Clinical Research Directory

Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty

The study is designed to investigate the effect of a perioperative multicomponent rehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting

This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: * Medical history, physical examination and laboratory studies * Questionnaires to assess eating behavior, food preferences, body composition, and activity level * Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) * Oral glucose tolerance test * Meal test to measure the response of certain hormones to food * Activity monitors to determine activity level * Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature * Free-living energy use study to measure calories burned under normal home conditions over 7 days * Fat and muscle biopsies * Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: * Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) * Yearly visits (2-night inpatient stay) for all participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test

Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention

This study will determine the feasibility and acceptability of a 12-week dyadic culinary nutrition program among Hispanic prostate cancer survivor/caregiver dyads using a randomized controlled trial design.

Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL

The treatment of gestational diabetes (GDM) primarily revolves around consuming an optimal diet that does not cause blood glucose levels to become excessively high and provides an adequate supply of micro- and macronutrients without resulting in excessive weight gain during pregnancy. In some cases, it may become necessary to supplement with insulin during pregnancy. However, insulin treatment is associated with personal, health-related, and healthcare cost-related implications. The rationale for this study is the lack of knowledge regarding whether the extent of support and guidance from a dietitian during pregnancy has an impact on the treatment outcomes for both the mother and the child in cases of GDM. The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with GDM randomised to either intensive dietary therapy or standard dietary care (control). The primary endpoint is the effect of intensive dietary therapy on the likelihood of remaining treated with diet only vs. needing insulin therapy. The study design is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM.

Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.

Longitudinal Randomized Controlled Study on the Effectiveness of Nutritional Education During Uncomplicated Pregnancy

The goal of this clinical trial is to evaluate whether a structured nutritional education intervention can improve gestational weight gain outcomes and related maternal and neonatal health indicators in women with uncomplicated pregnancy. The main question it aims to answer is whether a group-based nutritional education program increases the proportion of women achieving gestational weight gain within Institute of Medicine (IOM) recommended ranges compared with standard prenatal care. Researchers will compare a structured nutritional education intervention group to a control group receiving routine prenatal care and a nutritional information brochure to see if the intervention improves gestational weight gain within recommended ranges and affects maternal and neonatal outcomes. Participants in the intervention group will: * Attend three weekly group-based nutritional education sessions delivered by trained healthcare professionals * Attend one practical cooking (show-cooking) session Participants in the control group will: * Receive routine prenatal care and a written nutritional information brochure * Be followed from early pregnancy until 8 weeks postpartum All participants (including control group) will: * Record body weight regularly throughout pregnancy using a telemedicine system * Complete questionnaires on dietary intake and quality of life at multiple time points * Undergo assessments of body composition and urinary biomarkers of oxidative stress during pregnancy

Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes

The goal of this clinical trial is to examine the effect of 3 versus 6 daily meals of isocaloric diets on glycemic control and variability in individuals with type 1 diabetes. Participants will be randomized in a crossover clinical trial and will receive two different types of isocaloric diet interventions, in 3 meals/day (calorie distribution: 30% at breakfast, 40% at lunch and 30% at dinner) or 6 meals/day (calorie distribution: 20% at breakfast, 10% at morning snack, 30% at lunch, 10% at afternoon snack, 25% at dinner and 5% at evening snack), for three weeks, with a 4-week washout period between diets.

Bionenergetic Balance During CVVH

The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted. Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.