Treatment Trials

46 Clinical Trials for Various Conditions

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RECRUITING
Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes
Description

The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower glycemic index.

COMPLETED
Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes
Description

The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (muscle mass, strength, and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures. Study Aims. Specific aims and their respective approach for the proposed investigation were: Aim 1: Characterize energy status and protein intake in total hip arthroplasty and total knee arthroplasty patients prior to surgery. Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery. Aim 2: Evaluate association between energy status, positive or negative energy balance on standard outcome measures assessed throughout physical rehabilitation to determine whether energy status and protein intake at admission predicts objective and subjective rehabilitative outcome measures. Dietary assessments (3-day food record, protein screener) occurred at time points corresponding to physical rehabilitative assessments per approach for Aim 1. Approach. Total Hip Replacement assessments will occur between Day 1 following surgery and Week 2 and 6 months post surgery . Outcome measures included Pain Visual Analog Scale, Hip Disability Osteoarthritis Outcome Score, Timed Up and Go Test, 30 second Sit to Stand Test, Passive Hip Range of Motion and Active Hip Range of Motion. Total knee assessments were taken post surgery on between Day 1 and Week 2 and at 4 to 6 Weeks, and 7 to 12 Weeks following surgery. These included Pain Visual Analog Scale, Knee Injury and Osteoarthritis Outcome Score, Timed Up and Go test, 30-second Sit to Stand Test, Passive and Active Knee Range of Motion, and Knee Strength. Aim 3: Validate a protein screener developed by our research team and designed to characterize protein intake and protein source was administered pre- and post-operatively. For the latter, time points were established according to respective treatment guidelines for Total Hip and Total Knee replacement patients, respectively.

COMPLETED
Molecular Mechanisms Underlying Anabolic Resistance to Protein Intake During Muscle Disuse
Description

This study will characterize intramuscular molecular mechanisms underlying anabolic resistance to protein ingestion during muscle disuse. Adults (n=12) will be studied using a unilateral leg immobilization model in which one leg will be randomly assigned to immobilization and the contralateral, active leg used as a within-subjects control. Immobilization will be implemented for five days using a rigid knee brace, during which time participants will ambulate using crutches. Integrated ribonucleic acid (RNA) synthesis will be determined during immobilization in the immobilized and non-immobilized legs using ingested deuterium oxide, salivary and blood sampling, and muscle biopsies. Immediately after immobilization, muscle biopsies will be collected before and 90 mins after consuming 25 g of whey protein from the immobilized and non-immobilized legs to characterize the intramuscular molecular response to protein feeding. Serial blood samples will be collected during that time to characterize the circulating metabolic response to protein ingestion. Knowledge generated from this effort will inform the development of targeted interventions for mitigating anabolic resistance to protein ingestion that develops during periods of muscle disuse.

COMPLETED
The Effect of Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
Description

Aging is associated with a decline in muscle mass, strength, and physical function, leading to sarcopenia and frailty. This deterioration of muscle and physical capabilities impacts an individual's functional independence and quality of life. Dietary protein stimulates muscle protein synthesis. Therefore, nutritional interventions that recommend higher protein intakes may enhance muscle protein synthesis. Food intake, including protein-rich foods such as red meat, has been shown to decline with age. Barriers to consuming protein-rich foods include reductions in taste and smell, dentition and dexterity, and changes in living situations. Therefore, nutritional interventions that can effectively improve eating behaviors and diet quality while stimulating muscle protein synthesis in older adults are necessary to help prevent, manage, and promote recovery of sarcopenia. To reduce potential barriers of red meat consumption in community-dwelling older adults, an additional beneficial strategy may be the use of cooking demonstrations, or culinary medicine, by imparting knowledge about healthy cooking to improve the dietary habits of individuals who are at risk of sarcopenia. In this approach, people will be educated about age-appropriate, healthy eating behaviors and equipped with basic cooking skills to incorporate nutritious food into their daily diet. A systematic review concluded that culinary interventions such as cooking classes effectively improved attitudes, self-efficacy, and healthy eating in children and adults. A recent study using cooking videos to encourage the consumption of calcium-rich foods showed that the subjects gained knowledge and were motivated to consume calcium-rich foods, and video demonstrations were accepted as an effective communication channel to impart cooking skills. Additionally, it is suggested that cooking at home improves adherence to healthy nutrition, thereby reducing chronic illness risks. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Thus, cooking demonstrations can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. Culinary medicine is an evidence-based field that combines skills of preparing, cooking, and presenting food with the science of medicine to accomplish potential improvements in eating behaviors and health outcomes. The goal of culinary medicine is to help people improve their diet quality which assists them in their medical regimen to produce an effective treatment.

Conditions
COMPLETED
Culinary Medicine to Enhance Protein Intake on Muscle Quality in Older Adults
Description

Aging is associated with a decline in muscle mass, strength, and physical function, leading to muscle mass loss and weakness. These concerns can impact an individual's functional independence and quality of life (QOL). Dietary protein stimulates muscle protein growth. Current studies suggest that optimal protein intake for older adults is greater than the Recommended Dietary Allowance. Barriers to consuming protein-rich foods in older adults include reductions in taste and smell, dentition, dexterity, and changes in living situation. Therefore, nutritional interventions are needed to effectively improve eating behaviors, diet quality, and stimulate muscle growth and strength. These interventions will help prevent, manage, and promote muscle mass loss recovery. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Cooking demonstrations, or culinary medicine (CM), can help teach healthy cooking to reduce potential red meat consumption barriers and improve community-dwelling older adults' dietary habits. Thus, CM can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. CM is an evidenced-base field that combines skills of preparing, cooking, and presenting food with the science of medicine. This field can help to accomplish potential eating behaviors and health outcome improvements. A tailored CM program can be an effective strategy that could reduce barriers in protein intake that will enable older adults to age well and productively.

Conditions
COMPLETED
Improving Protein Intake in Older Adults
Description

To evaluate whether or not high quality protein intake from a mixed meal can be increased by using culinary herbs and spices to increase flavor intensity and food item liking in older adults.

UNKNOWN
Effects of Graded Protein Intake on Body Composition in Older Adults
Description

This clinical trial is intended to evaluate the effects of protein intake graded to resistance training volume over a 10-week period on macroscopic skeletal muscle adaptations and body composition. Briefly, all participants will complete a progressive resistance training protocol for 10 weeks, with one group consuming a constant amount of total daily protein (RDA of 0.8g/kg/day) to serve as an active comparator. The alternative group will consume total daily protein and protein supplement in a graded manner designed to increase as overall training volume increases. Protein intake and resistance training protocols are described in full elsewhere. The investigators hypothesize that the graded protein intake group will see larger benefits to skeletal muscle function, size, and body composition than the active comparator.

Conditions
COMPLETED
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Description

A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns.

Conditions
COMPLETED
Improving Diet Protein Intake in Middle-aged Women
Description

The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Conditions
COMPLETED
Effect of Protein Intake on Post Prandial Hyperglycemia in Children and Adolescents With Type1 Diabetes Mellitus
Description

In type 1 Diabetes Mellitus, patients receive insulin doses if they consume specific amounts of carbohydrates. Currently, insulin is not being administered for consumption of protein although studies in adults show that consuming about 75 grams of protein causes elevation in post prandial glucose levels and might need insulin coverage. We are proposing that this amount is different for kids and it might vary based on weight, age, pubertal stage, HbA1C or other factors. This has not been studied in children before, and it will provide information about the amount of protein in the diet that can cause elevation in post prandial glucose.

COMPLETED
Improving Dietary Protein Intake in Adults
Description

A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.

Conditions
COMPLETED
Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
Description

The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.

COMPLETED
Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity
Description

The purpose of this study is to determine if an increased protein intake can attenuate the suppression of metabolic and anabolic hormones during caloric restriction

ACTIVE_NOT_RECRUITING
Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack
Description

The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

Conditions
COMPLETED
Effect of Protein Intake on Preterm Infant Body Composition
Description

The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

COMPLETED
Nighttime Protein Intake on Overnight Lipolysis and Morning Fat Oxidation in Obese Men
Description

Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be measured with the microdialysis technique by measuring glycerol concentration and blood flow in abdominal adipose tissue. Morning fat oxidation will be measured with indirect calorimetry. The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize that casein and placebo will not be significantly different from each other in terms of overnight lipolysis.

Conditions
COMPLETED
Protein Intake & Insulin Action
Description

The purpose of this proposal is to determine whether dietary protein restriction has beneficial effects on skeletal muscle insulin sensitivity and β-cell function in obese men and women.

Conditions
COMPLETED
Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study
Description

Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity epidemic. Increased dietary protein is one effective strategy. For example, increased whey protein ingestion with and without exercise training is associated with enhanced weight loss, body composition and subjective hunger in overweight and obese individuals. Our findings suggest that the effects of whey protein ingestion occur independent of a calorie-restricted diet and to a greater extent in individuals following a combined exercise program of resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training compared to standard resistance training.

COMPLETED
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
Description

The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

Conditions
COMPLETED
High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor
Description

The purpose of our study is to determine if the incidence of emesis can be lowered with the addition of a high protein drink during labor. Emesis and nausea are the leading causes of parturient dissatisfaction, results in a delay of returning to normal, daily living and can hugely impact the mother's postpartum experience. To date, no studies have been done on the relationship of protein intake during labor and incidence of emesis. To the best of our knowledge, the use of a high protein drink during labor has not been evaluated in the literature.

Conditions
COMPLETED
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
Description

This study is designed to assess the effect of a diet-controlled nutrition program utilizing an egg-based higher protein diet on muscle composition and size, and indices of metabolic health and markers of systemic inflammation in older men and women who are slightly overweight.

COMPLETED
Optimizing Protein Intake in Older Americans With Mobility Limitations
Description

This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake. The study will have a 2 X 2 factorial design, which will allow us to investigate the effects of dietary protein intake and testosterone separately and together.

COMPLETED
Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss
Description

The primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.

COMPLETED
The Effect of Weight Loss and Dietary Protein Intake on Bone
Description

The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health. We will also examine how two levels of protein intake affects diet quality.

TERMINATED
The Effect of Severe Weight Loss and Protein Intake on Bone
Description

The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.

Conditions
COMPLETED
The Effects of Obesity and Protein Intake on the Kidney
Description

The purpose of this study is to determine if being overweight and eating lots of protein causes separate changes in the kidney that lead to kidney disease over time. These questions are important because the number of people who have kidney disease is quickly growing. If being overweight and eating lots of protein is found to cause kidney disease, then doctors may be able to limit the number of people with kidney disease by recommending weight loss and eating less protein

Conditions
ACTIVE_NOT_RECRUITING
Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics
Description

This study will examine the effects of protein (whey) supplementation added to the normal diet of pre-diabetes or diagnosed type 2 diabetes mellitus (T2DM) men and women on plasma glycated hemoglobin (HbA1c) and total body fat levels. Specifically, this study will directly quantify the impact of 3x/day timed ingestion of supplemental whey protein (20 grams of 80 calories per serving) added to the normal diet of free-living pre-diabetic or T2DM men and women over an 8-week study period on the major diagnostic outcome of pre-diabetic and T2DM (HbA1c levels) and total body fat levels. This study will quantify changes in HbA1C and total body fat levels in 24 pre-diabetics or T2DM participants.

COMPLETED
Dietary Protein Requirements in Hemodialysis Patients
Description

The primary purpose of this study is to assess dietary protein requirements in clinically stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary protein intake (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.

COMPLETED
The Body's Response to Changes in Dietary Protein and Meal-Frequency In Men
Description

the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.

RECRUITING
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Description

We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.