Designing a quality assurance system for dietary data in a multicenter clinical trial: Women's Intervention Nutrition Study.

Reliable dietary intake data are essential for determining outcomes in nutrition-related clinical trials. Nevertheless, systems for quality assurance of dietary intake data are often slighted in the design of such trials and not incorporated or monitored as the trials continue. The Women's Intervention Nutrition Study (WINS), a multicenter clinical trial investigating the effect of reduction of dietary fat intake together with adjuvant systemic therapy on recurrence rates in and survival of postmenopausal women with early stage, surgically treated, breast cancer, has developed a quality assurance system to minimize errors and to produce data that are complete and reliable. The system involves development of standardized procedures for data collection, a quality control program to evaluate the data collected, and continual monitoring and reevaluation. The WINS system is offered as a model for studies collecting dietary intake data, no matter how simple or complex the trial design.

The influence of water on electrostatic charge retention and dissipation in pharmaceutical compacts for powder coating.

PURPOSE: The electrostatic properties of five materials commonly used in tabletting were investigated to assess their suitability for the novel technique of powder coating of pharmaceutical compacts. METHODS: Powder resistivity and compact voltage decay properties were determined under dry and wet conditions using purpose built equipment. RESULTS: The organic materials acted as insulators having resistivities > 10(13) omega m whilst dibasic calcium phosphate showed dielectric behaviour. A clear relationship between water content and resistivity was established for all materials. Electrical conduction across powder surfaces was demonstrated as the predominant mechanism by using low concentrations of magnesium stearate. In materials absorbing significant water a bulk mechanism was also present. After charge injection, decay rates were dependent on resistivity with those having the highest values exhibiting the slowest decay. The chemical nature of the materials was unimportant except at extremely high resistivities. Conditioning of the compacts with water reduced resistivities so that decay half-lives < 1 s were achieved. CONCLUSIONS: The electrical properties of the compact materials have been modified sufficiently to enable them to be considered suitable for powder coating.

Recent implications of weight loss in lung cancer management.

Successful lung cancer management has been hindered by the limited efficacy of dietary and pharmacologic interventions to prevent or reverse cancer-associated weight loss. The addition of total parenteral nutrition to chemotherapy in early trials was associated with survival detriment. Dietary counseling and enteral supplement use are common strategies that, when evaluated in randomized trials, do not improve anthropometrics or clinical outcome in lung cancer. Pharmacologic agents including corticosteroids, cyproheptadine, growth hormone, hydrazine sulfate, dronabinol, and pentoxyphylline also have failed to improve even anthropometric parameters in this condition. Megestrol acetate use is associated with appetite stimulation and non-fluid weight gain but, when evaluated in small cell lung cancer patients receiving defined chemotherapy, failed to improve global quality of life, and survival and was associated with toxicity. New strategies for nutrition-based interventions in lung cancer cachexia must consider their potential influence on tumor growth as well as on nutritional status. Recent lung cancer prognostic analyses have identified gender differences in outcome and weight loss that suggest potential targets for combined hormonal and nutrition interventions. Emerging information regarding the influence of specific fatty acids on tumor growth and cachexia development have identified additional approaches for future evaluation.

Enalapril attenuates the renal hemodynamic effect of acetazolamide in patients with diabetes mellitus: possible implications for tubuloglomerular feedback.

Acetazolamide (ACTZ), a carbonic anhydrase inhibitor, causes a fall in renal plasma flow and glomerular filtration (GFR). It is generally believed that the tubuloglomerular feedback (TGF) mechanism is responsible. This study examined whether, in patients with diabetes mellitus, the renal hemodynamic response to ACTZ is intact and whether the angiotensin-converting enzyme inhibitor, enalapril, which would be expected to block TGF, attenuates this response to ACTZ. Six men with insulin-dependent diabetes mellitus lived in a clinical research center for 8 weeks and received enalapril 5-15 mg/day from the third through sixth week. At 2, 6 and 8 weeks p-aminohippurate (PAH) and inulin clearances were performed over eleven 30-min periods. ACTZ (150 mg) was given intravenously after 180 min. In both the pre- and postenalapril studies, PAH clearance fell after ACTZ administration (-60 +/- 15 and -66 +/- 20 ml/min/l1.73 m2, respectively, p < 0.05 for each study). In contrast, with enalapril treatment PAH clearance after ACTZ tended to rise (29 +/- 12 ml/ min/1.73 m2, p = 0.07). GFR after ACTZ fell during the pre- and postenalapril studies (-19 +/- 3 and -13 +/- 1 ml/min/1.73 m2, respectively, p < 0.05 for each study) but not with enalapril treatment (-6 +/- 3 ml/min/1.73 m2). After ACTZ was administered, estimated renal vascular resistance rose during both the pre- and postenalapril studies (p < 0.05 and p < 0.01, respectively) and fell with enalapril treatment (p < 0.05). These data indicate that enalapril alters the renal hemodynamic effects of ACTZ in patients with diabetes mellitus, possibly by inhibiting tubuloglomerular feedback.

Altered metabolism and mortality in patients with colon cancer receiving chemotherapy.

To identify the metabolic effects of 5-fluorouracil and hydrazine sulfate therapy, 22 patients with colon cancer were admitted prospectively to a Clinical Research Center for serial measurement of counter-regulatory hormones, fasting hepatic glucose production (HGP), intravenous glucose tolerance test, plasma leucine appearance (LA) and leucine oxidation. Combined therapy was associated with a significant reduction in fasting glucose level (98 +/- 2 mg/dL to 94 +/- 2, P < 0.025) without a significant fall in fasting HGP (2.09 +/- 0.11 mg/kg/min versus 2.03 +/- 0.13; P > 0.05). The decreased fasting glucose value was associated with a mild but not statistically improved glucose disposal rate in response to the intravenous glucose tolerance test (1.34 +/- 0.07 %/min vs 1.47 +/- 0.11, P = 0.15). Plasma leucine appearance was significantly reduced after 2 months of therapy (63.3 +/- 3.0 mumol/kg/hr vs 57.1 +/- 3.9 mumol/kg/hr; P < 0.025), but leucine oxidation (11.5 +/- 1.1 mumol/kg/hr vs 11.2 +/- 1.1 mumol/kg/hr) was not altered. Despite the fact that plasma triiodothyronine concentrations significantly increased with therapy, it was not associated with plasma LA. Half of the patients with cancer died 14 +/- 4 months after the study, and the other half were alive 58 +/- 2 months later. Survival time can be estimated with 59% accuracy using plasma LA, HGP, carcino-embryonic antigen, and insulin concentration. Multiple regression analysis identified that plasma LA was related directly to length of survival time, and baseline HGP, carcino-embryonic antigen, and insulin concentration were related inversely to length of survival.(ABSTRACT TRUNCATED AT 250 WORDS)

Interaction between bile salts and beta-adrenoceptor antagonists.

The interactions between beta-adrenoceptor antagonists and bile salts were investigated by microcalorimetry. Nadolol and oxprenolol interactions with dihydroxy salts could be described by a 1:1 interaction model with the thermodynamic parameters indicating that the drugs were incorporated within the bile salt aggregates. This weak interaction was primarily hydrophobic although electrostatic attraction also played a role. Atenolol and metoprolol did not interact with the dihydroxy salts. None of the compounds interacted with trihydroxy bile salts or with salts below their aggregation concentration. Phase separation resulted when propranolol and alprenolol were present in dihydroxy salt solutions above a certain concentration with the interaction being of a hydrophobic and electrostatic nature. The implications of these results on in-vivo drug absorption are discussed.

Dietary intake and counseling, weight maintenance, and the course of HIV infection.

OBJECTIVE: To define relationships among dietary intake and counseling, weight maintenance, and the clinical course of patients infected with the human immunodeficiency virus (HIV). DESIGN: A prospective cohort study in an HIV clinic in a county hospital. SUBJECTS: HIV-infected patients (68 with and 40 without acquired immunodeficiency syndrome [AIDS]) who had a good performance status and no chronic diarrhea were assessed at entry to the study and after 6 months. The following assessments were made: energy and nutrient intake based on 7-day food records, anthropometric measurements, immunologic function as lymphocyte T-cell subpopulations (ratio of CD4 to CD8), and serum cholesterol level. Patients were monitored to determine clinical outcome. INTERVENTION: All patients received standardized dietary counseling designed to address identified intake deficiencies and maintain body weight. MAIN OUTCOME MEASURES: Changes in energy and nutrient intake, body weight, and clinical outcome (ie, time to AIDS-defining illness and overall survival time). STATISTICAL ANALYSES PERFORMED: Group differences (HIV group vs AIDS group) were sought using chi 2 analyses and Student's t test. A multivariate regression model was used to determined the best predictors of clinical outcome. RESULTS: At baseline, total energy intake (based on 30 kcal/kg usual body weight) was adequate in both HIV and AIDS patients (101 +/- 4% and 103 +/- 5% [mean +/- standard deviation] of need, respectively). Despite dietary counseling and continued maintenance of energy intake, body weight, serum cholesterol level, and CD4 level progressively decreased. Consequently, saturated fat intake was found to be inversely related (P < .01) to serum cholesterol level. Clinical outcome (after 3.5 years) was associated with baseline ratio of CD4 to CD8 (P < .001), weight (P < .01), and serum cholesterol level (P < .001). Multivariate analysis related ratio of CD4 to CD8 (P < .001) and weight maintenance (P < .001) to favorable outcome in the final model. APPLICATIONS: Weight loss in patients with HIV infection is independently prognostic of clinical outcome, and development of hypocholesterolemia is not favorable for clinical outcome. Because weight loss progresses despite conventional dietary counseling to identify energy need, interventions earlier in the disease course should be considered along with increased target levels for energy intake.

Very-low-energy diets alter the counterregulatory response to falling plasma glucose concentrations.

A consequence of short-term very-low-energy diets (VLEDs) in lean subjects is reactive hypoglycemia. We therefore tested the responses of overweight women on prolonged (14 d) VLEDs. Subjects lost 4.8 +/- 0.2 kg (mean +/- SEM, n = 13, P < 0.001). Group A (n = 6) was challenged with an oral-glucose-tolerance test (OGTT) and group B (n = 7) with an oral-sucrose-tolerance test (OSTT) on days 1 and 14. In group A, mean nadir plasma glucose after the OGTT was lower on day 14, 3.75 +/- 0.16 vs 4.7 +/- 0.19 mmol/L (P < 0.01), because of an accelerated rate of glucose decline (RGD, 26.7 +/- 3.3 vs 17.2 +/- 3.9 mumol.l-1.min-1, P < 0.05) late in the OGTT. Plasma insulin was also lower (P < 0.03) and the VLED suppressed two growth hormone (GH) peaks on day 14 (P < 0.05 for each). In group B on day 14, a greater RGD was also observed late in the OSTT, 16.9 +/- 4.1 vs 6.5 +/- 2.0 mumol.L.min-1 (P < 0.03). GH peaks were also significantly suppressed. We conclude that a VLED results in altered glucose regulation late after carbohydrate loading, characterized by an accelerated decline in plasma glucose and GH suppression. Patients on a VLED may be at risk for abnormally low plasma glucose concentrations when ingesting high carbohydrate loads.

The scope of nutrition intervention trials with cancer-related endpoints.

The National Cancer Institute currently is supporting three full-scale dietary modification trials with cancer-related endpoints. These studies are the dietary component of the Women's Health Initiative, designed to determine whether a low-fat diet will reduce the incidence of breast and colorectal cancer and/or coronary heart disease; the Women's Intervention Nutrition Study, designed to test whether a dietary fat reduction program will decrease breast cancer recurrence and increase patient survival; and the Polyp Prevention Trial, designed to determine whether a low-fat, high-fiber diet will reduce the recurrence of adenomatous polyps. Design issues associated with these full-scale dietary modification outcome trials have been addressed successfully in a series of feasibility studies. The ability to achieve a sustained reduction of 50% in dietary fat intake with maintenance of nutritional adequacy has been demonstrated in randomized trials of postmenopausal populations with resected breast cancer and in populations at increased risk for breast cancer. In these studies comparing dietary fat reduction programs with control lifestyles, a series of associated biologic changes, consistent with the self-reported dietary alterations, have been observed. These changes include body weight reduction, serum and/or plasma estradiol concentration reduction, fasting plasma cholesterol concentration reduction, and alteration in free fatty acid levels. Such results provide a substantial basis for reliably estimating the level of adherence that can be anticipated in trials of dietary change, a prerequisite for appropriate calculation of the sample size needed for multicenter, full-scale outcome studies. As a result, the efficacy of a series of dietary alterations (including fat reduction, fiber addition, and/or increased fruit and vegetable intake) on cancer-related endpoints with potential major public health significance (breast cancer recurrence, breast cancer development, and colonic polyp recurrence) now are being addressed definitively in prospective clinical trials.

Long-term effects of early nutritional support with new enterotropic peptide-based formula vs. standard enteral formula in HIV-infected patients: randomized prospective trial.

Despite association with adverse clinical outcome, human immunodeficiency virus (HIV)-associated malnutrition has been relatively refractory to conventional nutrition management. Consequently, a prospective randomized trial was conducted to evaluate a new peptide-based enteral formula (NEF) in contrast to a standard enteral formula (SEF) in patients with HIV infection. Eighty early-stage largely asymptomatic patients were randomized into a dietary regimen supplemented with either a ready-to-feed NEF (18.7% protein, 65.5% carbohydrate, 15.8% fat; 1.28 kcal/ml) or SEF (14% protein, 55% carbohydrate, 31% fat; 1.06 kcal/ml). Patients received 2-3 8-oz cans of the NEF or SEF supplement per day for 6 mo. Parameters evaluated at 0 (baseline), 3, and 6 mo included adherence, weight change, anthropometric measurements, serum biochemical indices, gastrointestinal symptoms, physical performance, and intercurrent health events (including hospitalizations). For the 56 evaluable patients, those supplemented with NEF maintained their body weight significantly (p = 0.04) better, had significantly (p = 0.03) more stable triceps skin-fold measurements, and had significantly (p = 0.04) lower blood urea nitrogen than patients consuming the SEF supplement. Consumption of the NEF supplement was also associated with significantly reduced hospitalizations during the 3- to 6-mo evaluation period (p = 0.02). The NEF supplement was well tolerated and did not result in untoward clinical effects. These data suggest that supplemental use of an NEF provides superior nutritional management compared with an SEF for patients with early-stage HIV infection.

Adjuvant dietary fat intake reduction in postmenopausal breast cancer patient management. The Women's Intervention Nutrition Study (WINS).

Management of localized breast cancer now commonly involves a breast-sparing approach combined with systemic adjuvant therapy resulting in improved cosmetic results and patient survival. Reducing dietary fat intake represents a conceptually new approach to further improve outcome of patients with resected breast cancer. The rationale supporting evaluation of dietary fat reduction in the management of patients with localized breast cancer is based on: (1) epidemiologic observations (along with biochemical and hormonal correlates) of major differences in stage-by-stage survival of patients with localized breast cancer comparing outcome in countries with low fat (Japan) versus high fat (U.S.A.) dietary intakes; (2) relationships between dietary fat intake and factors prognostic of clinical outcome in patients with established breast cancer; (3) effects of weight gain (especially that associated with adjuvant chemotherapy) on breast cancer clinical outcome; (4) in vivo animal studies demonstrating adverse influence of increased dietary fat intake (especially linoleic acid) on growth and metastatic spread of mammary cancer; (5) direct adverse effects of increased linoleic acid on human breast cancer growth in vitro; (6) plausible mechanisms which could mediate the effects of dietary fat intake reduction on breast cancer growth and metastatic spread; (7) demonstration of adherence to dietary fat reduction regimens in ongoing clinical feasibility studies including those involving postmenopausal patients with resected breast cancer; and (8) favorable sample size requirements for definitive assessment of dietary fat intake reduction influence on breast cancer growth and metastases (using as endpoints relapse-free survival and overall survival) in postmenopausal breast cancer patients with localized disease.

The taurine content of common foodstuffs.

There is growing evidence that taurine is a biologically valuable nutrient. However, there are few published data concerning the taurine content of different foods. We measured the taurine content of 29 meats, including both cooked and uncooked samples, nine dairy products, 17 infant or adult-feeding solutions and 48 plant foods (including vegetables, nuts or seeds, fruits and legumes. Taurine was detected in meats, dairy products, and infant feeding solutions but not in plant products or adult feeding solutions. Using these data, we compared calculated and measured daily taurine intakes in six defined diets. We present sample daily diets for omnivores, lacto-ovovegetarians and vegans (strict vegetarians), together with calculated taurine intakes.

Enalapril reduces albumin excretion in diabetic patients with low levels of microalbuminuria.

Although angiotensin-converting enzyme (ACE) inhibitors may lower urinary protein excretion, it is not known whether these agents can completely eliminate microalbuminuria. This study examined whether the ACE inhibitor, enalapril, can abolish low levels of microalbuminuria in diabetic patients. Six men with adult-onset, insulin-dependent diabetes mellitus, most of whom had low levels of microalbuminuria, were studied in a clinical research center, where they ate a controlled diet and performed regulated exercises daily. After 2 weeks of baseline measurements, the patients received 5-15 mg/day of enalapril for 4 weeks. They were then monitored for 2 more weeks without enalapril. Urinary albumin excretion (UAE) fell in each patient with enalapril treatment and was within the normal range at some time during enalapril treatment in 5 of 6 patients. After stopping enalapril, UAE rose. UAE was 53.6 +/- 20.7 (SEM), 31.5 +/- 8.9 and 39.4 +/- 8.0 mg/24 h during the baseline, enalapril and postenalapril periods, respectively (baseline vs. enalapril, p less than 0.02; postenalapril vs. enalapril, p less than 0.01). The magnitude of fall in UAE correlated with the baseline UAE (r = 0.90). During enalapril treatment, renal plasma flow and GFR did not change, although blood pressure fell slightly. These data suggest that enalapril can reduce or abolish UAE in diabetic patients with microalbuminuria. Whether long-term treatment with enalapril will continue to suppress microalbuminuria and prevent progressive diabetic nephropathy remains to be determined.

Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer.

This randomized, prospective, placebo-controlled clinical trial compares the influence on nutritional status and survival of hydrazine sulfate with placebo addition to cisplatin-containing combination chemotherapy in patients with unresectable non-small-cell lung cancer (NSCLC). The trial consisted of 65 patients with advanced, unresectable NSCLC who had had no prior chemotherapy, were at least partially ambulatory (Eastern Cooperative Oncology Group [ECOG] performance status [PS] level 0-2), and who had adequate hematologic, renal, and hepatic function. All patients received the same defined combination chemotherapy (cisplatin, vinblastine, and bleomycin) and the same defined dietary counseling with the addition of either three times daily oral hydrazine sulfate (60 mg) or placebo capsules. Hydrazine sulfate compared with placebo addition to chemotherapy resulted in significantly greater caloric intake and albumin maintenance (P less than .05). Considering all patients, survival was greater for the hydrazine sulfate compared with placebo group (median survival, 292 v 187 days), but the difference did not achieve statistical significance. In favorable PS patients (PS 0-1), survival was significantly prolonged (median survival, 328 days v 209 days; P less than .05) for hydrazine sulfate compared with placebo addition. In a multifactor analysis, PS, weight loss, and liver involvement were the final variables. Objective response frequency and toxicity were comparable on both arms. Hydrazine sulfate may favorably influence nutritional status and clinical outcome of patients with NSCLC. Further definitive studies of hydrazine sulfate addition to therapeutic regimens in NSCLC are warranted.

Nutritional status, gastrointestinal dysfunction, and survival in patients with AIDS.

The clinical course of 71 patients with acquired immune deficiency syndrome (AIDS) was evaluated to determine relationships among nutritional status, gastrointestinal symptoms and survival. At baseline, weight loss was present in 98%, hypoalbuminemia (less than 3.5 g/dl) was present in 83%, and gastrointestinal symptoms included pharyngitis (54%), diarrhea (42%), nausea (23%), dysphagia (21%), and anorexia (18%). Both the magnitude of body weight loss and the serum albumin level were strongly associated with life-table analysis of survival. For weight loss, median survival of 520 vs. 48 days occurred in patients with less than 10% versus greater than 20% baseline weight loss, respectively (p less than 0.01). The substantial influence of serum albumin on survival is outlined below. (table; see text) In almost all cases, serial evaluation demonstrated progressive linear decrease in body weight and albumin. In patients with normal baseline albumin, the rate of 0.7 mg/dl albumin decrease per day was less than half that in patients with baseline hypoalbuminemia. A projected "time to develop an albumin level less than 2.5 g/dl" was calculated for patient groups based on initial albumin level and the rate of albumin decrease. The calculated interval was similar to the actual median survival time observed in these groups. We conclude that 1) nutritional status may represent a major determinant of survival in AIDS and 2) the rate of albumin decrease may define a function limiting survival of individual patients with AIDS.

Effect of altering the proportion of dietary fat and carbohydrate on exercise gas exchange in normal subjects.

A low proportion of dietary calories as carbohydrate has been suggested for patients with chronic obstructive pulmonary disease, because oxidation of carbohydrate (CHO) compared to fat results in greater CO2 production (VCO2) and, at the same arterial PCO2 (PaCO2), higher alveolar and minute ventilation (VE) and increased dyspnea. We hypothesized that a low CHO-high fat diet, although reducing VCO2 and VE at rest, might result in only a small change in VCO2 and VE during exercise. Eight healthy volunteers were randomized to receive for 24 h either isocaloric diets containing 10% or 70% of total calories from CHO (remainder of nonprotein calories from fat). Measurements of VCO2, VE, and respiratory gas exchange ratio (R) were made at rest and during constant work rate cycle exercise below the anaerobic threshold. Five to seven days later, the alternate diet was given and the studies were repeated. At rest, mean VCO2 and R were significantly lower after the low CHO diet compared to the high CHO diet. Mean resting VE was less but not significantly (high CHO 9.6 [0.7] versus low CHO 8.7 [0.8] L/min, mean [SEM]). During exercise, mean VCO2 and R were significantly less after the low CHO diet, but mean VE was only slightly smaller and not significantly different between diets (high CHO 25.4 [1.1] versus low CHO 24.0 [1.0] L/min). The increase in VCO2 from rest to exercise was relatively independent of the substrate mix recently consumed, suggesting that the exercising muscles use stored muscle glycogen as substrate during short bouts of low-intensity exercise despite changes in substrate utilization by nonmuscle tissues at rest.(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of energy intake on nutritional status in maintenance hemodialysis patients.

Although maintenance hemodialysis (MHD) patients are often wasted, little is known about their dietary energy needs. We studied four men and two women in a clinical research center while they received diets providing 45, 35 and 25 kcal/kg desirable body weight/day; diets were fed, in random order, for 21 to 23 days each. Protein intake, 1.13 +/- 0.02 (SEM) g protein/kg/day, was similar with all three diets. Body weight rose with 45 and 35 kcal/kg/day (P less than 0.05) and fell with 25 kcal/kg/day (P less than 0.05). Nitrogen balance, adjusted for estimated unmeasured losses, was neutral with 45 and 35 kcal/kg/day and negative with 25 kcal/kg/day. Balance was neutral or positive in 6 of 6, 4 of 6, and 0 of 6 patients fed 45, 35, 25 kcal/kg/day, respectively. Nitrogen balance, many plasma amino acids and changes in body weight, mid-arm circumference, mid-arm muscle area and body fat each correlated with energy intake. Resting energy expenditure was normal. The energy intake estimated from regression equations to maintain neutral nitrogen balance was 38.5 kcal/kg desirable weight/day; for body fat and weight, it was 32 kcal/kg/day. These data suggest that MHD patients have normal energy expenditure and approximately normal requirements for maintenance of protein balance, body weight and body fat. An average energy intake of about 38 kcal/kg desirable weight/day may be necessary to maintain nitrogen balance in these patients.

Symptoms potentially influencing weight loss in a cancer population. Correlations with primary site, nutritional status, and chemotherapy administration.

A nutritional assessment including determination of symptoms potentially influencing weight loss was prospectively performed on 254 consecutive cancer patients with favorable performance scores (Eastern Cooperative Oncology Group [ECOG] level 0 to 2). Primary cancer sites included the following: non-small cell lung (n = 93), colon (n = 50), prostate (n = 23), oropharyngeal (n = 18), breast (n = 15), gastrointestinal (n = 13), and other (n = 42). Thirty-nine percent of patients had received no prior chemotherapy or radiation therapy. Common symptoms in the population were abdominal fullness (61%), taste change (46%), constipation (41%), mouth dryness (40%), nausea (39%), and vomiting (27%). Current caloric intake was surprisingly similar in 170 patients with weight loss (percent usual body weight [PUBW], less than or equal to 95%) compared with 84 without weight loss (PUBW, greater than 95%; 31.4 +/- 1.5 versus 30.5 +/- 2.1 kcal/kg/d, respectively). Symptoms identified by multivariate analysis as occurring significantly more frequently in populations with weight loss included abdominal fullness (P less than 0.001), taste change (P less than 0.002), vomiting (P less than 0.005), and mouth dryness (P less than 0.02). There was no difference in frequency of symptoms between patients with or without prior chemotherapy. These results indicate that gastrointestinal/oral symptoms potentially influencing weight loss are prevalent early in the course of cancer patients with unresectable disease, regardless of current nutritional status, caloric intake, or prior therapy experience.

Diet composition and lipoprotein lipase (EC 3.1.1.34) activity in human obesity.

1. Adipose tissue lipoprotein lipase (EC 3.1.1.34; AT-LPL), a rate-limiting enzyme in triglyceride storage in adipose tissue, is hormonally regulated and may be important in the maintenance of obesity. 2. In twelve obese women, AT-LPL activity was measured before weight loss, during weight loss and after 1 and 2 weeks of weight maintenance on either a high-carbohydrate or a high-protein diet. 3. When related to tissue weight, AT-LPL activity during the 2 weeks of weight maintenance was higher than the initial AT-LPL activity; there was no difference when activity was expressed per cell. 4. Changes in AT-LPL activity were not affected by diet composition. AT-LPL activity correlated with insulin levels and a change in insulin sensitivity of AT-LPL was observed after weight loss.