estimate -The proportion of body weight that is water is determined, using a method that involves drinking a cup of a special kind of "heavy" water (deuterium) and then measuring the amount of heavy water in a urine sample taken after 4 hours. * Exercise - Participants will maintain their usual exercise routine, as it was before beginning the study.

COMPLETED
Treatment of Calcium Deficiency in Young Women
Description

This study looks at the effects of calcium supplementation on bone density in women in their third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their diets in one of two groups. We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will monitor the results by looking at the change in bone mineral density measured at the hip, total body, forearm, and spine. Treatment will last 3 years.

Conditions
COMPLETED
Vitamin A Equivalence of Plant Carotenoids in Children
Description

Our objectives will be to test the following hypotheses and to make the following determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The absorption of provitamin A carotenes and their bioconversion to vitamin A are different in children with or without adequate vitamin A nutrition. (3) To define the vitamin A equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope reference method in children with or without adequate vitamin A nutrition and to compare those values with values derived from model based compartmental analysis. (4) To determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources.

COMPLETED
The Effects of Work Schedule and Sleep Patterns on Caregivers' Health
Description

BACKGROUND. Sleep deficiency (not getting enough sleep) is widespread in American adults and can lead to many harmful health outcomes such as a higher risk of obesity, heart disease, and diabetes. Sleep deficiency can also harm cognitive performance, which refers to one's awareness and thinking ability. Sleep deficiency and sleep-related health issues are of high interest among those who have irregular and/or extended work schedules, because such schedules can interfere with normal biological rhythms of sleepiness and wakefulness. PURPOSE. This study will examine the health and cognitive effects of work schedule and sleep patterns in caregivers (such as nurses, laboratory technicians, and non-clinical hospital staff). The investigators hypothesize that the nontraditional, irregular, and extended work hours common in these professions will have adverse health and cognitive effects. The purposes of this protocol are to: * Enroll caregivers into a one year cohort study on the relationships among work schedule, sleep, diet, chronic disease, and cognitive performance. (A cohort study follows a group of participants over time to see how different behaviors or risk factors affect health.) * Collect data from caregivers on work schedule, sleep, diet, chronic disease, and cognitive performance. * Give personalized information and feedback to caregivers about these health factors. * Educate caregivers about healthy diet and exercise choices. * Collect saliva from caregivers for future research on the role of genes in health. (Specimen collection for genetic testing will be offered as a separate option for study participants.) RECRUITMENT. This study will use the Let's Get Healthy! health research and education program (OHSU IRB #3694) as a platform for recruitment and data collection. Caregivers will be invited to participate in a Let's Get Healthy! event and will be given information prior to the event about the cohort study. At the Let's Get Healthy! event, caregivers will first consent to the anonymous research study (OHSU IRB #3694), in which demographic and health screening data are linked to a random number. Caregivers will then have the option to consent to a cohort study, in which data are no longer anonymous but instead linked to participants' names and contact information. PROCEDURES. This cohort study piggybacks on procedures already approved for the Let's Get Healthy! program (OHSU IRB #3694). Let's Get Healthy! is a study in which participants provide anonymous data at health fairs through any or all of the following manners: short computer surveys on cancer awareness, risk factors, and family history (with immediate feedback given on cancer risk and prevention); short computer surveys on diet and sleep patterns (with immediate printed feedback given); health screening measurements (blood pressure, height, weight, waist circumference, body mass index, body fat percentage); a finger stick to assess sugar and fat levels in blood; and a mouthwash swish to provide a saliva specimen. However, this cohort study (OHSU IRB #7542) will make the following changes and additions: * Personal health data, instead of being anonymous, will be linked to participants' names and contact information (for follow-up data collection). * Let's Get Healthy! events will include cognitive performance tests, a preventative-care survey, and a work schedule survey. * Participants will provide data not only at an initial Let's Get Healthy! event, but also at a follow-up event and during the time period between events. Between events, participants will do the surveys on work schedule, diet, and sleep, and they will complete cognitive performance tests. * There will be a separate consent process for participants to provide a fully identifiable saliva specimen. DATA ANALYSIS. Participants' health data will be fully identifiable at the time of data collection but will be coded and stored in a physically separate location from the identifiable information. The link between identifiable information and coded health information will be stored on a password protected computer, and all identifiable information will be deleted upon completion of data analyses. Data will be analyzed to explore relationships among work schedule, sleep, diet, body composition, metabolic health, chronic disease, and cognitive performance in caregivers. Genetic relationships with these factors will be analyzed in those who provided a saliva specimen during entry visit data collection.

COMPLETED
Vitamin D Supplementation in Older Women
Description

The purpose of this study is to examine the effects of several doses of vitamin D on hormones related to bone, calcium absorption, bone density and muscle strength.

COMPLETED
Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
Description

The purpose of this study is to determine if supplemental vitamin K will reduce age-related bone loss in elderly men and women above that achieved by supplementation.