Metabolic Syndrome

Chronic Fatigue Syndrome

Premature Aging

RiaGev

Prism Research, Inc.

The Safety and Efficacy Study of RiaGev in Healthy Adults

A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Safety and Efficacy of RiaGev™ in Healthy Adults

The change in whole blood NAD+ levels from baseline to day 8 when supplemented with RiaGev™ or comparator. The parameter is measured at Day 1, Day 3, Day 5, and Day 8.

The change in serum glucose as assessed by an Oral Glucose Tolerance Test (OGTT) at t=0, 15m, 30, 45m, 60m, 90m and 2h after a 7-day supplementation with either RiaGev™ or comparator. The measure will take place on Day 1 and Day 8

The change in serum insulin as assessed by an Oral Glucose Tolerance Test (OGTT) at t=0, 15m, 30, 45m, 60m, 90m and 2h after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1 and Day 8.

The change in serum Glutathione/Glutathione disulfide (GSH/GSSG) ratio after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1 and Day 8, before and after exercise.

The change in serum adenosine triphosphate/ adenosine monophosphate (ATP/AMP) ratio after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, Day 3, Day 5, and Day 8.

The change in salivary cortisol after a 7-day supplementation with either RiaGev™ or comparator. The measurement take place on Day 1, 3, 5, and 8.

The change in Checklist Individual Strength (CIS) Questionnaire outcome after a 7-day supplementation with either RiaGev™ or comparator. There are twenty question categorized into four categories, including fatigue, concentration, motivation, and physical activity. The total as well as category score will be reported.

Incidence of pre-emergent and post-emergent adverse events when supplemented

Clinical chemistry parameters including alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, electrolytes (Na, K, Cl), fasting glucose, and estimated glomerular filtration rate (eGFR). The number of out of norm incidence will be reported.

Hematology parameters including white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), The number of out of norm incidence will be reported

Vital signs including blood pressure (BP) and heart rate (HR) are going to be measured. Out of norm incidence will be reported.

Bioenergy Life Science, Inc.

KGK Science Inc.

University of Washington

randomized, double-blind, comparator-controlled, cross-over

Patients with oesophagogastric, hepatobiliary, and colorectal cancer for resectional surgery

Patients undergoing abdominal operation for non-inflammatory, non-cancer conditions

Rectus Muscle Quadriceps Femoris Muscle Tumour Subcutaneous fat Intra-abdominal fat Blood Urine

Cachexia

Royal Infirmary of Edinburgh

Muscle Wasting in Cancer (MWIC)

Biochemical and Functional Biomarkers of Cachexia in Cancer Patients

CT measured muscularity performed on preoperative CT scans using validated software

The soluble protein content of Rectus muscle, as measured by the bicinchoninic acid assay (BCA) method.

Time between operative intervention and patient death as recorded in clinical record

Height and weight will be measured and combined to report BMI in kg/m^2

Gait speed will be measured over a defined distance to produce a gait speed in metres per second

Quality of life will be measured using the "QLQ-C30" questionnaire

Anonymised individual participant data (IPD), including phenotypic data but not including patient identifiable data will be shared with other researchers in collaboration with our research group. Interested parties may contact the lead researcher with data requests.

University of Edinburgh

NHS Lothian

Novartis

Other: Cellulose (control): cellulose, water soluble powder, 2 g in one daily dose, during 30 days

Dietary Supplement: Glycine, water soluble powder, 7.8 g daily in one dose, during 30 days.

Dietary Supplement: Alanine, water soluble powder, 8.5 g daily in one dose, during 30 days.

Dietary Supplement: Leucine, water soluble powder, 14 g daily in one dose, during 30 days.

Dietary Supplement: Isoleucine, water soluble powder, 8.2 g daily in one dose, during 30 days.

Dietary Supplement: Valine, water soluble powder, 9 g daily in one dose, during 30 days.

Dietary Supplement: Cysteine, water soluble powder, 2.2 g daily in one dose, during 30 days.

Dietary Supplement: Arginine, water soluble powder, 10 g daily in one dose, during 30 days.

Dietary Supplement: Methionine, water soluble powder, 4 g daily in one dose, during 30 days.

Dietary Supplement: Glutamate, water soluble powder, 33 g daily in one dose, during 30 days.

Dietary Supplement: Glutamine, water soluble powder, 30 g daily in one dose, during 30 days.

Atherosclerosis

Diet Modification

Serum; Disease

Cellulose (a vegetal product, in powder form, used as dietary fiber, that is not digested or absorbed in the intestines), will be supplemented in the form of water soluble powder.

Cellulose (control)

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Glycine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Glycine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Alanine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Alanine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Leucine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Leucine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Isoleucine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Isoleucine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Valine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Valine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Cysteine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Cysteine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Arginine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Arginine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Methionine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Methionine

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Glutamate will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Glutamate

Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Glutamine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).

Glutamine

Effects of Dietary Amino Acids on Serum and Macrophage Atherogenicity

Macrophage lipids (triglycerides and cholesterol) content (μg/mg cell protein) following incubation with serum derived from the subjects.

ribose/obesity

The Safety and Efficacy Study of RiaGev in Healthy Adults

Muscle Wasting in Cancer (MWIC)

Effects of Dietary Amino Acids on Serum and Macrophage Atherogenicity

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