Standard meals

M. E. O Neill and D. I. Thumham, Intestinal absorption of beta-carotene, lycopene and lutein in men and women following a standard meal Response curves in the triacylglycerol-rich lipoprotein fraction, Br. J. Nutr. 79 (1998) 149-159. 

The average person should consume 15 calories per pound of body weight each day. For example, a 130-pound person should consume 1,950 calories each day (15 calories/pound x 130 lbs = 1,950 calories). Approximately 30% of those calories should come from fat (1,950 calories x 0.30 = 585 calories/day). To illustrate the huge number of calories contained in the energy-dense fast food that is conveniently available, let s consider a standard meal from a popular fast-food chain3 ... 

Experimental. A second study was conducted with nine postmenopausal women age 51-65 yr. The subjects were fed standardized meals for 19 weeks. The mean composition for the 7-day menus of natural foods as % of total calories was 15% protein, 50% carbohydrate, 35% fat with a P/S ratio of 0.7, 10 g/day crude fiber, and less than 300 mg/day cholesterol. In addition, the diets supplied 1289 mg calcium, 1832 mg phosphorus, 2561 mg sodium and 5099 mg potassium daily. The diets met the RDA for all other nutrients. Calorie levels were adjusted to maintain body weight. The experimental meals were fed during the last six weeks of this 19-week period. No more than one liquid meal was consumed by each subject in one week. Fasting and postprandial samples of blood and urine were collected as in the previous study. Diuresis was induced by scheduled consumption of water. 

Drug/Food interactions Food enhances the bioavailability of metoprolol and propranolol this effect is not noted with nadolol, bisoprolol, or pindolol. The rate of carteolol and penbutolol absorption is slowed by the presence of food however, extent of absorption is not appreciably affected. Sotalol absorption is reduced approximately 20% by a standard meal. 

Following an overnight fast of at least 10 hours, subjects should receive either Treatments 1 or 2 above with 240 inL water. Food should not be allowed until 4 hours after dosing. Water may be allowed after the first hour. Subjects should be served standardized meals beginning at 4 hours during the study. 

Prior to and during each study phase, water may be allowed ad libitum except for 1 hour before and after drug administration. The subject should be served standardized meals and beverages at specified times. No alcohol or xanthine- or caffeine-containing foods and beverages should be consumed for 48 hours prior to each study period and until after the last blood sample is collected. 

Before and during each study phase, subjects should (1) be allowed water as desired except for lh before and after drug administration, (2) be provided standard meals no less than 4h after drug administration, and (3) abstain from alcohol for 24 h before each study period and until after the last sample from each period is collected. 

This study was conducted to investigate the pharmacokinetics of HMR1964 (insulin glulisine) and regular human insulin subcutaneously administered 2 min before a standard meal in pediatric type 1 diabetic patients from bom age classes (10 children and 10 adolescent subjects) in order to verify me sameness of differences seen in adults. 

Following an overnight fast, a dose is administered to the subjects with a controlled amount of fluid (250 ml of water). At a prescribed time, following the dose, a standardized meal is provided to each volunteer, again to standardize conditions so that results from any of the volunteers would not affect adversely. 

Total volume of pancreatic juice, amount or concentration of bicarbonate, and activities of pancreatic enzymes are measured in duodenal contents. The enzyme most commonly measured is trypsin, but amylase, lipase, chy-motrypsin, and elastase may also be evaluated. The Lundh test consists of administering a standardized meal consisting of 5% protein, 6% fat, 15% carbohydrate, and 74% nonnutrient fiber. Advantages of the Lundh meal are that it provides a physiological stimulus to the pancreas and is simple to administer. However, administration of the meal prevents determination of the total enzyme and bicarbonate or secretory volume. Moreover, it provides inadequate or no stimu-... 

Standardized meal Purified or synthetic porcine secretin Secretin as. above plus CGK analogue (CCK-8 or ceruletide)... 

The C-mixed chain triglyceride test is designed as a test of intraluminal pancreatic lipase activity.The substrate for the test is 1,3-distearyl>2( carboxyl- C) octanoyl glycerol, which contains long chain fatty acids in positions 1 and 3 and the C-labeled medium chain fatty acid (octanoic acid) in position 2 (Figure 48-9). The labeled substrate is administered orally to fasting patients with a standard meal of toast and butter. Breath samples are collected over a 5-hour... 

Table II shows effects on dialyzable iron caused by various substitution into the standard meal. These data have been reported elsewhere (Hiller et al. 28, Schricker et al. 29).

Figure 5. Comparison of estimated absorption ratios for standard meals using different methodology. All meals are compared to the beef meal. Ratios for human in vivo trials are derived from data from Cook and Monsen (1). Ratios are plotted on a logarithmic scale.

Several other organic acids which modify iron absorption are also listed in Table V. EDTA has received much attention for it forms a highly stable iron chelate, and one would expect it to inhibit iron absorption. When sodium ferric EDTA (NaFeEDTA) was fed directly as a liquid, inhibition of iron absorption was observed both in rats (A) and in man (40, 48). Inhibition increased with Increasing chelate concentration. This effect was also observed when NaFeEDTA was added to a diet, but only when the molar ratio of disodium EDTA to iron was 2 1 or greater (33). The inhibition was observed when NaFeEDTA was added to a standard meal described as "a typical American dinner," or when it was added to a semisynthetic meal (a diet designed to yield low iron bioavailability) (33). 

Disodium CDTA dihydrate 1 1 Standard meal FeCl3... 

Ferric EDTA 5-50 mg Standard meal radiolabeled corn FeEDTA... 

Fasting and meals should be adequately controlled during the study days, as food intake can significantly affect the absorption of drugs. Standardized meals, snacks and drinks should be planned and provided to study subjects in accordance with the clinical trial protocol. 

Planning, preparation, evaluation and service of standardized meals for bio-studies. 

Rautureau M, Bisalli A, and Rambaud JC. Bile-Salts and Lipids in Aqueous Intraluminal Phase During the Digestion of A Standard Meal in Normal Man. Gastroent Clin Biol 1981 5 417-425. 

Early clinical studies frequently involve the use of a concurrent inactive control. This can be important because the study procedures can be somewhat invasive and associated with some adverse effects themselves - for example, frequent blood draws resulting in a lowering of hematocrit. Without a concurrent control arm (even in a study of healthy participants) study sponsors and investigators would not be able to rule out a drug effect when observing such occurrences, which are expected, easily explained, and non-drug related. In early studies that involve inpatient facilities for close monitoring, other controls may be instituted, for example, standardized meals and set times for study procedures. 

Lafontaine, D. Mailhot, C. Vermeulen, M. Bissonnette, B. Lambert, C. Influence of chewable sucralfate or a standard meal on the bioavailability of naproxen. Clin.Pharm., 1990, 9, 773-777 [pharmacokinetics LOQ 1 pg/mL diphenylacetic acid (IS)]... 

Metabolism studies are required in the laboratory animal species used to determine the toxicological NOEL, as well as each food-producing animal species. ADIs are based on total residues of drug plus all metabolites, whereas MRLs comprise a single, quantifiable marker residue, most commonly the parent compound but in some instances a single metabolite or a mixture of compounds. To establish the MRL for each tissue, food consumption estimates are made on the basis of an assumed standard meal (the so-called food basket), as discussed further in Section 2.5.2.2. 

The composition of the standard meal varies between regulatory authorities, so that MRLs and WhTs also differ, even when the ADIs are the same. The differences in MRLs adopted by national bodies are attributable mainly to the levels of risk each is prepared to accept, the conditions of use, and methods for establishing MRLs. These differences... 

Fig. 18. Effect of GH-RIH on the secretion of insulin and ucagon after a standard meal and the hyperglycemia caused by feeding. 0> saline , GH-RIH, 13.3 /ig/min.

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