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The influence of food intake on the bioavailability of metoprolol from an OROS system has been investigated. No significant difference was found between OROS administration to fasting subjects or after breakfast in any of the kinetic parameters (AUC, Cmax, tmax, C24 and lag time). Therefore, metoprolol OROS can be administered with breakfast.
Recombinant DNA technology allows the production of insulin analogues with faster absorption rates from subcutaneous tissue as compared to soluble human insulin. The human insulin analogue B10Asp (mono/dimeric) is absorbed twice as fast as soluble human insulin (hexameric). A double blind, randomised crossover study with a 1-month run-in period and two 2-month treatment periods was performed in 21 male insulin-dependent diabetic (IDDM) patients aged 18-40 years in order to compare the metabolic control obtained with equimolar doses of the analogue B10Asp vs soluble human insulin (Actrapid) given as mealtime insulin and intermediate acting isophane insulin (Protaphane) at bedtime. At the end of each 2-month study period, the patients were admitted to the metabolic ward. We found significantly higher plasma insulin/analogue levels after breakfast, lunch and dinner with B10Asp as compared to Actrapid (p < 0.05). The plasma insulin/analogue levels were significantly lower before lunch and dinner with B10Asp as compared to Actrapid (p < 0.05). Also, the plasma insulin/analogue level tended to be lower at bedtime when comparing B10Asp to Actrapid. The 24-h blood glucose profiles showed identical fasting blood glucose, significantly lower blood glucose after breakfast with the analogue (p < 0.05), no differences in blood glucose after lunch and dinner but a significantly higher blood glucose at midnight using the analogue (p < 0.05). The overall 24-h mean blood glucose concentrations, the daily insulin dose, HbA1c, diet, home blood glucose monitoring and frequency of hypoglycaemia were almost identical in the two treatment periods.(ABSTRACT TRUNCATED AT 250 WORDS)
We have studied the systemic availability of oral albendazole in 6 patients with echinococcosis either fasting or with breakfast. Albendazole sulphoxide, the pharmacologically active principle, was assayed by HPLC. Mean plasma concentrations and AUCs were 4.5 times higher when albendazole was given with breakfast than when administered in the fasting state. We conclude that therapy of echinococcosis with albendazole requires the drug to be taken with meals and that administration on an empty stomach might be more appropriate when intraluminal effects are desired, e.g. for intestinal parasites.
The absorption of theophylline from a sustained release tablet preparation ( Theolin Retard 300 mg) was studied in 10 subjects both when fasting and immediately after a standardized breakfast. Intravenous aminophylline was used as the reference material. Food did not influence the absorption from Theolin Retard. The bioavailability was complete (93% after 30 h) both with and without food, and no difference was found in the time to peak of the plasma concentration curve (7 h), or the mean residence time (14 h). The absorption characteristics, with predominantly zero order kinetics, did not change with concomitant intake of breakfast.
Six maturity onset diabetic patients took glibenclamide 5 mg by mouth, every morning 10 min before a standard breakfast. Serum levels of immunoreactive glibenclamide, glucose and immunoreactive insulin were measured repeatedly on the first and 15th days of treatment. Measured glibenclamide blood levels were in close agreement with an analogue computer simulation of data obtained from healthy volunteers: there was no accumulation of drug in the blood, but there was strong evidence for the existence of a slowly equilibrating "deep" compartment. Considerable insulin release and correction of the breakfast-induced hyperglycaemia were observed immediately after administration of the drug, as well as 5 h later, at lunch time. The clinical significance of blood levels of glibenclamide, as well as the correlation of pharmacokinetics with pharmacodynamics, are discussed in the light of these results.
The effect of 4.75 g guar gum, a fibre preparation, on the absorption of 2.5 mg glipizide has been studied in 10 healthy volunteers given a standard breakfast. Three different experimental protocols were used: glipizide without guar gum (Treatment 1), glipizide with guar gum (Treatment 2) and guar gum 30 min after the drug together with breakfast (Treatment 3). The serum glipizide at 30 minutes was higher during Treatment 2 than Treatment 3 (p less than 0.01), but neither differed from the control treatment. The AUCs for glipizide were calculated up to 8 hours. They did not differ significantly between the treatment, although there was a non-significant trend to lower values during Treatment 3. Serum insulin and blood glucose levels were determined up to 3 h. Corresponding to differences in the glipizide concentration, serum insulin was highest and blood glucose lowest at 30 minutes during Treatment 2. According to this single dose study, guar gum does not have any substantial deleterious effect on the absorption of glipizide. The lack of effect may be due to the complete gastrointestinal absorption of glipizide.
The steady state absorption of erythromycin from enteric-coated pellets of erythromycin base was compared with that from enteric-coated tablets in a randomized, two-way cross-over study in 24 healthy adult volunteers. A higher mean individual peak concentration (p less than 0.01), and a greater mean area under the serum concentration-time (0-8 h) curve (AUC, p less than 0.01) was produced by the enteric-coated pellets, when the preparations were administered 1 hour before breakfast. No significant differences in the kinetic parameters between the two preparations were observed when they were taken during a non-standardized breakfast, as concomitant food intake was found to reduce both the peak levels and the AUC-values (p less than 0.01) produced by the pelleted preparation.
Six healthy men walked 37 km (23 miles) per day over a 3-lap course for each of 4 consecutive days. Subjects were allowed breakfast and an unrestricted diet was consumed after completion of the walk, but no food was consumed during or between laps. At a later date the same subjects walked over the same course after an overnight fast and without breakfast. Completion time for each lap was 139 +/- 1 min (mean +/- SE) and exercise intensity was equivalent to 17 +/- 1% VO2max. Mean 24h energy intake was 14.5 +/- 0.8 MJ during the fed walk. Estimated daily energy expenditure was 12.0 MJ. Blood glucose concentration fell significantly on the first, third and fourth days of the fed walk, but no subject became hypoglycaemic. Glucose concentration did not fall during the fasted walk and was significantly higher pre-exercise and at the end of laps one and three when compared to the first day of the fed walk. Blood alanine concentration fell significantly after the end of the first lap of each day of the fed walk but not during the fasted walk. Blood lactate levels did not change during the course of either walk. Plasma free fatty acid, glycerol and blood 3-hydroxybutyrate concentrations were unchanged during the passage of the first lap on each day of the fed walk, but all three had increased significantly by the end of the first lap of the fasted walk.(ABSTRACT TRUNCATED AT 250 WORDS)
The effects of a contingency management program utilizing a reinforcing event (breakfast) were investigated in respect to cabin-cleaning and self-report behaviors in a group of nine male campers, ranging in age from 11 to 13. Control of cabin-cleaning behavior was clearly demonstrated. The large discrepancy between camper self-ratings and counselor ratings disappeared when the opportunity to line up for breakfast was made contingent upon both accuracy of self-report and improved cleaning performance.
In 4 patients studied after cholecystectomy and common-duct exploration for cholesterol gallstones, bile salt (BS) and phospholipid (PL) output and bile flow increased significantly in response to breakfast, but cholesterol (Ch) output was unaltered. Simultaneously, Ch concentration decreased while PL and BS concentrations did not change. The degree of Ch saturation of bile, [BS PLUS PL]/[ch], decreased in each study, whether or not the original ratio indicated Ch supersaturation; in 3 of 5 studies, an initially super-saturated bile became unsaturated with Ch in response to breakfast. No significant changes were noted after lunch. During interruption of enterohepatic circulation (EHC), studies with radiolabeled bile acids indicated that the increased bile acid output in response to meals was secondary to increased recirculation of intestinal bile acids rather than to de novo bile acid synthesis. This mechanism may account for the adequate delivery of BS and for the decreased degree of Ch saturation of bile postprandially in cholecystectomized patients.
The digestibility of proteins and individual amino acids of nineteen selected foods was determined by an in vitro assay. Samples were hydrolysed with pepsin for 30 minutes in an acidic medium; the pH was then raised to 7.5 and the mixture poured into the dialysis bag (molecular weight cut-off 1000) of a digestion cell with pancreatin. Digestion products, mixtures of free amino acids and low molecular weight peptides which pass through the dialysis membrane, were collected for 6 hours by sodium phosphate buffer circulation. All proteins from animal sources displayed a digestibility similar to casein, except for breakfast sausage. Vegetable proteins showed intermediate digestibility, except for cereals (lower) or peanut butter (higher). Target amino acids of enzymes were generally more readily hydrolysed. However, compared to other animal proteins, glycine in milk products, valine, isoleucine, methionine and lysine in breakfast sausage and hot dog, and histidine in tuna were more easily released. Overheating of non-fat dried milk not only reduced the lysine digestibility, but also that of methionine, phenylalanine, histidine and cystine. Among vegetable proteins, wheat products were characterized by a relatively greater release of threonine, isoleucine and histidine, and peas by a lower digestibility of methionine and lysine. Proline of soy isolate and isoleucine of pinto bean were resistant to hydrolysis while arginine of pinto beans and of rice-wheat-gluten was easily released.
The neurotransmitter serotonin significantly contributes to the regulation of food intake and appetite behaviour. The cerebral serotonin synthesis depends on the availability of the precursor tryptophan. To examine how diets with different carbohydrate, protein and tryptophan content affect food preferences and the mood, healthy obese and non-obese male adults consumed the following isocaloric diets at breakfast: standard diet (60% carbohydrate), protein-rich diet (35% carbohydrate, 40% protein), carbohydrate-rich diet (80% carbohydrate), tryptophan supplemented diet (standard diet + 1.5 g tryptophan). The plasma concentration of tryptophan (TRP) and large neutral amino acids (LNAA) is determined by their uptake with the diet. In obese and non-obese adults the TRP/LNAA-quotient rose significantly by upto 0.40 to 0.57, following the tryptophan supplemented breakfast. The protein-rich diet reduced the TRP/LNAA-quotient. The preference of protein-rich food after the consumption of carbohydrate-rich diets (60-80% carbohydrate) was diagnosable with the non-obese person and not with the obese person. No obvious connection was detected between nutrient preferences and plasma TRP/LNAA-quotient. There was no influence of the plasma TRP/LNAA-quotient after meals with different nutrient relation on mood. Therefore it is concluded that different carbohydrate and protein content and also additional tryptophan supplementation of single meals is not able to modify the brain serotonin synthesis and release in healthy people in a kind that serotonin induced behaviour would be changed, at least on a short time basis.
Seven-day food records of the MONICA project Augsburg dietary survey, which were collected between October 1984 and May 1985 in 899 men aged 45-64 years (random sample), were used to analyze meal patterns. Among other variables, the emphasis was placed on meal frequency and rhythm, frequency of meal combinations, place and time of meal intake as well as on the contribution of different meals to selected nutrient intake. Breakfast delivers 17%, lunch 29%, and dinner 33% of the total daily energy intake; all other meals (snacks) deliver 21% of the energy intake. The mean contribution of the three major meals, such as breakfast, lunch and dinner to daily protein intake is 14%, 36%, and 36%; to fat intake 17%, 33%, and 35%, and to carbohydrate intake 23%, 25%, and 29%, respectively. Data on meal patterns are useful for the development of preventive strategies.
With regard to the reported knowledge concerning the health value of food in 9-10-year-old children (DGE, 1984) the question arose of whether this knowledge is also valid if pupils have to evaluate meals. Twenty-seven photos of meals (9 each of breakfast, lunch and supper) were presented to 252 children of the age groups 6-7, 9-10 and 12-13 years. By means of these photos, they were requested to organize their meals for 3 days. Subsequent to this procedure the children were asked to evaluate the meals with regard to their health value. The presented meals were classified by five experts of nutrition as more healthy, indifferent and less healthy. The results showed an improved selection of more healthy meals with increasing age. Likewise, the selection of meals for lunch and supper was better than the one for breakfast. There were no differences between boys and girls and children with and without experience of dieting. The evaluation of more healthy and less healthy meals demonstrated an improvement with increasing age. In contradiction to these results, children within all age groups showed a very low level of estimation (10%) for indifferently classified meals and this level did not improve with increasing age. The results were discussed concerning the establishment of an appropriate education of nutrition with regard to the developmental stage and the emotional and motivational engagement of the children.
For patients with phenylketonuria the daily ingested phenylalanine-free amino acid mixture is the most important source of nitrogen. It is recommended to ingest one third of the total amount combined with main meals. Some patients, especially the older ones, do not follow this recommendation; they ingest the entire daily amount of amino acid mixture in one portion. This intake mode leads to an increased oxidative utilization of the amino acids. To set up an example for this metabolic phenomenon, a 13C-leucine breath test was performed in one female phenylketonuric patient. She ingested a third of her daily amount of the amino acid mixture combined with an oral tracer of 3 mg 13C-leucine/kg body weight at breakfast. The breath test was carried out by a standardized time schedule over 5 h. Three days later the breath test was repeated when she ingested the total amount of amino acid mixture in only one portion at breakfast. Total daily caloric intake and food composition were not changed. On both days a 24 h urine was collected to determine total nitrogen loss. The 13C-content of expired air was analysed by gas isotope ratio mass spectrometry, the total nitrogen content was determined using a combustion unit. The 13C-elimination rate as a percentage of the applied 13C-tracer was 9.5% on the first test day as compared to 19.6% on the 2nd day. The corresponding total nitrogen excretion was increased (4.3-6.9 g/24 h).(ABSTRACT TRUNCATED AT 250 WORDS)
The pharmacokinetics of ciprofloxacin was studied in three groups of healthy volunteers comprising a total of 16 males and 16 females (age 21-35 years; body weight 52-80 kg). Single oral doses of 50, 100, 250, 500 and 750 mg were given to fasting subjects. The 250 mg dose was repeated after a breakfast. Intravenous doses of 50, 100 and 200 mg were given by short infusion in a randomized cross-over sequence. Concentrations of the drug in serum and urine were determined by high-performance liquid chromatography and by a microbiological assay. Mean peak concentrations between 0.37 +/- 0.49 mg/l (100 mg dose) and 1.97 +/- 0.50 (750 mg dose) were measured 60-75 min after oral administration. Twelve hours after 750 mg ciprofloxacin, serum concentrations were 0.15 +/- 0.05 mg/l. Taking a breakfast reduced absorption by 15-20% compared to the fasting state, as judged by peak concentrations, AUC and renal excretion. After 200 mg i.v. (20 min infusion period), initial serum concentrations of 4.0 +/- 1.2 mg/l were observed which declined 12 h later to 0.070 +/- 0.025 mg/l. Mean cumulated recovery of ciprofloxacin from urine over 24 h varied between 25.5% and 33.6% of oral doses and between 53.2% and 57.4% of intravenous doses. Two of the three metabolites seen in the chromatograms were identified as M1 and M3 (oxo-ciprofloxacin). Cumulated renal excretion after an oral 250 mg dose was 1.2 +/- 0.4% of M1 and 5.5 +/- 1.6% of M3.(ABSTRACT TRUNCATED AT 250 WORDS)
B-cell function was studied in 20 diabetic children, with an age at onset of diabetes between 1.16 years (8.8 +/- 4.0). Serum samples were taken before the first insulin injection and after 1, 3, 6, 9 and in a few patients after 18 months. At 3, 9, and 18 months the patients were also given a standardized breakfast load. Serum proinsulin, C-peptide, IRI and insulin antibodies (IgG) were determined. At onset 19 patients had measurable C-peptide (0.22 +/- 0.17 pmol/ml; range 0.05-0.58). Proinsulin varied between 0.000-0.25 pmol/ml (0.069 +/- 0.071) and at onset amounted to 31.3 +/- 29.4 (0.100)% of C-peptide as compared to 3.3 +/- 1.1 (1.7-6.6) in non-diabetics. A long partial remission was significantly correlated to a low proinsulin/C-peptide ratio at onset. In patients with low fasting proinsulin and no insulin antibodies, breakfast stimulation was accompanied by an increased proinsulin release at 3 and 9 months. The results suggest that abnormal proinsulin secretion is a feature of the 'B-cell exhaustion' complex in juvenile-onset diabetes.
Two new glucosidase inhibitors (BAY m 1099 and BAY o 1248) were studied in volunteers and type II diabetics under various conditions. In 6 non-diabetic controls BAY m 1099 when given 3 X 50 mg/day caused a marked depression of the post-meal glucose rise. The effect was found to be more marked after breakfast than after lunch or after dinner. In type II diabetics BAY m 1099, when given in a dose of 2 X 25 mg/day over one week, had no significant effect on post-meal glucose or serum insulin levels. BAY o 1248, when given as a single dose of 15 mg in the morning to type II diabetics, induced a significant decrease of post-meal glucose rise (35 mg/dl after breakfast, 25 mg/dl after lunch) when compared to placebo. Although in parallel serum insulin levels were slightly lower, this change was statistically not significant. The drug reduced glycosuria by 50%. Both compounds induced side effects, such as flatulence or diarrhea when given in therapeutically effective amounts, but were tolerable in most cases. On a weight basis BAY o 1248 was found to have greater therapeutic effects than BAY m 1099. Both drugs can be recommended for use in unsatisfactorily controlled type II diabetics. Further studies should concentrate on the critical dosage which may strike a satisfactory balance between effects and side effects.