amino acid tracer injection for metabolism analysis The dose needed to be injected from the tracer element in the beginning of the study is a bolus of 16ml Amino acid tracer (non-radioactive).
it is a single bolus, no other elements or drug will be administered.

amino acid tracer injection for metabolism analysis The dose needed to be injected from the tracer element in the beginning of the study is a bolus of 16ml Amino acid tracer (non-radioactive) it is a single bolus, no other elements or drug will be administered.

Metabolism and Nutrition Disorder

the intervention includes injecting stable amino acid tracers in order to evaluate differences in processing of amino acid in critically ill patients compared to a normal population.
after injection 5 ml of blood will be drawn at time 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes from the start of the study, a total of 14 blood samples (70 cc).

amino acid tracer injection for metabolism analysis

Rabin medical center

Amino Acid Metabolism in Fed Surgical Critically Ill Patients

Twenty Four Hours Amino Acid Metabolism in Fed Surgical Critically Ill Patients: a Stable Isotope Tracer Study.

In the study stable isotopes of amino acids will be injected, and afterward the amount of each amino acid will be checked in order to assess degradation and metabolism. Composite measure.

Pierre Singer

Professor

Rabin Medical Center

Texas A&M University

Participants consuming leucine supplementation with measures obtained from the uni-laterally immobilised leg.

Participants consuming leucine supplementation with measures obtained from the non-immobilised leg.

Participants consuming placebo supplementation with measures obtained from the uni-laterally immobilised leg.

Participants consuming placebo supplementation with measures obtained from the non-immobilised leg.

Muscle Disuse Atrophy

Participants will ingest 15g of leucine supplementation/day during the immobilisation period. Leucine supplementation will be administered in powdered form (Infinit Nutrition, Canada) and participants will be required to consume 5g of leucine mixed with 250-300 ml of water during each meal. Leucine is a dietary supplement according to the US FDA. This supplementation protocol has been demonstrated in humans (Murphy et al., 2016, AJCN) with no reported side effects. The quantity of leucine supplementation falls well within the safe limits outlined by Rasmussen et al. (2016). Infinit Nutrition Leucine is in compliance with banned substances requirements as espoused by the World Anti-Doping Agency. Infinit Nutrition Leucine is not a medicinal product.

Leucine

Participants will ingest 15g of placebo supplementation/day during the immobilisation period. Placebo supplementation will be administered in powdered form and participants will be required to consume 5g of placebo supplementation mixed with 250-300 ml of water during each meal (3x/day).
Placebo supplementation will contain 5g of non-essential amino acids (Infinit Nutrition, Canada) and will be calorically matched to the leucine supplementation.This supplementation protocol has been demonstrated previously in humans, with no reported side effects (Murphy et al., 2016, AJCN).

Placebo

University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences

Can Supplemental Leucine Offset Disuse-induced Muscle Atrophy?

The change in the lean mass of the leg muscles following the 7 day immobilisation period.

The rates of post-absorptive and post-prandial myofibrillar protein synthesis response to 20 g of milk protein after a 7 day period of disuse.

University of Birmingham

The experimental intervention is the GMP diet followed at home for 3-wk. In this randomized crossover study, half of subjects (n=15) were randomized to receive the GMP diet as the first arm, and half of the subjects (n=15) were randomized to receive the GMP diet as the second arm.

The experimental intervention is the AA diet followed at home for 3-wk. In this randomized crossover study, half of subjects (n=15) were randomized to receive the AA diet as the first arm, and half of the subjects (n=15) were randomized to receive the AA diet as the second arm.

In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.
Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home.

GMP Diet-AA Diet

In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.
Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home.

AA Diet - GMP Diet

Total

Sex: Female, Male

Region of Enrollment

Plasma will be collected at each base week and after 3 weeks on each of the dietary treatments, glycomacropeptide and amino acid, following an overnight fast. Plasma phenylalanine concentration (along with the complete profile of free amino acids) will be determined with an amino acid analyzer in the Wisconsin State Lab of Hygiene. Statistical analysis to determine the significance of the change in plasma phe concentration when comparing the 2 diets will consist of ANCOVA with covariates for baseline Phe and dietary Phe intake. The change in plasma Phe concentration from day 22 (final) to day 1 (baseline) was determined after adjusting for baseline Phe level and dietary Phe intake.

All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.

GMP Diet/GMP Medical Foods

All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.

AA Diet/AA Medical Foods

Change in the Plasma Phenylalanine Concentration of PKU Subjects Fed the Glycomacropeptide Diet Compared With the Change When Fed the Amino Acid Diet

Compliance with the glycomacropeptide and amino acid dietary treatments will be assessed by comparison of the intake of medical food in grams of protein from medical food per day based on subject completion of 3-day food records prior to the final study visit on day 22. Statistical analysis for a dietary treatment effect will consist of ANOVA.

GMP Diet

Dietary Compliance

Completion of a standardized test, the Behavior Rating Inventory of Executive Function (BRIEF), by each subject for the GMP diet and the AA diet. Values are T-scores which have a mean of 50 points and a SD of 10 points. A T score of <50 is considered within the normative range. Data are analyzed with a paired t-test.

The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made from glycomacropeptide .

The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.

Executive Function Assessed by BRIEF

Vitamin D was measured as a measure of the capacity for calcium absorption. Higher levels of plasma vitamin D are consistent with higher calcium absorption.

Vitamin D (25-OH) Plasma Concentration at Day 22

Concentrations of Phe in plasma and in dried blood spots collected simultaneously by subjects will be compared using 2 methodologies, regardless of intervention. At each of the 4 study visits (baseline and final for each dietary treatment): 1) venipuncture was used to collect blood and plasma was isolated and analyzed for Phe with ion exchange chromatography and 2) subjects were asked right after the venipuncture to spot their blood on filter paper for analysis of Phe with tandem mass spectroscopy (MS/MS). The discrepancy in Phe concentrations with these 2 methods was compared for each sample pair using Bland-Altman statistical analysis. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs, as explained below.

Blood was collected by venipuncture at 3 to 4 time points, plasma was isolated and the concentration of Phe was determined by ion exchange chromatography.

Phe Concentration in Plasma, Ion Exchange Chromatography

Subjects spotted their blood on filter paper at the same time as plasma was obtained at 3 or 4 time periods, dried blood spots were obtained, and analyzed for Phe concentration using tandem mass spectrometry.

Phe Concentration in Dried Blood Spots, Tandem Mass Spec

Comparison of Phe Concentrations in Plasma With Concentrations in Dried Blood Spots

Plasma concentration of BSAP was determined as a measure of bone turnover.

The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.

Bone-specific Alkaline Phosphatase (BSAP) Plasma Concentration at Day 22

Plasma concentration of NTX was determined as a measure of bone resorption; higher levels indicate greater bone breakdown

The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.

The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.

N-terminal Telopeptide (NTX) Plasma Concentration at Day 22

Subjects will have a single DXA test to assess bone mineral density of the lumbar spine and total body during the first dietary treatment that they are randomly assigned to start with.

Bone Mineral Density Determined by Dual-energy X-ray Absorptiometry (DXA) Scan

Intervention 1

Intervention 2

Dr. Denise M Ney

Phenylketonuria

The intervention consists of a low-phenylalanine (Phe) diet in combination with medical foods made with the peptide GMP supplemented with limiting indispensable amino acids, as provided by Cambrooke Therapeutics, LLC. The diet is formulated to replace the protein equivalents provided by AA medical foods with GMP medical foods, keeping other dietary components constant. The GMP dietary treatment period consists of all subjects following the GMP diet for 3-wks at home. The GMP diet intervention is administered in differing orders, GMP Diet/AA Diet or AA diet/GMP Diet.

The intervention consists of a low-Phe diet in combination with commercial AA medical foods as consumed in each subject's usual diet. A total of 15 different commercial AA medical foods were consumed by subjects in the study. The diet is formulated to provide each subject with their typical daily intake of protein equivalents from AA medical foods. The AA dietary treatment period consists of all subjects following the AA diet for 3-wks at home. The AA Diet comparator intervention is administered in differing orders, GMP Diet/AA Diet or AA diet/GMP Diet.

Children's Hospital of Boston

University of Wisconsin-Madison

Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria

Phase 2 Study of Glycomacropeptide vs. Amino Acid Diet for the Management of PKU

University of Wisconsin, Madison

Boston Children's Hospital

The study is a randomized, two-arm, crossover trial comparing the GMP diet and the AA diet in 30 subjects with PKU > 12 years of age. Subjects were randomized to start with either the GMP diet or the AA diet which they followed for 3-wk at home, followed by a 3-wk washout period when they resumed their usual AA diet, and then 3-wk of either the GMP diet or the AA diet whichever they did not consume first. Each subject served as their own control; there was no control group. We studied medical foods - either AA or GMP medical foods which are not drugs. The FDA did not require that we have an IND.

phenylalanine/atrophie

Amino Acid Metabolism in Fed Surgical Critically Ill Patients

Can Supplemental Leucine Offset Disuse-induced Muscle Atrophy?

Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria

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