Development and validation of a structured questionnaire for the diagnosis of oral allergy syndrome in subjects with seasonal allergic rhinitis during the UK birch pollen season.

BACKGROUND: Birch pollen-associated oral allergy syndrome, also known as pollen-food syndrome (PFS), is the most common food allergy in adults in the United Kingdom. Because of its characteristic rapid onset of oro-pharyngeal symptoms associated with specific plant foods, it was hypothesized that a history-based questionnaire could accurately diagnose PFS in subjects with rhino-conjunctivitis symptoms in the UK springtime. OBJECTIVE: In this study of diagnostic accuracy, we aimed to validate a simple PFS diagnostic questionnaire and algorithm against a reference diagnostic test method (RTM) comprising diagnosis by expert evaluation of clinical history, skin prick tests and oral food challenge, in subjects reporting allergic rhinitis (AR) in the UK birch pollen season from March to May. METHODS: Participants were UK adults reporting symptoms of spring time-AR (hayfever). They self-completed a diagnostic questionnaire in addition to undergoing an RTM comprising clinical history, skin prick testing to foods and pollens and oral food challenge. Subjects who reported anaphylaxis were excluded on the basis that they required specialist referral. RESULTS: One hundred and twenty three subjects took part in the study. Data from 110 participants were analysed; of the 13 exclusions, four provided insufficient data and nine reported anaphylaxis such that they warranted specialist assessment. Fifty-two participants (47%) were diagnosed with PFS by the RTM in comparison with 51 (46%) by a diagnostic questionnaire and algorithm (P=1.000, McNemar's test). The diagnostic questionnaire and algorithm had a sensitivity of 0.90 (0.78-0.96), a specificity of 0.93 (0.82-0.97), a positive predictive value of 0.92 (0.80-0.97) and a negative predictive value of 0.91 (0.80-0.96) when measured against the RTM. CONCLUSION AND CLINICAL RELEVANCE: The diagnostic questionnaire and algorithm is a practical and robust tool, which enables rapid identification, and therefore management, of individuals with PFS who experience rhino-conjunctivitis symptoms in the UK birch pollen season. Registered with CinicalTrials.Gov. registration number NCT00854958.

A comprehensive review of oral glucosamine use and effects on glucose metabolism in normal and diabetic individuals.

Glucosamine (GlcN) is a widely utilized dietary supplement that is used to promote joint health. Reports that oral GlcN supplementation at usual doses adversely affects glucose metabolism in subjects with impaired glucose tolerance have raised concerns that GlcN should be contraindicated in individuals with diabetes and those at risk for developing it. This review addresses its potential, when used at typical doses, to affect glucose metabolism and insulin sensitivity in healthy individuals and those with diabetes or 'pre-diabetes'. Publicly available scientific information and data on GlcN were systematically compiled using the electronic search tool, Dialog , and reviewed with special emphasis on human studies. In long-term clinical trials, including those containing subjects with type 2 diabetes or 'pre-diabetes', GlcN produced a non-significant lowering of fasting blood glucose concentrations in all groups of subjects treated for periods of up to 3 years. Owing to limitations in study design, conclusions based on studies that report adverse affects of GlcN on insulin sensitivity and glucose tolerance in pre-diabetic subjects are suspect. However, no definitive long-term studies of GlcN use for individuals with pre-diabetes are available. Nevertheless, based on available evidence, we conclude that GlcN has no effect on fasting blood glucose levels, glucose metabolism, or insulin sensitivity at any oral dose level in healthy subjects, individuals with diabetes, or those with impaired glucose tolerance.

Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial.

OBJECTIVES: To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible, intensive weight-loss program for 16 weeks. METHODS: Eligible patients were obese [body mass index (BMI)>30 kg/m(2)]; >50 years old, with primary knee OA. Participants were randomized to either a very-low-energy diet (VLED) or a low-energy diet (LED) (415 kcal/day and 810 kcal/day, respectively), using commercially available formula foods - only for the first 8 weeks, managed by dieticians. The 8 weeks were followed by an additional 8-week period of a hypo-energetic diet consisting of normal food plus meal replacements (1200 kcal/day). The primary endpoint was the number of patients responding according to the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responder criterion. The statistical analysis was based on a non-responder intention-to-treat (ITT) population (baseline observation carried forward). RESULTS: One hundred and ninety two patients (155 (80.7%) females) with a mean age 62.5 years [standard deviation (SD) 6.4; range 50-78 years]; average BMI 37.3 (SD 4.8) were included. At 16 weeks, similar proportions of the VLED and LED groups, 59 (61.5%), and 63 (65.6%) patients, respectively, met the OMERACT-OARSI responder criteria, with no statistical significant difference between the groups (P=0.55). Combining the groups the pooled estimate was 64% meeting the responder criteria [95% confidence interval (CI) 57%, 70%]. There was an overall reduction in pain, corresponding to an average pain reduction on the visual analogue scale (VAS) of 11.1 (95%CI 13.6, 8.5) in the combined groups. At week 16 weight loss in the combined groups was 12.8 kg (95%CI: 11.84-13.66; P<0.001). 71% lost > or =10% body weight in both diet groups, with a pooled estimate of 74% (95%CI: 68-80%). CONCLUSION: No clinically significant differences were found between the 415 kcal/day and 810 kcal/day diets. A 16-week formula-diet weight-loss program resulted in a fast and effective weight loss with very few adverse events resulting in a highly significant improvement in symptoms in overweight patients with knee OA.

Variations of Rayleigh Wave Phase Velocities across the Pacific Ocean.

Rayleigh wave phase velocities on paths crossing the Pacific Ocean show variations which are well correlated with some "average" lithospheric age of the region traversed. The seismic velocities in the upper mantle are highest in the oldest parts of the Pacific and lowest in the youngest parts.

Variations of Upper Mantle Structure under the Pacific Ocean.

The inversion of Rayleigh wave dispersion data for the Pacific Ocean shows that lithospheric thickness increases systematically with age. The lid to the low-velocity channel is very thin or absent near the ridge crest; the low-velocity channel may be absent in the oldest parts of the ocean.

The effect of a 12-week low glycaemic index diet on heart disease risk factors and 24 h glycaemic response in healthy middle-aged volunteers at risk of heart disease: a pilot study.

OBJECTIVE: To compare the effects of two energy-restricted healthy diets, one with a low GI and one with a high GI, on heart disease risk factors and weight loss in subjects at risk of heart disease. DESIGN: A 12-week randomized parallel study of low and high GI, healthy eating diets was carried out. SETTING: The study was carried out at the Hammersmith Hospital. SUBJECTS: Eighteen subjects were recruited by advertisement and randomized to one of the two diets. Fourteen completed the study but one was excluded from the final analysis. METHODS: At randomization, subjects were advised to follow the intervention diet for 12 weeks. Before randomization and on completion of the study, anthropometrics, fasting cholesterol and glucose blood tests and 24-h glucose measurements were taken using a continuous glucose monitoring system (CGMS). Statistical analysis was carried out using non-parametric tests. Median (IQR) are presented. RESULTS: A significantly different dietary GI was achieved in the low GI (median: 51.3 (IQR: 51.0-52.0) compared to the high GI (59.3 (59.2-64.0) (P=0.032) group. By week 12, both groups reduced their energy intake by: low GI group: (-)167 ((-)312-(-)123) kcal/day (P=0018) vs high GI group: (-)596 ((-)625-(-)516) (P=0.018) kcal/day, the difference between the groups being significant (P=0.010). However, only the low GI group lost weight ((-)4.0 ((-)4.4-(-)2.4) kg (P=0.018) whereas the high GI group did not significantly change in weight ((-)1.5 ((-)3.6-0.8) kg (P=0.463). By week 12, the low GI group also had a significantly lower 24-h area under the curve (AUC) (7556 (7315-8434) vs 8841 (8424-8846) mmol-h/l (P=0.045) and overnight AUC (2429 (2423-2714) vs 3000 (2805-3072) mmol-h/l (P=0.006) glucose as measured by CGMS. There were no differences in the other heart disease risk factors assessed. CONCLUSIONS: This pilot study provides some evidence that consuming a low GI diet in addition to weight loss and healthy eating may reduce cardiovascular risk. Other potential benefits of GI might have been masked by weight loss in the low GI group. Larger-scale studies need to follow.

Black tea--helpful or harmful? A review of the evidence.

OBJECTIVE: To consider whether consumption of black tea has a positive or negative impact on health. DESIGN: Databases were searched for relevant epidemiological and clinical studies published between 1990 and 2004. RESULTS: Clear evidence was found for coronary heart disease (CHD), where an intake of > or = 3 cups per day related to risk reduction. The mechanism could involve the antioxidant action of tea polyphenols. While experimental models have suggested that flavonoids attenuated cancer risk, epidemiological studies failed to demonstrate a clear effect for tea, although there is moderate evidence for a slightly positive or no effect of black tea consumption on colorectal cancer. Studies on cancer were limited by sample sizes and insufficient control of confounders. There is moderate evidence suggestive of a positive effect of black tea consumption on bone mineral density although studies were few. There is little evidence to support the effect of tea on dental plaque inhibition but evidence to support the contribution of tea to fluoride intakes and thus theoretical protection against caries. There was no credible evidence that black tea (in amounts typically consumed) was harmful. Normal hydration was consistent with tea consumption when the caffeine content was < 250 mg per cup. A moderate caffeine intake from tea appeared to improve mental performance, although sample sizes were small. There was no evidence that iron status could be harmed by tea drinking unless populations were already at risk from anaemia. CONCLUSIONS: There was sufficient evidence to show risk reduction for CHD at intakes of > or = 3 cups per day and for improved antioxidant status at intakes of one to six cups per day. A maximum intake of eight cups per day would minimise any risk relating to excess caffeine consumption. Black tea generally had a positive effect on health.

Acute effects of mycoprotein on subsequent energy intake and appetite variables.

The effect of mycoprotein, a food produced by continuous fermentation of Fusarium graminearum (Schwabe), on energy intake and appetite was investigated. Female subjects, all classified as nonrestrained eaters, participated in two 3-d study periods. Subjects weighed food consumed on the day before the study, on the day of the meal, and on the following day. Subjects were presented with an isoenergetic meal containing either mycoprotein or chicken and visual analogue scales were completed immediately premeal, postmeal, and at hourly intervals for 3 h. Energy intake was significantly reduced the day of the study (by 24%) and the next day (by 16.5%) after eating mycoprotein compared with chicken. When measured 3 h after consumption, prospective food consumption and desire to eat decreased after mycoprotein compared with chicken. Evidence is increasing that fiber can have an effect on appetite and we have demonstrated that fiber-containing mycoprotein also has this affect.

Mycoprotein reduces blood lipids in free-living subjects.

Mycoprotein is a food produced by continuous fermentation of Fusarium graminearum (Schwabe). A previous metabolic study showed that mycoprotein decreased total and low-density-lipoprotein (LDL) cholesterol and increased high-density-lipoprotein (HDL) cholesterol. This study was undertaken to determine the effects of mycoprotein under free-living conditions. Two groups of subjects with slightly raised cholesterol concentrations participated in the 8-wk study. The experimental group was fed cookies containing mycoprotein and the control group was fed a nutrient-balanced cookie without mycoprotein. After 8 wk of treatment total cholesterol was reduced by 0.46 mmol/L in the control group and 0.95 mmol/L in the mycoprotein group, and LDL was reduced by 0.34 mmol/L in the control group and 0.84 mmol/L in the mycoprotein group. All analysis of variance differences were statistically significant. This study confirms the metabolic-study results and we are now relatively confident that mycoprotein exerts a beneficial effect on blood lipids.

Effect of mycoprotein on blood lipids.

This metabolic study was designed to investigate the effects of mycoprotein on blood lipids. Mycoprotein is a food produced by continuous fermentation of Fusarium graminearum (Schwabe) on a carbohydrate substrate. Two groups of subjects with slightly raised cholesterol concentrations took part in the 3-wk study. The experimental group was fed mycoprotein in place of meat and the control diet contained meat. There was no change in plasma cholesterol in the control group but there was a 13% reduction in the mycoprotein group. Low-density lipoprotein (LDL) increased in the control group by 12% and decreased by 9% in the mycoprotein group. High-density lipoprotein (HDL) decreased by 11% in the control group but increased by 12% in the mycoprotein group. In each case the group ANOVA differences between variables were statistically significant. It is clear from these results that lipid variables are advantageously altered by mycoprotein consumption.

Dietary fiber and blood lipids: reduction of serum cholesterol in type II hyperlipidemia by guar gum.

Guar gum, a storage polysaccharide galactomannan and a form of dietary fiber, was administered to 10 patients with type II a or b hyperlipidemia for 2 weeks. Five grams of gum was given before each of three meals daily, either in a specially prepared soup or mixed with fruit juice or milk. No other deliberate change of diet was made. Three patients had been taking 12 to 16 g/day of cholestyramine for more than 2 years and one had been taking 1000 mg of clofibrate daily. These drugs were continued throughout the trial. Serum cholesterol levels of all 10 patients had been stable for 6 to 18 months before the trial at the start of which the mean level was 345 +/- 15 mg/dl. After 2 weeks of guar gum the mean was 308 +/- 16 mg/dl, a fall of 10.6% (P less than 0.01). Serum triglyceride was not changed significantly. Guar gum, which can be incorporated into foods, merits further study as a potential hypocholesterolemic agent.

Dietary fiber and blood lipids: treatment of hypercholesterolemia with guar crispbread.

Eleven hyperlipidemic patients took an average of 13 g guar in crispbread form over 2- to 8-week periods. Eight weeks' treatment (seven patients) reduced total serum cholesterol by 13% (P less than 0.002) while high-density lipoprotein cholesterol was unchanged. A 13% nonsignificant reduction was also seen in serum triglyceride. Comparison of blood lipid changes over 2-week periods showed guar crispbread to be as effective as guar given in hydrated (eight patients) or semihydrated form (four patients). In addition total serum cholesterol was lowered significantly (11%, P less than 0.05) in five patients where cholestyramine was ineffective. Due to its acceptability, guar crispbread is likely to prove a useful cholesterol-lowering agent.

Hypocholesterolemic action of dietary fiber unrelated to fecal bulking effect.

Twenty-two healthy volunteers took approximately 20 g/day of concentrated dietary fiber from either carrot, cabbage, apple, bran, or guar gum or 31 g from pectin, added for 3-week periods to controlled diets. Total serum cholesterol fell by 13% on both guar and pectin (P less than 0.01) with no significant change in high density lipoprotein cholesterol. Over the 3-week supplementation period, the other fibers were without effect with the exception of carrot, where both control and test high density lipoprotein levels fell (P less than 0.05 and less than 0.01, respectively). If, however, the 3rd week of the control was compared with the 3rd test week, the values for total cholesterol were 7% lower after apple (P less than 0.02) while after carrot the high density lipoprotein cholesterol level was 10% lower than the control (P less than 0.01). No significant change was seen in serum triglyceride or body weight either as judged by differences over the 3-week periods or by comparing test and control values at 3 weeks. Comparison of stool weights obtained in this study indicate that the fecal bulking action of dietary fiber is independent of its hypocholesterolaemic effect.

The antihypertensive effect of dietary supplementation with a 6-desaturated essential fatty acid concentrate as compared with sunflower seed oil.

There is increasing evidence that the type of fat in the diet may play a role in the control of blood pressure and development of hypertension. The purpose of the present study was to investigate the effect of a concentrated preparation of the 6-desaturated essential fatty acids gamma-linolenic acid (C18:3n-6), eicosapentaenoic acid (C20:5n-3) and docosahexaenoic acid (C22:6n-3) on individuals with raised BP. Eighteen volunteers from our College staff with elevated BP on several occasions but otherwise healthy, were divided into two groups following a two-week baseline period. One group received 4g sunflower seed oil daily and the other 4g of an oil preparation rich in C18:3n-6, C20:5n-3 and C22:6n-3 for six weeks. Major measurements included BP and fatty acids in phospholipids and cholesteryl esters. Dietary intakes and urinary fluid and electrolyte excretion were also monitored during baseline and intervention periods. The subjects' office diastolic BP showed a significantly greater effect of the concentrate over the sunflower seed oil, both overall (P = 0.03) and in interaction with time (P = 0.012). Fatty acids in plasma cholesteryl esters underwent mild alterations following the administration of the concentrate. There were no important changes in nutrient intakes or in sodium, potassium and fluid excretion during the trial period.

Resting blood pressure and cardiovascular reactivity to mental arithmetic in mild hypertensive males supplemented with blackcurrant seed oil.

The objective of this study was to test the effect of a supplement of blackcurrant seed oil (BSO), a rich source of gamma-linolenic acid (C18:3n-6) on the resting blood pressure (BP) and cardiovascular reactivity to a psychological stress in borderline hypertensive individuals. Twenty-seven male volunteers found to have a BP lying persistently within the borderline range, were allocated randomly to one of two groups at the end of a 4-week baseline period. The first group received a daily supplement of 6 g safflower oil for the consecutive 8 weeks while the second the same dose of blackcurrant seed oil. In addition to weekly measurements of resting BP, BP and heart rate reactivity to a standardised 5-min test of mental arithmetic were recorded before, and at the end of the supplementation period. BSO inhibited BP reactivity by over 40% (ANOVA for repeated measures diastolic (D) BP P = 0.026, systolic (S) BP P = 0.021). The decrease in DBP for the subjects on BSO was significantly different from the slight changes observed in the safflower group (ANOVA for repeated measures P = 0.018 for time-treatment interaction). We conclude that gamma-linolenic-rich fatty acid preparations are likely to influence cardiovascular control, by mechanisms yet to be clarified.

The relation of impaired vitamin A and E tolerance to fat absorption in biliary diversion.

Eleven patients have been studied after cholecystectomy with exploration of the common bile duct (CBD) and insertion of a T tube for free biliary drainage. Prior to clamping the T tube no significant rise was seen above fasting serum vitamin A and E, or serum triglyceride levels after 6 of the patients had been given these substances in a liquid test meal. In addition no rise in fasting vitamin E levels was seen after 3 subjects had been loaded for 4 days with 0.5 g DL alpha-tocopherol acetate/day. Faecal fat collections performed on 9 subjects indicated that over 70% of the ingested fat was absorbed. All these findings returned to normal when the T tube was clamped and the intraluminal flow of bile re-established. We conclude that deficiency of bile may allow the absorption of fat in the absence of fat soluble vitamins.

Formula food-reducing diets:A new evidence-based addition to the weight management tool box.

The changing pattern of obesity-related disease has created a need for a greater range of weight management options for the increasing number of people for whom weight loss and maintenance cannot be addressed by conventional dietary methods. Formula diet weight loss programmes [very low-calorie diets (VLCDs) (400-800 kcal/day) and low-calorie diets (LCDs) (800-1200 kcal/day)] can deliver weight loss at rates of 1-2 kg/week. This rate of weight loss can result in 10-20 kg weight loss in 8-12 weeks. Many health benefits associated with weight reduction seem to require between 10 and 20 kg weight loss. Formula diet programmes can result in weight loss, reduction of liver volume and reduction of visceral fat before bariatric surgery; weight loss before knee joint replacement surgery has also been shown. The benefit of pre-operative weight loss is still under investigation and such practices before bariatric surgery are variable in surgical units across the UK. Weight loss with formula diet in obesity-associated conditions where inflammation is an important component, such as osteoarthritis and psoriasis, has been demonstrated. Maintenance of about 10% of initial bodyweight loss, with symptom improvement in elderly obese people with knee osteoarthritis, has been shown over a period of 4 years. In obese people with psoriasis, weight loss with skin improvement has been maintained for 1 year. Clinical trials are currently underway to examine the merits of an initial weight loss with formula diet in pre-diabetes, in early type 2 diabetes and in insulin-treated type 2 diabetes. Rapid initial weight loss can result in rapid symptom improvement, such as reduced joint pain in osteoarthritis, improved sleep quality in obstructive sleep apnoea, reduced shortness of breath on exertion, reduced peripheral oedema and rapid improvement in metabolic control in diabetes, all changes that are highly motivating and conducive towards compliance. There is also some evidence for improved vitamin D status and maintained bone health in elderly obese people with osteoarthritis but more research is needed. Rapid initial weight loss was feared to be followed by rapid weight regain. However, provided initial weight loss is delivered in parallel with an intense education programme about nutrition, cooking, shopping and lifestyle for long-term maintenance; and where long-term support is provided, subsequent weight maintenance after VLCDs and LCDs has been shown to be possible. A recent literature review identified high-protein diets, obesity drugs and partial use of formula meal replacements as methods which can result in statistically significantly greater weight maintenance after initial weight loss with VLCDs or LCDs. Anxiety about serious adverse side effects seems to be unfounded although users need to be aware of both minor and more serious, though very infrequent, adverse events, such as gallstones and gallbladder disease.

Osteoarthritis, obesity and weight loss: evidence, hypotheses and horizons - a scoping review.

Obesity is widely acknowledged as a risk factor for both the incidence and progression of osteoarthritis, and has a negative influence on outcomes. Loss of at least 10% of body weight, coupled with exercise, is recognized as a cornerstone in the management of obese patients with osteoarthritis, and can lead to significant improvement in symptoms, pain relief, physical function and health-related quality of life. However, questions still remain surrounding optimal management. Given the significant health, social and economic burden of osteoarthritis, especially in obese patients, it is imperative to advance our knowledge of osteoarthritis and obesity, and apply this to improving care and outcomes. This paper overviews what is already known about osteoarthritis and obesity, discusses current key challenges and ongoing hypotheses arising from research in these areas, and finally, postulates what the future may hold in terms of new horizons for obese patients with osteoarthritis.

Improved nutritional status and bone health after diet-induced weight loss in sedentary osteoarthritis patients: a prospective cohort study.

BACKGROUND/OBJECTIVES: Obese subjects are commonly deficient in several micronutrients. Weight loss, although beneficial, may also lead to adverse changes in micronutrient status and body composition. The objective of the study is to assess changes in micronutrient status and body composition in obese individuals after a dietary weight loss program. SUBJECTS/METHODS: As part of a dietary weight loss trial, enrolling 192 obese patients (body mass index >30 kg/m2) with knee osteoarthritis (>50 years of age), vitamin D, ferritin, vitamin B12 and body composition were measured at baseline and after 16 weeks. All followed an 8-week formula weight-loss diet 415-810 kcal per day, followed by 8 weeks on a hypo-energetic 1200 kcal per day diet with a combination of normal food and formula products. Statistical analyses were based on paired samples in the completer population. RESULTS: A total of 175 patients (142 women), 91%, completed the 16-week program and had a body weight loss of 14.0 kg (95% confidence interval: 13.3-14.7; P<0.0001), consisting of 1.8 kg (1.3-2.3; P<0.0001) lean body mass (LBM) and 11.0 kg (10.4-11.6; P<0.0001) fat mass. Bone mineral content (BMC) did not change (-13.5 g; P=0.18), whereas bone mineral density (BMD) increased by 0.004 g/cm2 (0.001-0.008 g/cm2; P=0.025). Plasma vitamin D and B(12) increased by 15.3 nmol/l (13.2-17.3; P<0.0001) and 43.7 pmol/l (32.1-55.4; P<0.0001), respectively. There was no change in plasma ferritin. CONCLUSIONS: This intensive program with formula diet resulted in increased BMD and improved vitamin D and B12 levels. Ferritin and BMC were unchanged and loss of LBM was only 13% of the total weight loss. This observational evidence supports use of formula diet-induced weight loss therapy in obese osteoarthritis patients.

Comparison of a low-energy diet and a very low-energy diet in sedentary obese individuals: a pragmatic randomized controlled trial.

UNLABELLED: There is no consensus on whether 'very low-energy diets' (VLED; <800 kcal d(-1) ) cause greater weight loss in obese individuals than 'low-energy diets' (LED; 800-1200 kcal d(-1) ). The objective was to determine whether a very low-energy formula diet would cause greater weight loss than a formula 810 kcal d(-1) LED in older sedentary individuals. This is a pragmatic randomized controlled trial. INCLUSION CRITERIA: obesity (body mass index [BMI] > 30); age >50 years, with knee osteoarthritis. Participants were randomized to VLED (420-554 kcal d(-1) ) or LED (810 kcal d(-1) ) for 8 weeks, followed by a fixed-energy (1200 kcal d(-1) ) diet with food and two diet products daily for 8 weeks. In all, 192 participants were randomized. Mean age was 63 years (standard deviation: 6), mean weight 103.2 kg (15.0) and BMI of 37.3 kg m(-2) (4.8) at baseline. Mean weight losses in VLED and LED groups were 11.4 kg (standard error: 0.5) and 10.7 kg (0.5) at week 8 and 13.3 kg (0.7) and 12.2 kg (0.6) at week 16. Mean differences between groups were 0.76 kg (95% confidence interval: -0.59 to 2.10; P = 0.27) and 1.08 kg (-0.66 to 2.81; P = 0.22) at 8 and 16 weeks, respectively. Loss of lean body mass was 2.1 kg (0.2) and 1.2 kg (0.4) (17% and 11% of the weight lost, respectively) at week 16 in the VLED and LED group with a mean difference of 0.85 kg (0.01 to 1.69; P = 0.047). Significant adverse effects comparing VLED and LED, were bad breath: 34 (35%) vs. 21 (22%), intolerance to cold: 39 (41%) vs. 17 (18%) and flatulence: 43 (45%) vs. 28 (29%) for VLED and LED at 8 weeks (P < 0.05 in all cases). The VLED and LED regimens were equally successful in inducing weight loss. The significantly lower loss of lean tissue in the LED group together with more frequently reported side effects in the VLED group, favours the choice of low-energy diet (LED) for the treatment of obesity.