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Suggestions within category "Food & Nutrition"


4 Study Matches

Interventions for Patients With Alzheimer's Disease and Dysphagia

The overall purpose of this project is to develop effective dysphagia rehabilitative interventions for patients with Alzheimer's Disease and related dementias at risk for pneumonia development.
Nicole Pulia, PhD, CCC-SLP
All
50 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03682081
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Inclusion criteria (patients):
• Age 50-99
• English speaking
• Diagnosis of dementia or cognitive impairment or memory loss
• Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
• Actively involved caregiver
• Resides at home or an assisted living facility Inclusion criteria (caregivers)
• English speaking
• Age 18 and older
• Contact with patient at least 1 time a week
• Has access to a working telephone Exclusion criteria (patients):
• Dementia due to cerebrovascular disease as primary cause
• History of head and neck cancer or other structural deformity that can affect swallowing
• Allergy to barium
• Currently breastfeed or pregnant or planning to become pregnant Exclusion criteria (caregivers):
• Lacks ability to give consent
Dementia, Dysphagia, Alzheimer Disease, Dementia in other diseases classified elsewhere, Unspecified dementia, Alzheimer's disease, Mild Cognitive Impairment, Aphagia and dysphagia, Aging & Geriatrics, Food & Nutrition
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Peripheral Vasodilation in Obese Humans (ObeseDilate)

The growing population of obese adults is predicted to create a large public health burden in the next few decades. This study examines function of small blood vessels providing blood flow to skeletal muscles, to test if younger obese individuals (≤40 years old, BMI >30) are already displaying reductions in blood vessel function. This study will test if the signals blood vessels use to increase blood flow are changing in these same subjects. Findings from this study may help create treatments to delay or prevent some of the negative effects of obesity on vascular health.
William Schrage, PhD
All
18 Years to 40 Years old
Phase 1
This study is also accepting healthy volunteers
NCT02833207
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Inclusion Criteria:

• Age: ≥18
•≤ 40 years of age
• Blood pressure systolic ≤125 and diastolic ≤85 mmHg (Lean control) and <140 and diastolic <90 mmHg (Obese subjects)
• BMI <25 kg/m2 (Lean control) and ≥30 kg/m2 (Obese subjects)
• Fasting blood glucose <100 mg/dL
• Fasting LDL <130 mg/dL
• Fasting blood triglycerides <150 mg/dL
• Females: Premenopausal with a regular menstrual cycle. Negative pregnancy test. Note: Must be studied in the early follicular phase (day 1-5) of their menstrual cycle or the low hormone phase of oral contraceptive use.
Exclusion Criteria:

• Specific to obese subjects only (to exclude obese subjects with metabolic syndrome): a. If Systolic BP 130 ≤ BP < 140 mmHg or Diastolic BP 85 ≤ BP < 90 mmHg i. HDL < 40 mg/dL for men ii. HDL < 50 mg/dL for women
• Increased risk of bleeding
• Sensitivity to lidocaine
• Procoagulant or other clotting disorders
• Taking cardiovascular medications (anti-hypertensives, statins, platelet inhibitors, etc.) or metabolic medications (insulin-sensitizing)
• Regularly (≥5 days/week) take acetylsalicylic acid and/or non-steroidal anti-inflammatory drugs (NSAIDs)
• Self-reported current diagnosis of exhibiting obstructive sleep apnea
• Self-reported current or past diagnosis of diabetes
• Self-reported history of peripheral vascular disease
• Self-reported history of hepatic disease
• Self-reported history of renal disease
• Self-reported history of hematologic disease
• Self-reported history of stroke
• Current use of tobacco (i.e. smoke, smokeless, and vapor). Prior tobacco use with >1 year abstaining is allowed.
• Participation in vigorous aerobic exercise >90 minutes per week
• Arterial structures in the arm that are not conducive to study in the laboratory setting
• Females: Self-reported pregnancy and/or breastfeeding, diagnosed with polycystic ovarian syndrome, or without regular menses. Urine pregnancy test will be performed on study day to ensure subject is not pregnant on study day.
• An abnormality or contraindication to study participation which is not covered in the eligibility criteria.
Obesity, Obesity, unspecified, Healthy Volunteers
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Systems Biology of Early Atopy (SUNBEAM)

The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: - To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years, with an emphasis on atopic dermatitis and food allergy - To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes - To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development
James Gern
All
Not specified
NA
This study is also accepting healthy volunteers
NCT04798079
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Inclusion Criteria:
Pregnant Women- Pregnant women who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent 3. Pregnant at any stage 4. Planning to give birth at a study-site designated center 5. Agrees to enroll offspring into the study at birth 6. In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order Biological Fathers- Biological fathers who meet all of the following criteria are eligible for enrollment as study participants: 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
Exclusion Criteria:
Pregnant Women- Pregnant women who meet any of these criteria are not eligible for enrollment: 1. Inability or unwillingness to comply with study protocol 2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment 3. Fetus has a major chromosomal anomaly 4. Plans to move and would not be available for in-person visits at a study site 5. Plans to give up her child for adoption at birth 6. Pregnancy is the result of an egg donation Infants- Infants who meet any of these criteria are not eligible for enrollment: 1. Delivered earlier than 34 weeks of gestation 2. Sibling already enrolled 3. Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest Biological Father- 1. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment ----Note Regarding Legal Guardians who are not the Biological Parents: 1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment 2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian:
• Agrees to meet the child's study requirements, and
• Provides written informed consent for the child's continued participation. 3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures
Allergic Diseases, Food Allergy, Atopic Dermatitis, Healthy Volunteers, Food & Nutrition, Infections, Immune System & Allergies
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Dyslipidemia of Obesity Intervention in Teens (DO IT!)

This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.
Amy Peterson
All
10 Years to 19 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02956590
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Inclusion Criteria:

• Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
• BMI ≥85th percentile (using CDC BMI charts)
• Fasting lipid profile x2 each with all of the following:
• LDL-C <160 mg/dL and ≥90 mg/dL, and
• TG <500 mg/dL, and
• TG/HDL-C ratio ≥2.5 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls, and
• non-HDL-C ≥120 mg/dL
• Participant consent, or parental/guardian consent and participant assent
Exclusion Criteria:

• Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
• Known allergy or hypersensitivity to statin
• Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
• Female who is pregnant, plans to become pregnant or is sexually active without contraception
• Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants <13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
• Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
• Use of insulin sensitizing therapy
• Known renal insufficiency (known chronic renal disease, estimated GFR <60 mL/min/1.73m2 at screening)
• Uncontrolled thyroid disease (TSH at screening >1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
• Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
• Syndromic patients or patients with neurocognitive delay precluding adherence with study drug
• Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or suggested by alanine aminotransferase (ALT) ≥ 40 U/L, or severe NAFLD indicated by ALT ≥ 200 U/L
• Unexplained persistent elevated creatine kinase (CK) level >3x upper limit of normal
• Plans to leave the geographic area before completion of the anticipated 2 years of trial participation
• Any unstable medical or emotional condition or chronic disease that would preclude following the protocol or impact valid vascular measurement
• Admits to current smoking, current alcohol consumption
Dyslipidemia, Obesity, Obesity, unspecified, Heart & Vascular, Children's & Adolescent Health, Diabetes, Metabolism & Hormones
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