Supplementation of spermidine at 40 mg/day has minimal effects on circulating polyamines: An exploratory double-blind randomized controlled trial in older men.

This study represents the first investigation into the safety of a novel, high-purity spermidine trihydrochloride supplement (hpSPD) in humans. Spermidine, a natural compound found in various foods, has demonstrated potential health benefits in animal and epidemiological studies. However, evidence from clinical trials and safety evaluations of spermidine supplements is limited because pure spermidine for human administration has not been available.

A toxicological assessment of spermidine trihydrochloride produced using an engineered strain of Saccharomyces cerevisiae.

Spermidine is a polyamine consumed in the diet, endogenously biosynthesized in most cells, and produced by the intestinal microbiome. A variety of foods contribute to intake of spermidine along with other polyamines. Spermidine trihydrochloride (spermidine-3HCl) of high purity can be produced using an engineered strain of Saccharomyces cerevisiae.

Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus. Multicenter Insulin Lispro Study Group.

Background: Insulin lispro is an insulin analog that was recently developed particularly for a mealtime therapy. It has a fast absorption rate and short duration of action. The efficacy of insulin lispro in the clinical therapy of patients with non-insulin-dependent diabetes mellitus (NIDDM) has not been tested.

Validity of a short form of the category test in relation to age, education, and gender.

Data for 289 subjects participating in an ongoing study of neuropsychological test performance were used to evaluate the relationship between age and prediction of performance on the long form of the Halstead-Reitan Category Test (CAT) from a short form developed by Calsyn, O'Leary, and Chaney (1980). The major questions were whether: (a) age, education, or gender would add to prediction of long (Y) from short form scores (X); (b) regression equations would be different for older and younger groups; (c) percent variance accounted for in long form scores by short form scores would be larger for younger as opposed to older subjects. For these relatively healthy subjects, prediction based on the short form was not enhanced in a clinically significantly manner by adding age, education, and gender as predictors.

Clinical efficacy and design changes of "fine bore" nasogastric feeding tubes: a seven-year experience involving 809 intubations in 403 patients.

We report here our clinical experiences of "fine bore" nasogastric feeding tubes. Data have been collated over a 7-year period (1978-1985). A total of 403 patients were intubated on 809 occasions.

Nocturnal doses of ranitidine and nizatidine do not affect the disposition of diazepam.

The disposition of diazepam (D) after a single oral dose of 10 mg was evaluated in nine healthy male volunteers under the following conditions (randomized, double-blind, crossover design): D + comedication of placebo and D + nocturnal dosing with 300 mg ranitidine or 300 mg nizatidine. Plasma concentrations of D and its major active metabolite, desmethyldiazepam (DD), were monitored by a gas-liquid chromatography-electron-capture detection assay for 84 hours. Neither ranitidine nor nizatidine had any significant effect on the hepatic elimination of D as characterized by its terminal half-life (mean +/- SD) of 35.

Effect of peptide chain length on absorption of egg protein hydrolysates in the normal human jejunum.

The influence of the peptide chain length of partial enzymic hydrolysates of protein on nitrogen and amino acid absorption was studied in 12 subjects using a jejunal perfusion technique. Three hydrolysates of egg white and an equivalent amino acid mixture were perfused at 30 mmol/L and 100 mmol/L in two separate experiments. Two hydrolysates (OH1 and OH2) contained mainly dipeptides and tripeptides, whereas the third (OH3) comprised tripeptide to pentapeptides as judged chromatographically.

Nizatidine versus ranitidine in the prevention of duodenal ulcer relapse. Six-month interim results of a European multicentre study.

Nizatidine, a new H2-receptor antagonist, was compared with ranitidine in a double-blind, randomized, multicentre trial for the prevention of duodenal ulcer relapse. This is the interim analysis of 197 patients admitted to the study by 1 September 1985, having finished a 6-month treatment period by 1 March 1986. At night, 96 and 101 patients received 150 mg nizatidine and 150 mg ranitidine, respectively.

Nizatidine versus ranitidine in gastric ulcer disease. A European multicentre trial.

Two hundred and seventy five patients from six countries were randomized into an endoscopically controlled, eight-week, double-blind, study. The objective of this investigation was to compare the efficacy and safety of nizatidine, administered as either a single (300 mg nocte) or twice daily (150 mg B.D.

300 mg nizatidine at night versus 300 mg ranitidine at night in patients with duodenal ulcer. A multicentre trial in Europe.

Patients (859) from six countries were randomized into an endoscopically controlled double-blind trial. The objective of this study was to compare the efficacy and safety of nizatidine 300 mg nocte with ranitidine 300 mg nocte in the therapy of duodenal ulceration. Patients fulfilling the entry criteria and completing the protocol numbered 777 (388 nizatidine, 389 ranitidine).

The 24-hour acid suppression profile of nizatidine.

To determine the antisecretory potency of bedtime doses of the new thiazole H2-receptor antagonist nizatidine in the suppression of nocturnal acid secretion, this randomized, cross-over, single-blind study was performed in 10 healthy male subjects. The actions of a single bedtime (2100 h) dose of the H2-receptor antagonist nizatidine (150 mg and 300 mg), ranitidine (300 mg), cimetidine (800 mg), and famotidine (40 mg), as well as placebo on nocturnal gastric acid and volume secretion (2400 to 0600 h) and on overall 24 h H+-ion concentration were studied. Compared with placebo, night-time (2300 to 0700 h) H+ ion concentration was reduced by 70, 79, 95, 75, and 89% (p less than 0.

Nocturnal acid suppression with a new H2 receptor antagonist--nizatidine.

To determine the potential efficacy of bedtime doses of the new furan H2 receptor antagonist nizatidine in the suppression of nocturnal acid secretion, this randomized, crossover, single-blind study was performed in 10 healthy male subjects. The actions of a single bedtime (21:00 hour) dose of the H2 receptor antagonists nizatidine (150 mg and 300 mg), ranitidine (300 mg) and cimetidine (800 mg), as well as placebo on nocturnal gastric acid and volume secretion (01:00 to 07:00 hours, and on overall 24 hour H+ ion concentration were studied. Compared with placebo, night-time (23:00 to 07:00 hours) H+ ion concentration was reduced by 70, 79, 95, and 76% (p less than 0.

Effect of peptide chain length on amino acid and nitrogen absorption from two lactalbumin hydrolysates in the normal human jejunum.

A double lumen jejunal perfusion technique has been used in man to study the effect of peptide chain length on absorption of amino acid nitrogen from two partial enzymic hydrolysates of lactalbumin. Copper-chelation chromatography showed that one lactalbumin hydrolysate (LH2) contained 98% peptides with a chain length greater than 4, whilst the other (LH1) contained a more even spread of chain lengths with 55% less than 4. Absorption of total nitrogen and of 14 amino acid residues occurred to a significantly greater extent from the low molecular weight LH1 than from the higher molecular weight LH2.

Elemental diet administered nasogastrically without starter regimens to patients with inflammatory bowel disease.

The present study questions the concept of routinely using 'starter regimens' at the outset of enteral feeding with chemically defined elemental diets. A hypertonic elemental diet with an osmolality of 630 mOsm/kg was administered by 24-hr nasogastric infusion to 12 patients with exacerbations of inflammatory bowel disease and to two patients with short bowel syndrome. Starter regimens were not used.

Influence of protein composition and hydrolysis method on intestinal absorption of protein in man.

An intestinal perfusion technique has been used in normal human subjects to investigate the influence that starter protein composition and hydrolysis procedure have on absorption of amino acid residues from partial enzymic hydrolysates of whole protein. Five starter proteins were studied. Three (egg albumin, casein/soy/lactalbumin, and lactalbumin) were hydrolysed by papain, a second lactalbumin starter protein, and a meat/soy/lactalbumin blend were hydrolysed by a porcine pancreatic enzyme system.

Administration of fat emulsions with nutritional mixtures from the 3-liter delivery system in total parenteral nutrition.

A series of studies was performed to test the efficacy and safety of a parenteral lipid emulsion, Lipofundin S, when given as part of a complete nutritive mixture from the three-liter bag total parenteral nutrition (TPN) delivery system. In vitro stability studies with mixtures corresponding to high and low nutritional intakes showed the fat emulsion to be stable during refrigerated storage for at least 6 days. The clinical use of Lipofundin S in 3-liter TPN bags was studied in 39 consecutive patients requiring TPN, and there were no untoward side-effects.

Do fibre containing enteral diets have advantages over existing low residue diets?

This study investigated the influence of fibre on the pattern of absorption of protein and carbohydrate following administration of polymeric enteral diet and also the effect of added fibre on frequency of bowel action, stool weight and gastrointestinal side effects during enteral nutrition. No difference was seen in frequency of bowel action, stool weight or gastrointestinal side effects in five patients fed with either a fibre free polymeric diet or with the same diet augmented with 24 g fibre/24 h. Addition of fibre did not significantly alter breath hydrogen excretion.

Relation between osmolality of diet and gastrointestinal side effects in enteral nutrition.

One hundred and eighteen patients with normal gastrointestinal function were randomly allocated to one of three feeding regimens in a double blind study to determine the relation between the tonicity of the diet and gastrointestinal side effects related to the diet and to evaluate the efficacy of "starter" regimens in reducing gastrointestinal side effects during enteral nutrition. Patients received a hypertonic diet with an osmolality of 430 mmol (mosmol)/kg (group 1), the same diet but with the osmolality increasing from 145 to 430 mmol/kg over the first four days (group 2), or an isotonic diet (300 mmol/kg) (group 3). All diets were prepared aseptically and administered by 24 hour nasogastric infusion.

Effect of catheter tunnelling and a nutrition nurse on catheter sepsis during parenteral nutrition. A controlled trial.

In a three-year controlled trial of subcutaneous catheter tunnelling as a method of reducing total parenteral nutrition (TPN) catheter sepsis 99 silicone catheters (52 tunnelled, 47 untunnelled) were inserted into the subclavian (94%) or jugular (6%) veins under aseptic conditions. The influence of a nutrition nurse, who joined the nutrition team after 18 months, on catheter sepsis rate was also documented. Catheter sepsis was confirmed in 13 of 47 (28%) untunnelled catheters and only 6 of 52 (11.

A controlled trial of aseptic enteral diet preparation--significant effects on bacterial contamination and nitrogen balance.

This study was performed to evaluate the clinical effectiveness of the 'standard' and aseptic enteral diet preparation techniques and to investigate the relationship between bacterial contamination of diets and symptoms during enteral nutrition. In this controlled study patients were prescribed isonitrogenous polymeric diets prepared using either 'standard' or aseptic techniques, administered by 24 nasogastric infusion. 'Standard' diet preparation resulted in significant bacterial contamination (p<0.

Limitations and drawbacks of 'fine bore' nasogastric feeding tubes.

The clinical use of unweighted nasogastric feeding tubes (n = 491) was compared with that of weighted nasogastric feeding tubes. No advantage was found in the use of the weighted tubes.

Enteral nutrition in malnourished patients with hepatic cirrhosis and acute encephalopathy.

Ten patients with histologically proven cirrhosis, admitted in grade I to II acute hepatic coma, received in addition to a standard dietary protein free "anticoma" regime, a continuous nasogastric infusion of a branched-chain amino acid enriched chemically defined enteral diet (Hepaticaid) containing an equivalent of 70 g protein/day for a mean of 7.3 days (range 3-23). No complications of therapy were observed and, specifically, the use of fine bore tubes did not provoke variceal hemorrhage.

Clinical indications for weighted enteral feeding tubes.

Simple unweighted fine bore feeding tubes have been used by our Nutritional Support Team for routine nasogastric feeding with success in large numbers of patients. Three clinical situations where mercury or tungsten weighted tubes offer advantages over fine bore tubes have been defined. Significant advantages in patients with concurrent endotracheal intubation, gastric atony and severe oesophageal stricturing are described.