PKU sphere (an FSMP) as per individual requirements determined by a dietitian.

Maternal Phenylketonuria

PKU sphere is a Food for Special Medical Purposes (FSMP). This product is for use in the dietary management of phenylketonuria (PKU).
It is a powdered, low phenylalanine medical food containing a balanced mix of GMP, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and DHA.
It is available in 27g sachets providing 15g PE and contains 28mg Phe and 35g sachets providing 20g PE and contains 36mg Phe.

PKU sphere

NHS Greater Glasgow and Clyde

University College London Hospitals NHS Foundation Trust

Evaluation of PKU Sphere in Maternal PKU

An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy

Measurement of fasting phenylalanine concentrations completed once (1) to twice (2) weekly preconception (which may last for an indeterminate amount of time), twice (2) to three (3) times weekly during pregnancy and one month postpartum. Collected as dried bloodspots on Guthrie cards in the patient's own home and posted to the hospital laboratory for analysis.

Measurement of fasting tyrosine concentrations completed once (1) to twice (2) weekly preconception (which may last for an indeterminate amount of time), twice (2) to three (3) times weekly during pregnancy and one month postpartum. Collected as dried bloodspots on Guthrie cards in the patient's own home and posted to the hospital laboratory for analysis.

3-day diary recording compliance/adherence of patients to their prescribed amount of protein substitute.

Participant to report any gastrointestinal (GI) symptoms and pregnancy-associated nausea and vomiting while consuming PKU Sphere.

Standard of care data on the outcome of the pregnancy

Vitaflo International, Ltd

University College London Hospitals

Branched Chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg). one packet at 6pm and two at 9pm.

Equinitrogenous amount of lactoalbumin 2.1 grams, and equicaloric amount with 4.0 g saccharose and 3.0 g mannitol for a total of 33.6 kcal/packet.(one packet at 6pm and two at 9pm)

Liver Cirrhoses

Branched chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg).

Branched chain amino acid

an equinitrogenous amount of lactoalbumin 2.1 grams, and equicaloric amount with 4.0 g saccharose and 3.0 g mannitol for a total of 33.6 kcal/packet.(one packet at 6pm and two at 9pm)

Placebo

Dyanand Medical College and Hospital

Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis-Child C

Treatment of Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis- Child C: A Randomized Double Blind Control Trial

Change in CT Skeletal muscle index (cm2/m2) (i.e difference between the baseline and 3 month values)

3-month change in Hand Grip Strength (Kilogram) (calculated as the difference between the baseline and 3-month values obtained by Hand Grip Dynamometer)

3-month change in muscle performance assessed by change in Gait Velocity (m/min)

3-month event-free survival at 3 months (events including complications of Cirrhosis i.e. Hepatic encephalopathy, Ascites and edema, Variceal Hemorrhage, Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome)

Change in health related quality of life measure by Short Form Health Survey (SF 36) QUESTIONNAIRE

Change in muscle performance assessed by improvement in Chair Stand.

Prof. Sandeep S Sidhu

Professor

Dayanand Medical College and Hospital

Administration of an amino acid mixture consisting of 15 amino acids, (4.1g L-alanine, 2.4g glycine, 2.4g L-histidine, 6.0g L-isoleucine, 10.1g L-leucine, 6.7g L-lysine, 4.3g L-phenylalanine, 9.2g L-proline, 5.2g L-serine, 4.3g L-threonine, 5.2g L-tyrosine, 6.7g L-valine, 3.7g L-argine, 2.0g L-cysteine, 3.0g L-methionine) lacking tryptophan to investigate the effect of tryptophan depletion on esophageal sensitivity

Administration of an amino acid mixture consisting of 15 amino acids, (4.1g L-alanine, 2.4g glycine, 2.4g L-histidine, 6.0g L-isoleucine, 10.1g L-leucine, 6.7g L-lysine, 4.3g L-phenylalanine, 9.2g L-proline, 5.2g L-serine, 4.3g L-threonine, 5.2g L-tyrosine, 6.7g L-valine, 3.7g L-argine, 2.0g L-cysteine, 3.0g L-methionine and 3.0g L-trypyophan). Since this amino-acid mixture contains tryptophan it is used as the placebo arm of this cross-over study

Esophageal Sensitivity

an amino-acid mixture will be administered without tryptophan (active comparator). After an incubation period of 5 hours esophageal sensitivity will be assessed by multimodal stimulation to evaluate the effect of depleted tryptophan levels on esophageal sensitivity

Acute tryptophan depletion

an amino-acid mixture with tryptophan (placebo mixture) will be administered. After an incubation period of 5 hours esophageal sensitivity will be assessed by multimodal stimulation

The multimodal esophageal probe allows to perform 4 types of stimulations in the esophagus (thermal, mechanical, electrical and chemical stimulation). These 4 modalities will be evaluated to assess esophageal sensitivity.

Multimodal stimulation probe

Targid, KU Leuven

The Effect of Acute Tryptophan Depletion (ATD) on Esophageal Sensitivity in Healthy Volunteers

The Effect of Acute Tryptophan Depletion (ATD) on Esophageal Sensitivity in Healthy Volunteers: a Randomized, Single-blind, Placebo-controlled Study

Investigation of the effect of acute tryptophan depletion on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the Temperature values (°C) of the stimulation tests between the placebo and acute tryptophan depletion condition to see if tryptophan depletion affects the sensitivity to increasing temperature.

Investigation of the effect of acute tryptophan depletion on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the balloon volumes (volume in ml) of the stimulation tests between the placebo and acute tryptophan depletion condition to see if tryptophan depletion affects the sensitivity to increasing balloon volume.

Investigation of the effect of acute tryptophan depletion on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the tolerated intensity of the electrical pulses (mA) of the stimulation tests between the placebo and acute tryptophan depletion condition to see if tryptophan depletion affects the sensitivity to increasing electrical pulses.

Investigation of the effect of acute tryptophan depletion on esophageal sensitivity to multimodal stimulation in a group of healthy volunteers. This will be assessed by comparing the volume of infused acid (ml) of the stimulation tests between the placebo and acute tryptophan depletion condition to see if tryptophan depletion affects the sensitivity to acid infusion.

Universitaire Ziekenhuizen Leuven

In this group, the patients received 100mg ferrous succinate and 200mg vitamin C three times per day for 3-4 months

In this group, the patients received 100mg ferrous succinate three times per day for 3-4 months

In this group, the patients received 200mg ferrous succinate three times per day for 3-4 months

Anemia, Iron-Deficiency

As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time

ferrous succinate and vitamin C

As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice

ferrous succinate

As another active comparator, patients take the tablets of ferrous succinate with double dosage

Hushan Hospital

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

The Efficacy and Safety of Vitamin C for Iron Supplementation Therapy in Adult Patients With Iron Deficiency Anemia(IDA)

The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the second week

The increased levels of reticulocyte after receiving three different treatment regimens are evaluated in the second week

The increased levels of hemoglobin after receiving three different treatment regimens are evaluated in the fourth week

The increased levels of ferritin after receiving three different treatment regimens are evaluated in the eighth week

The incidence of adverse events every two weeks are assessed, the adverse events include bellyache, diarrhea, constipation, vomiting, nausea.

phenylalanine/illamående

Evaluation of PKU Sphere in Maternal PKU

Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients With Liver Cirrhosis-Child C

The Effect of Acute Tryptophan Depletion (ATD) on Esophageal Sensitivity in Healthy Volunteers

the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients

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