Fluoxetine treatment of the obese diabetic.

Fluoxetine, an inhibitor of serotonin re-uptake, has been shown to cause weight loss in humans and animals. In order to determine the effects in diabetic subjects, 48 male and female, obese, type 2 non-insulin dependent diabetics being treated with insulin were randomized to receive fluoxetine 60 mg or placebo once daily in double blind fashion for 24 weeks. In all subjects, this treatment was preceded by four weeks and followed by six weeks of single blind placebo washout treatment. Subjects performed daily home glucose monitoring and were given instruction in a 1200 kcal American Diabetes Association diet. Fluoxetine treated subjects who completed the trial (n = 16) lost more weight than placebo treated subjects (n = 20) (9.3 +/- 2.4 vs. 1.9 +/- 2.9 kg +/- s.e.m, P less than 0.05). Subjects in the fluoxetine group also showed a greater percentage decrease in insulin dose than those in the placebo group (46.9 +/- 7.6% vs. 19.3 +/- 7.6%, P less than 0.01). During active treatment, the change in serum glucose levels did not differ between the two groups, while glycohemoglobin fell more in fluoxetine treated subjects than in placebo treated subjects at two of four follow-up visits. These results suggest that fluoxetine may be of benefit in the treatment of obese patients with type 2 non-insulin dependent diabetes mellitus.     

The effect of the 5-HT re-uptake inhibitor fluoxetine on food intake and body weight in healthy male subjects

Eleven healthy male subjects of normal body weight received either 60 mg of the 5-HT re-uptake inhibitor fluoxetine (FXT) or matching placebo daily for two weeks, with a minimum one month wash-out period between treatments. Subjects attended on days 1, 8 and 15 from 08.50 h to 15.15 h in each treatment period when food and fluid intake, body weight, pulse and blood pressure, pupil diameter and plasma levels of FXT and NorFXT were measured and visual analogue scales (VAS) for subjective ratings of hunger, satiety, thirst, mood, arousal, nausea and gastric discomfort were completed. The trial was of a double-blind randomised crossover design, each subject acting as his own control. FXT reduced food intake by 15.7 per cent on day 1; by 12.6 per cent on day 8 but not on day 15. Hunger ratings were lowered by FXT on days 8 and 15 but not on day 1. Subjects were less thirsty when taking FXT but there was no concomitant reduction in fluid intake. FXT produced some mydriasis and slowed heart rate. In two weeks treatment with FXT there was a statistically significant weight loss of 1.07 kg compared to a mean weight gain of 0.15 kg on placebo. The incidence of reported side effects was low, drowsiness and stomach discomfort were reported by some subjects on days 8 and 15.     

The role of energy expenditure in the differential weight loss in obese women on low-fat and low-carbohydrate diets

We have recently reported that obese women randomized to a low-carbohydrate diet lost more than twice as much weight as those following a low-fat diet over 6 months. The difference in weight loss was not explained by differences in energy intake because women on the two diets reported similar daily energy consumption. We hypothesized that chronic ingestion of a low-carbohydrate diet increases energy expenditure relative to a low-fat diet and that this accounts for the differential weight loss. To study this question, 50 healthy, moderately obese (body mass index, 33.2 +/- 0.28 kg/m(2)) women were randomized to 4 months of an ad libitum low-carbohydrate diet or an energy-restricted, low-fat diet. Resting energy expenditure (REE) was measured by indirect calorimetry at baseline, 2 months, and 4 months. Physical activity was estimated by pedometers. The thermic effect of food (TEF) in response to low-fat and low-carbohydrate breakfasts was assessed over 5 h in a subset of subjects. Forty women completed the trial. The low-carbohydrate group lost more weight (9.79 +/- 0.71 vs. 6.14 +/- 0.91 kg; P < 0.05) and more body fat (6.20 +/- 0.67 vs. 3.23 +/- 0.67 kg; P < 0.05) than the low-fat group. There were no differences in energy intake between the diet groups as reported on 3-d food records at the conclusion of the study (1422 +/- 73 vs. 1530 +/- 102 kcal; 5954 +/- 306 vs. 6406 +/- 427 kJ). Mean REE in the two groups was comparable at baseline, decreased with weight loss, and did not differ at 2 or 4 months. The low-fat meal caused a greater 5-h increase in TEF than did the low-carbohydrate meal (53 +/- 9 vs. 31 +/- 5 kcal; 222 +/- 38 vs. 130 +/- 21 kJ; P = 0.017). Estimates of physical activity were stable in the dieters during the study and did not differ between groups. These results confirm that short-term weight loss is greater in obese women on a low-carbohydrate diet than in those on a low-fat diet even when reported food intake is similar. The differential weight loss is not explained by differences in REE, TEF, or physical activity and likely reflects underreporting of food consumption by the low-fat dieters.     

A dietary fibre supplement and weight maintenance after weight reduction: a randomized, double-blind, placebo-controlled long-term trial

Ninety-seven mildly obese females (BMI = 27.4 kg/m2) were in a randomized, double-blind, placebo-controlled trial treated for 52 weeks. The treatment consisted of a hypocaloric diet providing 5000 kJ/day (1200 kcal) and a dietary fibre supplement of 7 g/day for 11 weeks, (part I), followed by a diet providing 6720 kJ/day (1600 kcal) and a dietary fibre supplement of 6 g/day for 16 weeks (part II). Finally placebo was withdrawn and all still adhering subjects were given a dietary fibre supplement of 6 g/day and an ad libitum diet for the rest of the period (part III). Initial body weights were comparable, 76.9 +/- 0.8 kg in the fibre group versus 77.7 +/- 1.3 kg in the placebo group. During part I the weight reduction in the fibre group of 4.9 kg was significantly higher compared to that of 3.3 kg in the placebo group (P = 0.05). Accumulated weight reduction during part II was still significantly higher in the fibre group, 3.8 kg, compared to 2.8 kg in the placebo group (P less than 0.05). Total weight loss in the fibre group after 52 weeks was 6.7 kg. Probability of adherence to the treatment regimen was significantly higher in the fibre group from week 13 and onwards (P less than 0.01). Initial blood pressures were comparable. A significant reduction of systolic blood pressure occurred in both groups. A significant reduction of diastolic blood pressure occurred in the fibre group only, from 85.4 +/- 1.2 mmHg to 81.7 +/- 1.1 mmHg (P less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)     

Use of fluoxetine, a selective serotonin-uptake inhibitor, in the treatment of obesity: a dose-response study (with a commentary by Michael Weintraub)

Pharmacologic measures which increase serotonergic activity in the brain decrease food consumption and lead to decreased weight in animals. Fluoxetine, an inhibitor of serotonin reuptake, decreases food intake in animals and is associated with weight loss in depressed and otherwise healthy obese patients. To determine the most effective daily fixed dose which causes weight loss in nondepressed obese patients, fluoxetine (10, 20, 40 or 60 mg) or placebo was administered once daily for 8 weeks to 655 patients consisting primarily of women (mean age 40 years, mean weight 95 kg). Diet and activity were not controlled. The placebo-treated patients lost 0.6 +/- 2.3 kg. With the 60-mg fluoxetine dose, patients lost an average of 4.0 +/- 3.9 kg (P less than 0.001), with intermediate responses at the lower doses. Weight loss was proportional to the initial body mass index (weight/height squared). There were no statistically significant differences between any fluoxetine treatment group and placebo for discontinuations from the study. There were statistically significant dose-dependent increases in reports of asthenia, somnolence and sweating. Thus, fluoxetine 60 mg daily appears to be potentially effective for use in weight reduction.     

Treatment of morbid obesity by intraparietogastric administration of botulinum toxin: a randomized, double-blind, controlled study

OBJECTIVE: The stomach is the main target organ for bariatric surgery, but no medical treatment has been developed to increase satiety and decrease food intake via gastric pathways. The aim of our study was to investigate whether or not the intraparietogastric administration of botulinum toxin A (BTX), able to modify the motility patterns of the stomach, could be useful for treatment of obesity. DESIGN: Double blind controlled study. SUBJECTS: Twenty-four morbidly obese patients (mean weight (s.e.m.) 116.1+/-4.89 kg, mean body mass index (BMI) 43.6+/-1.09 kg/m(2)) were blindly randomized to receive 200 IU BTX or placebo into the antrum and fundus of the stomach by intraparietal endoscopic administration. MEASUREMENTS: We evaluated weight loss, BMI changes, satiety score, the maximal gastric capacity for liquids and the gastric emptying time (octanoic acid breath test). RESULTS: The two groups were homogeneous for anthropometric characteristics. Eight weeks after treatment, BTX patients had significantly higher weight loss (11+/-1.09 vs 5.7+/-1.1 kg, P<0.001) and BMI reduction (4+/-0.36 vs 2+/-0.58 kg/m(2), P<0.001) and a higher satiety score on a visual analogic scale (7.63+/-0.38 vs 4.72+/-0.44, P<0.001) than controls. Furthermore, BTX patients showed a significantly greater reduction in maximal gastric capacity for liquids (266.6+/-48 vs 139+/-31, P<0.001) and a greater prolongation in gastric emptying time (+18.93+/-8 vs -2.2+/-6.9 min, P<0.05). No significant side effects or neurophysiologic changes were found. CONCLUSIONS: Topical intragastric BTX was effective in reducing food intake and body weight in morbidly obese patients.     

Effects of an ad libitum low-fat, high-carbohydrate diet on body weight, body composition, and fat distribution in older men and women: a randomized controlled trial

BACKGROUND: The efficacy of ad libitum low-fat diets in reducing body weight and fat in overweight and obese adults remains controversial. METHODS: We examined the effect of a 12-week low-fat, high-complex carbohydrate diet alone (HI-CHO) and in combination with aerobic exercise training (HI-CHO + EX) on body weight and composition in 34 individuals with impaired glucose tolerance (20 women and 14 men; mean +/- SEM age, 66 +/- 1 years). Participants were randomly assigned to a control diet (41% fat, 14% protein, 45% carbohydrates, and 7 g of fiber per 1000 kcal), a HI-CHO diet (18% fat, 19% protein, 63% carbohydrates, and 26 g of fiber per 1000 kcal), or a HI-CHO diet plus endurance exercise 4 d/wk, 45 min/d, at 80% peak oxygen consumption (HI-CHO + EX). Participants were provided 150% of estimated energy needs and were instructed to consume food ad libitum. Total food intake, body composition, resting metabolic rate, and substrate oxidation were measured. RESULTS: There was no significant difference in total food intake among the 3 groups and no change in energy intake over time. The HI-CHO + EX and HI-CHO groups lost more body weight (-4.8 +/- 0.9 kg [P=.003] and -3.2 +/- 1.2 kg [P=.02]) and a higher percentage of body fat (-3.5% +/- 0.7% [P=.01] and -2.2% +/- 1.2% [P=.049]) than controls (-0.1 +/- 0.6 kg and 0.2% +/- 0.6%). In addition, thigh fat area decreased in the HI-CHO (P=.003) and HI-CHO + EX (P<.001) groups compared with controls. High carbohydrate intake and weight loss did not result in a decreased resting metabolic rate or reduced fat oxidation. CONCLUSION: A high-carbohydrate diet consumed ad libitum, with no attempt at energy restriction or change in energy intake, results in losses of body weight and body fat in older men and women.     

Dietary intake before and after gastric bypass and gastroplasty for morbid obesity in women

Fifty-one morbidly obese women were randomized to surgical treatment with gastric bypass (GBY) or gastroplasty (GPL). Their dietary intake was assessed preoperatively and 12 months postoperatively by two methods: diet history and 4-day weighted intake. Their protein intake was also checked against urinary nitrogen losses. There was a good correspondence between the results of the two dietary methods and also between estimated protein intake and urinary loss. This makes the results reliable. After 1 year the GBY patients demonstrated a mean weight loss of 41.6 +/- 10.8 kg (P less than 0.001 versus GPL) and a mean energy intake preoperatively of about 2400 kcal/day and postoperatively of 1050 kcal/day (P less than 0.05 versus GPL). The GPL patients lost 28.9 +/- 9.6 kg as a mean and had a preoperative intake of about 2500 kcal/day and a postoperative intake of about 1300 kcal/day. There were only minor changes in the quality of the food from the preoperative to the postoperative situation. Postoperatively the daily intake of several nutrients was below minimum values of recommended or required intake.     

Effect of a lipid-enriched diet on body composition and some regulatory hormones of food intake in growing rats

OBJECTIVE: The aim of the present study was to investigate the effects of a lipid-enriched diet on body composition and on main regulatory hormones of food intake (insulin, adiponectin, leptin, ghrelin). METHOD: Two groups of 16 rats, 35 days old, weighing 80+/-6 g, were constituted. One group (S) was given a standard diet during 10 weeks and served as control. The second group (L) was given a lipidic-enriched diet (containing: G: 41.5, L: 38.5, P: 20% calorie). Food and water were given "ad libitum". RESULTS: Total food intake, body weight, skeletal area and lean body mass of rats eating lipid-enriched diet were lowered (6694+/-178 vs. 8160+/-184 kcal, P=0.01; 431+/-38 vs. 468+/-25 g, P=0.003; 72.19+/-0.96 vs. 76.07+/-1.31 cm2, P=0.03; 369+/-18 vs. 409+/-23 g, P=0.0006), fat mass difference was not statistically significant (82.5+/-17 vs. 80+/-17 g, P=0.7). Blood ghrelin, adiponectin levels were lowered (1517+/-224 vs. 1915+/-579 pg/ml, P=0.03; 10+/-3 vs. 19+/-3 microg/ml, P=0.003) whereas insulin and leptin were unchanged (1.8+/-1.5 vs. 2.6+/-1.4 ng/ml, P=0.1; 16+/-11 vs. 13+/-10 ng/ml, P=0.4). CONCLUSION: A period of high fat diet in growing rats leads to a hypophagia, resulting in a lower lean body mass development. Some regulatory hormones of food intake did not change, while others significantly decreased, notably ghrelin being possible causal factor of the observed hypophagia linked to high fat diet.     

Does ephedrine promote weight loss in low-energy-adapted obese women?

A double-blind cross-over randomized study was performed in 10 selected adult overweight and obese (body mass index greater than 27) women who had been adapted to low-energy intake for a long period of time and who had shown difficulty in losing weight with conventional hypocaloric treatment. Combined with diet therapy (1000-1400 kcal/day), l(-)ephedrine hydrochloride (50 mg three times a day per os) or placebo were administered daily before each meal, after a period of stabilization with diet only for 1 month. Each pharmacological treatment lasted for 2 months. Weight loss was significantly (P less than 0.05) greater during the ephedrine period (2.41 +/- 0.61 kg) than during the placebo period (0.64 +/- 0.50 kg). None of the patients presented clinically important side-effects. These preliminary results seem to suggest a possible role for a thermogenic compound such as ephedrine in promoting weight loss in low-energy-adapted obese women.     

Short-term effects of sibutramine (Reductil) on appetite and eating behaviour and the long-term therapeutic outcome

OBJECTIVE: To evaluate the short-term effects of sibutramine on appetite and eating behaviour and whether these effects are related to the long-term therapeutic outcome. STUDY DESIGN: Short-term: randomised, double-blind, placebo-controlled, within-subject design. Long-term: prospective open clinical trial. SUBJECTS: A total of 36 obese (nine men/27 women) with a body mass index of 39.3+/-4.3 (mean+/-s.d.) (range 30.2 - 45.2) kg/m(2) and age 44.4+/-12.1 y. PROCEDURE AND METHODS:: First phase-short-term effects: At baseline, the subjects were treated for 14 days with 15 mg sibutramine/placebo (period 1) followed by a 2 weeks single-blind placebo washout period, the subjects received the alternative therapy for another 14 days (period 2). At baseline, and at day 14 in each treatment period the subjects arrived fasting to the laboratory for a standardised breakfast and an ad libitum standardised lunch using the VIKTOR set-up (a universal eating monitor) to evaluate the microstructure of the eating behaviour (ie amount of food consumed and eating rate). Visual Analogue Scales were applied before and after the meals as well as every hour between the meals to monitor the appetite. During this first phase, subjects were encouraged to keep their habitual eating habits. Second phase-long-term effects: All subjects received 10 months open treatment with 15 mg sibutramine and dietary advice in monthly group sessions with a dietitian. On the last day of this treatment period, the subjects returned to repeat the measurements of appetite and eating behaviour using the same test procedure as during the first phase of the study. RESULTS: First phase: Sibutramine influenced appetite and eating behaviour that could be registered after only 14 days of treatment. The amount of food consumed at lunch on VIKTOR was reduced by 16% by sibutramine compared to placebo, 335+/-123 g vs 399+/-126 g (P<0.0001). Second phase: Responders and nonresponders were defined as those who ate less vs more food on VIKTOR when treated with sibutramine compared to the baseline food intake in the first phase of the study. The weight reduction was greater for responders 11.8+/-6.2 (mean+/-s.d.) kg compared to nonresponders 6.8+/-2.7 (mean+/-s.d.) kg (P<0.05). CONCLUSION: Short-term effects of sibutramine on appetite and eating behaviour were identified such as a reduction in food intake and in ratings of subjective motivation to eat. Short-term sibutramine effects on eating behaviour are to some extent related to the long-term therapeutic outcome in obese subjects.     

Effect of three treatment schedules of recombinant methionyl human leptin on body weight in obese adults: a randomized, placebo-controlled trial

AIM: The aim of this study was to evaluate the effect on body weight and safety of subcutaneously administered recombinant leptin in obese adults and to evaluate whether the timing of recombinant leptin administration influences efficacy. METHODS: A randomized, double-blind, placebo-controlled, multicentre study was designed, comprising of a 3-week dietary lead-in followed by a 12-week leptin or placebo treatment period. A total of 284 overweight and obese (body mass index 27-37.0 kg/m(2)) predominantly white (98%) women (66%) and men (34%) with a mean (+/-s.d.) 46.8+/-10.4 years of age were randomized into three treatment groups with three matching placebo groups. Recombinant leptin was administered by subcutaneous injection [10 mg/morning, 10 mg/evening or 20 mg/day (10 mg twice daily)]. Patients were counselled at baseline to reduce dietary intake by 2,100 kJ/day (500 kcal/day), and dietary advice was reinforced every 2-4 weeks. RESULTS: No statistically significant change in body weight occurred with recombinant leptin treatment compared with placebo treatment in any treatment group. No clinically significant adverse effects were observed with the exception of an increase in injection-site reactions in patients treated with recombinant leptin (83%) vs. placebo (36%). CONCLUSIONS: Administration of recombinant leptin to an overweight and obese population, in addition to a mildly energy-restricted diet, was not efficacious in terms of weight loss at the doses and schedules studied. The hypothesis that nocturnal administration of recombinant leptin might have a specific effect on weight loss was not supported.     

The effect of sibutramine on energy expenditure and appetite during chronic treatment without dietary restriction

OBJECTIVE: To assess the contribution of a thermogenic effect to weight loss induced by eight weeks treatment with sibutramine (15mg/d) vs placebo in obese subjects. DESIGN: Randomised, placebo controlled, double blind study. SUBJECTS: Thirty-two (7 male, 25 female) healthy obese body mass index (BMI) 33.9+/-0.5 kg/m2 subjects completed the trial. MEASUREMENTS: Energy expenditure (EE) was measured by indirect calorimetry during a 32 h stay in a respiration chamber before and after 8 weeks treatment. Visual analogue scales were completed for assessment of appetite sensation. No dietary restriction was given. RESULTS: Sibutramine caused a significant weight loss compared with placebo (-2.4 kg vs+0.3 kg, P<0.001). Despite the larger weight loss after 8 weeks, 24-h EE did not decrease more in the sibutramine than in the placebo group (-2. 6% vs -2.5%, P=ns). When the changes in 24-h EE were adjusted for changes in body weight, 24-h EE decreased significantly less in the sibutramine group than in the placebo group (0.8% vs 3.8%, P<0.02). Sibutramine significantly decreased both hunger and anticipated food consumption, and increased satiety scores. CONCLUSIONS: The weight reducing effect of sibutramine in humans is caused by a dual mechanism: reduction of energy intake by increasing satiety and decreasing hunger and prevention of the decline in EE that follows weight loss.     

An evaluation of the atkins' diet

Low-carbohydrate (LC) weight-reducing diets are popular choices for self-dieters. Eighteen adults (BMI >/= 25 kg/m(2)) were enrolled in this short-term longitudinal study to evaluate dietary intake and weight on their "usual" diets and LC diet. Subjects were instructed to follow the first two phases of the diet described in Dr. Atkins' New Diet Revolution (2 weeks each). Total daily intake of calories and nutrients were calculated from 3-day food diaries. Body weight was measured at the end of each 2-week diet session. All enrolled subjects completed the study (age = 39.8 +/- 8.1 years, BMI = 36.6 +/- 6.6 kg/m(2)). Mean caloric intakes were 1400 +/- 472 kcal/day (Induction diet) and 1558 +/- 490 kcal/day (Ongoing Weight Loss diet) both p 相似文献   

Octreotide therapy of pediatric hypothalamic obesity: a double-blind,placebo-controlled trial

Hypothalamic obesity is a devastating complication in children surviving brain tumors and/or cranial irradiation. These subjects are thought to exhibit autonomic dysregulation of the beta-cell, with insulin hypersecretion in response to oral glucose tolerance testing (OGTT). We report the results of a randomized, double-blind, placebo-controlled trial of octreotide therapy for pediatric hypothalamic obesity. Eighteen subjects [weight, 100.6 +/- 5.6 kg; body mass index (BMI), 37.1 +/- 1.3 kg/m(2)] received octreotide (5-15 microg/kg x d s.c.) or placebo for 6 months. With octreotide, Delta weight (mean +/- SEM) was +1.6 +/- 0.6 vs. +9.1 +/- 1.7 kg for placebo (P < 0.001). Delta BMI was -0.2 +/- 0.2 vs. +2.2 +/- 0.5 kg/m(2), respectively (P < 0.001). OGTT documented Delta insulin response (peak - basal) of -417 +/- 304 pM after octreotide vs. +216 +/- 215 pM after placebo (P = 0.034). Improvement in physical activity by parent report was noted with octreotide, but not placebo (P = 0.03). For the octreotide group, changes in quality of life positively correlated with changes in insulin response (P = 0.041). Complications and adverse events were mild and self-limited. These data demonstrate the beneficial effects of octreotide in pediatric hypothalamic obesity. Octreotide suppressed insulin, and stabilized weight and BMI. Improved quality of life correlated with the degree of insulin suppression. Octreotide was safe and well tolerated.     

Effect of calcium supplementation on weight and fat loss in women

Data suggest that a diet deficient in calcium is associated with higher body weight and that augmenting calcium intake may reduce weight and fat gain or enhance loss. Our aim was to determine whether calcium supplementation during a weight loss intervention affects body fat or weight loss. Data were combined from three separate 25-wk randomized, double blind, placebo-controlled trials of 1000 mg/d calcium supplementation in 100 premenopausal and postmenopausal women. The primary outcome measures were change in body weight and fat mass adjusted for baseline values. There were no significant differences in body weight or fat mass change between the placebo and the calcium-supplemented groups in the pooled analysis (adjusted mean +/- SE; body weight, placebo -6.2 +/- 0.7 vs. Ca -7.0 +/- 0.7 kg; fat mass, placebo -4.5 +/- 0.6 vs. Ca -5.5 +/- 0.6 kg), and no significant interactions of calcium supplementation with menopausal/diet status. Analysis as separate trials also found no significant differences between the placebo and the calcium groups. Calcium supplementation did not significantly affect amount of weight or fat lost by women counseled to follow a moderately restricted diet for 25 wk. Nevertheless, the magnitude and direction of the differences for group means are consistent with a hypothesized small effect.     

Effects of agar (kanten) diet on obese patients with impaired glucose tolerance and type 2 diabetes

AIM: The aim of this study was to evaluate the efficacy of agar diet in combination with a conventional diet (traditional Japanese food) for obese patients with impaired glucose tolerance and type 2 diabetes. METHODS: After a 4-week run-in period on their habitual diets, 76 patients were randomly assigned to have conventional diet or conventional diet with agar. Both groups were on these diets for 12 weeks. Body weight, body mass index (BMI), glycaemic control, blood pressure, insulin resistance, total body fat, fat distribution and lipids were assessed before and after the experimental period. RESULTS: In both groups, after 12 weeks, mean body weight, BMI, fasting glucose levels, homeostasis model assessment-insulin resistance, and systolic and diastolic blood pressures had decreased significantly from their baseline values. HbA(1)c, visceral fat area, subcutaneous fat area, total body fat, insulin area under the curve after oral glucose tolerance test and total cholesterol decreased significantly in the agar-diet group. After 12 weeks, mean changes of body weight (-2.8 +/- 2.7 kg vs. -1.3 +/- 2.3 kg, p = 0.008), BMI values (-1.1 +/- 1.1 kg/m(2) vs. -0.5 +/- 0.9 kg/m(2), p = 0.009) and total cholesterol (-7.6 +/- 27.5 mg/dl vs. + 2.4 +/- 23.4 mg/dl, p = 0.036) were significantly greater in the agar-diet group than in the conventional diet group. CONCLUSIONS: The agar diet resulted in marked weight loss due to the maintenance of reduced calorie intake and to an improvement in metabolic parameters.     

Ileal transposition surgery attenuates the increased efficiency of weight gain on a high-fat diet

High-fat diets enhance weight gain in rats and humans. Ileal transposition surgery (IT) causes long-term weight loss on ad libitum food intake. This study was designed to study the effect of high-fat diets on weight loss following ileal transposition surgery. We weight matched 40 rats, performed IT or sham IT, and fed defined high-carbohydrate (12 percent kcal as fat) or high-fat (45 percent kcal as fat) diets for 15 weeks postsurgery (N = 10/group, data are means +/- s.e.m.). Overall, IT rats ate less than sham IT rats, 9587 +/- 304 v. 10,615 +/- 356 kcal (39.6 +/- 1.2 v. 43.8 +/- 1.5 MJ) (P less than 0.01), and gained less weight (-14 +/- 7.8 v. 46 +/- 13.7 g) (P less than 0.01). Sham IT rats had similar food intakes on the two diets, but body weights were increased on the high-fat diet. However, the IT rats on the high-fat diet did not gain more weight or have higher efficiency of weight gain than did the IT rats on the high-carbohydrate diet. We conclude that ileal transposition attenuates the increased efficiency of weight gain usually associated with consumption of a high-fat diet. The mechanisms of this decreased metabolic efficiency are unclear.     

Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents

OBJECTIVE: The present study was performed to investigate the efficacy and safety of a caffeine/ephedrine (CE) mixture in obese adolescents. SUBJECTS: Thirty-two (m/f = 16/16) obese children were included into the study. They were treated by diet (calculated daily energy requirement minus 500 kcal) and either CE or placebo (PL) for 20 weeks in a randomized double-blind placebo-controlled trial. Those weighing less than 80 kg took one tablet three times (100 mg/10 mg), whereas those weighing more than 80 kg took two tablets three times per day. There were three dropouts (girls) from the PL group. The age, weight body mass index (BMI) values (mean (range)) of the PL and CE groups were 16.0 (14.3-17.6) and 16.0 (14.2-17.7) y, 103.0 (77.2-126.4) and 104.8 (69.8-150.2) kg, 35.2 (28.3-42.3) and 36.5 (31.3-51.8) kg/m2, respectively. RESULTS: The decrease in relative body weight, BMI and body fat (measured by bioelectric impedance) was significantly (P < 0.05) greater in the CE group (mean +/- s.d.; 14.4 +/- 10.5%, 2.9 +/- 1.9 kg/m2, 6.6 +/- 6.0 kg) than in the PL group (2.2 +/- 5.8%, 0.5 +/- 1.6 kg/m2, 0.5 +/- 2.7 kg). Relative body weight decreased by more than 5% in 81% of the CE group, out only in 31% of the PL group. Adverse events were negligible and did not differ between the CE and PL groups. Withdrawal symptoms were mild, transient and their frequency and severity were not different between the placebo and active groups. CONCLUSION: According to the present pilot study, CE can be a safe and effective compound for the treatment of obesity in adolescents.     

Safety and efficacy of NT, an herbal supplement, in treating human obesity

OBJECTIVE: A human pilot study testing the safety and effectiveness of NT (Number Ten), a dietary herbal supplement made from rhubarb, ginger, astragulus, red sage and turmeric, to reduce food intake and cause weight loss. RESEARCH METHODS AND PROCEDURES: A total of 24 healthy women, 18-60 years, body mass index 25-35 kg/m(2) on no chronic medication were randomized to four groups of six: (1) oral freeze-dried NT 6 gm/day, (2) bed-dried NT 6 gm/day, (3) freeze-dried NT 12 gm/day or (4) placebo. Number Ten dose was escalated over 3 weeks and maintained for 8 weeks on a 700 kcal/day diet below maintenance. Food intake was measured at baseline and 4 weeks. Safety parameters were monitored weekly during dose escalation, week 6 and week 12. RESULTS: Weight loss was 1.8 kg for placebo and 0.4 kg for 500 mg NT whereas the 250 mg bed- and freeze-dried NT gained 0.43 and 0.87 kg, respectively (P=NS). The food intake increased 74 kcal with 250 mg freeze-dried NT and decreased 193.7 kcal with 500 mg freeze-dried NT (P<0.01). There was a dose-related incidence of loose stools in the NT groups, but no other toxicity was seen. Number Ten was found to contain sennosides, known laxatives and gallic acid, which is known to give weight loss in rodents. DISCUSSION: The human dose equivalent of NT used in this study was & frac16; and & frac112; of that shown to give well-tolerated weight loss in rodents. Number Ten will not be an effective dietary herbal supplement for the treatment of obesity owing to dose-limiting gastrointestinal toxicity.