Is glycaemic control associated with dietary patterns independent of weight change in people newly diagnosed with type 2 diabetes? Prospective analysis of the Early-ACTivity-In-Diabetes trial.

BACKGROUND: It is unclear whether diet affects glycaemic control in type 2 diabetes (T2D), over and above its effects on bodyweight. We aimed to assess whether changes in dietary patterns altered glycaemic control independently of effects on bodyweight in newly diagnosed T2D. METHODS: We used data from 4-day food diaries, HbA1c and potential confounders in participants of the Early-ACTivity-In-Diabetes trial measured at 0, 6 and 12 months. At baseline, a 'carb/fat balance' dietary pattern and an 'obesogenic' dietary pattern were derived using reduced-rank regression, based on hypothesised nutrient-mediated mechanisms linking dietary intake to glycaemia directly or via obesity. Relationships between 0 and 6 month change in dietary pattern scores and baseline-adjusted HbA1c at 6 months (n = 242; primary outcome) were assessed using multivariable linear regression. Models were repeated for periods 6-12 months and 0-12 months (n = 194 and n = 214 respectively; secondary outcomes). RESULTS: Reductions over 0-6 months were observed in mean bodyweight (- 2.3 (95% CI: - 2.7, - 1.8) kg), body mass index (- 0.8 (- 0.9, - 0.6) kg/m2), energy intake (- 788 (- 953, - 624) kJ/day), and HbA1c (- 1.6 (- 2.6, -0.6) mmol/mol). Weight loss strongly associated with lower HbA1c at 0-6 months (ß = - 0.70 [95% CI - 0.95, - 0.45] mmol/mol/kg lost). Average fat and carbohydrate intakes changed to be more in-line with UK healthy eating guidelines between 0 and 6 months. Dietary patterns shifting carbohydrate intakes higher and fat intakes lower were characterised by greater consumption of fresh fruit, low-fat milk and boiled/baked potatoes and eating less of higher-fat processed meats, butter/animal fats and red meat. Increases in standardised 'carb/fat balance' dietary pattern score associated with improvements in HbA1c at 6 months independent of weight loss (ß = - 1.54 [- 2.96, - 0.13] mmol/mol/SD). No evidence of association with HbA1c was found for this dietary pattern at other time-periods. Decreases in 'obesogenic' dietary pattern score were associated with weight loss (ß = - 0.77 [- 1.31, - 0.23] kg/SD) but not independently with HbA1c during any period. CONCLUSIONS: Promoting weight loss should remain the primary nutritional strategy for improving glycaemic control in early T2D. However, improving dietary patterns to bring carbohydrate and fat intakes closer to UK guidelines may provide small, additional improvements in glycaemic control. TRIAL REGISTRATION: ISRCTN92162869 . Retrospectively registered on 25 July 2005.

James Lind Alliance research priorities: should diet and exercise be used as an alternative to drugs for the management of type 2 diabetes or alongside them?

AIM: To review evidence on whether diet and exercise should be used as an alternative to drug therapy for the management of type 2 diabetes or alongside. METHOD: We present a narrative review that draws on evidence from other systematic reviews and meta-analyses, narrative reviews, trials and cohort studies. We focused mainly on glycaemic control rather than control of blood pressure or cholesterol. RESULTS: Good-quality dietary advice that results in weight loss of >5% and physical activity interventions of >150 min/week of moderate to vigorous physical activity, combined with resistance exercise, can produce improvements in HbA1c similar to those produced by the addition of glucose-lowering drugs. These improvements can be seen at all stages of the disease. There are recognized interactions between glucose-lowering drugs and physical activity which may not be synergistic, but these are not well understood, and it is not clear if they are considered in clinical practice. Studies that explicitly compare drugs with diet or physical activity or control for drug use found that lifestyle could delay or reduce medication use, but most people eventually needed to progress to drug treatment. There are few studies, however, that provide strategies for the long-term maintenance of weight loss or physical activity. CONCLUSION: Diet and physical activity are of key importance in type 2 diabetes management, and attention to them improves glycaemic control and cardiovascular disease risk, but it is not yet known whether maintained lifestyle changes provide an alternative to drug therapy in the long term.

Provision of dietary advice for people with an ileostomy: a survey in the UK and Ireland.

AIM: The aim was to explore whether people with an ileostomy in the UK and Ireland receive the dietary advice they require. METHOD: An online survey with multiple-choice questions asked people with an ileostomy about the dietary advice they received and would have preferred to receive. Participants were recruited via websites of the Ileostomy and Internal Pouch Association and Crohn's and Colitis UK and via social media. People with a current ileostomy, age 16 years or over, and living in the UK or Ireland were eligible for inclusion. Responses were analysed using descriptive statistics. RESULTS: In all, 291 eligible responses were received and included in the analysis; 201 (69%) received advice on diet for their ileostomy from a healthcare professional or the internet. Of the 90 who did not receive dietary advice, 82 (91%) would have liked advice. Stoma nurses were the most common source of dietary advice (55%), but many other sources were frequently reported. Most (62%) felt that at least some dietary advice they received was conflicting. Over half (55%) felt anxious about managing their diet with a new ileostomy, 39% were confused, and 31% frustrated. Of 291 respondents, 29% received advice from a dietitian compared to 60% who would have preferred advice from a dietitian. CONCLUSION: Many people undergoing ileostomy surgery do not receive the dietary advice and support they require. Healthcare professionals working with people with an ileostomy should be mindful they are often anxious about their diet and require clear and consistent dietary advice and support.

Potential of electric bicycles to improve the health of people with Type 2 diabetes: a feasibility study.

AIM: To explore in a feasibility study whether 'e-cycling' was acceptable to, and could potentially improve the health of, people with Type 2 diabetes. METHODS: Twenty people with Type 2 diabetes were recruited and provided with an electric bicycle for 20 weeks. Participants completed a submaximal fitness test at baseline and follow-up to measure predicted maximal aerobic power, and semi-structured interviews were conducted to assess the acceptability of using an electric bicycle. Participants wore a heart rate monitor and a Global Positioning System (GPS) receiver in the first week of electric bicycle use to measure their heart-rate during e-cycling. RESULTS: Eighteen participants completed the study, cycling a median (interquartile range) of 21.4 (5.5-37.7) km per week. Predicted maximal aerobic power increased by 10.9%. Heart rate during electric bicycle journeys was 74.7% of maximum, compared with 64.3% of maximum when walking. Participants used the electric bicycles for commuting, shopping and recreation, and expressed how the electric bicycle helped them to overcome barriers to active travel/cycling, such as hills. Fourteen participants purchased an electric bicycle on study completion. CONCLUSIONS: There was evidence that e-cycling was acceptable, could increase fitness and elicited a heart rate that may lead to improvements in cardiometabolic risk factors in this population. Electric bicycles have potential as a health-improving intervention in people with Type 2 diabetes.

Changes in reported food intake in adults with type 2 diabetes in response to a nonprescriptive dietary intervention.

OBJECTIVES: There is a lack of published data about the food intake of patients with type 2 diabetes and the changes that they make in response to patient-centred dietary advice. The present study describes the changes reported in response to a nonprescriptive dietary intervention based upon UK dietary guidelines. METHODS: Two hundred and sixty-two patients (87 women and 175 men) from the Early ACTivity in Diabetes (ACTID) trial who received the dietary intervention returned 4 days food diaries at baseline and 6 months. Nonparametric tests were used to examine changes in meal patterns, total energy intake and energy from food groups between baseline and 6 months. RESULTS: Mean (SD) number of reported meals day(-1) was 3.0 (0.3) and mean (SD) number of snacks was 1.1 (0.6) at both baseline and 6 months for men and women. Men reported decreasing energy intake by a mean (SD) of 912 (1389) KJ/day [218 (332) kcal day(-1) ] (P < 0.001) and women by 515 (1130) KJ/day [123 (270) kcal day(-1) ] (P < 0.001). Men reported reducing energy from alcoholic drinks [-234 (527) KJ day(-1) ; P < 0.001], white bread [-113 (402) KJ day(-1) ; P = 0.001], biscuits [i.e. cookies -67 (205) KJ day(-1) ; P < 0.001] and cakes [-50 (410) KJ day(-1) ; P = 0.0012]. Women reported reducing energy from mixed main meals [-134 (456) KJ day(-1) ; P = 0.036], pasta and rice [-79 (326) KJ day(-1) ; P = 0.019], high-energy drinks [-59 (159) KJ day(-1) ; P = 0.001] and white bread [-59 (368) KJ day(-1) ; P = 0.042]. CONCLUSIONS: Men and women in the Early ACTID study reported small changes in higher-energy and lower-fibre foods and drinks in response to patient-centred dietary advice.

Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial.

BACKGROUND: Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations. METHODS: We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869. FINDINGS: Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups. INTERPRETATION: An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit. FUNDING: Diabetes UK and the UK Department of Health.

Oncofetal protein accompanying irradiation-induced small-bowel adenocarcinoma in the rat.

A tumor-associated protein was found in tissue derived from an X-irradiation-induced adenocarcinoma in the small bowel of the rat. The protein was associated with the cell membranes of the tumor tissue. It shared common antigenic determinants both with a rat fetal protein and a perchloric acid-soluble protein isolated from the serum of the tumor-bearing rat.

A systematic review of brief dietary questionnaires suitable for clinical use in the prevention and management of obesity, cardiovascular disease and type 2 diabetes.

The aim of this systematic review was to identify and describe brief dietary assessment tools suitable for use in clinical practice in the management of obesity, cardiovascular disease and type 2 diabetes. Papers describing development of brief (<35 items) dietary assessment questionnaires, that were accessible, simple to score and assessed aspects of the diet of relevance to the conditions of interest were identified from electronic databases. The development of 35 tools was described in 47 papers. Ten tools assessed healthy eating or healthy dietary patterns, 2 assessed adherence to the Mediterranean diet, 18 assessed dietary fat intake, and 5 assessed vegetable and/or fruit intake. Twenty tools were developed in North America. Test-retest reliability was conducted on 18 tools; correlation coefficients for total scores ranged from 0.59 to 0.95. Relative validation was conducted on 34 tools. The most common reference variable was percentage energy from fat (15 tools) and correlation coefficients ranged from 0.24, P<0.001 to 0.79, P<0.002. Tools that have been evaluated for reliability and/or relative validity are suitable for guiding clinicians when providing dietary advice. Variation in study design, settings and populations makes it difficult to recommend one tool over another, although future developers can enhance the understanding and use of tools by giving clear guidance as to the strengths and limitations of the study design. When selecting a tool, clinicians should consider whether their patient population is similar in characteristics to the evaluation sample.

Effect of methoxy substitution on the adrenergic activity of three structurally related alpha 2-adrenoreceptor antagonists.

We have recently reported the synthesis and alpha 2-antagonist activity of the methoxy derivative 2 [2-(2-methoxy-1,4-benzodioxan-2-yl)-2-imidazoline] and described the enhanced potency of this compound over the parent 1,4-benzodioxan, idazoxan, in reversing the inhibition caused by alpha 2-adrenoreceptor agonists of the electrically induced twitch in the rat or mouse vas deferens. It was of interest to us to discover whether a similar substitution in the structurally related alpha 2-adrenoreceptor antagonists piperoxan, prosympal, and fenmetazole would similarly enhance potency. We subsequently discovered that this was not so and potency was decreased markedly. In particular, that of the methoxy derivative of piperoxan was ca. 220 times less than the parent structure.

Alpha-adrenoreceptor reagents. 3. Synthesis of some 2-substituted 1,4-benzodioxans as selective presynaptic alpha 2-adrenoreceptor antagonists.

The synthesis and pharmacological activity of a series of 2-substituted derivatives of the selective alpha 2-adrenoreceptor antagonist idazoxan (RX 781094) is described. Substitution in this position by alkyl, alkenyl, cycloalkenyl, and alkoxy groups in many cases gives compounds whose potencies and selectivities are significantly greater than those of the parent compound.

Transpupillary irradiation of the rabbit retina with the cw-Nd:YAG laser. I. Acute morphologic effects produced using two different pulse forms.

The retinas of six pigmented rabbits (12 eyes) were irradiated with a cw-Nd:YAG laser using two different pulse forms, in conjunction with a constant pulse duration of 200 msec and a retinal focus diameter of 200 microns. The first pulse form (a) was characterized by an initial transient, lasting 15-20 msec, with a peak power twice that of the ensuing plateau phase of 180-185 msec. The second pulse form (b) was almost rectangular in shape. Although the average energies (and powers) for each pulse form were identical, almost 20% of this entity was delivered within the first 20 msec for the first pulse form. Impact lesions were examined at the biomicroscopic, light, and electron microscopic levels, and the characteristic morphologic features described for the cw-mode in general. Comparison of the effects produced using each pulse form revealed a number of differences. At low pulse energies (less than 150 mJ) the rectangular pulse form produced a photocoagulation reaction within the outer sensory retina, but when using the pulse form with the initial transient, this effect was superimposed by a degree of mechanical disruption. Ruptures produced within the elastic component of Bruch's membrane first appeared at lower pulse energies (ie, at 75 mJ, as opposed to 150 mJ for the rectangular pulse form) and were more frequent, and choroidal macrohemorrhaging (observed at pulse energies greater than or equal to 200 mJ) occurred only, when this latter pulse form was employed. Each of these phenomena may be attributed to the higher power and energy densities attained during the initial transient, which has disruptive properties. In order to avoid the risk of severe bleeding, these irradiation parameters should be maintained below approximately 6.4 X 10(3) W/cm2 and approximately 0.13 X 10(3) J/cm2.

Blood flow stasis induced by cw-Nd:YAG laser irradiation: comparative morphology of mesenteric and choroidal vessels in pigmented rabbits.

cw-Nd:YAG laser radiation was effective in producing blood flow stasis within arteries (35-40 microns in diameter) of pigmented rabbit mesentery (beam spot size: 80 microns; fluence: 2 x 10(4) J cm-2) and choroid (beam spot size: 200 microns; fluence: 6 x 10(2) J cm-2). However, the mechanism by which this was achieved differed in each case, and depended upon the energy absorbing structures present in the irradiated tissue. In non-pigmented tissue, such as the mesentery, haemoglobin represents the primary absorption centre, and the temperature attained within the vessel lumen (as inferred from morphological changes) is sufficient to denature plasma proteins, in particular fibrinogen, which consequently occlude the vessel lumen and arrest bleeding. In pigmented tissue, such as the choroid, melanocyte granules represent the primary absorption centre, which is thus shifted from the vessel lumen to the stroma. The temperature rise achieved within the vessel lumen is consequently lower, as evidenced by the absence of plasma protein denaturation. Blood flow stasis nonetheless occurs, but is triggered according to the normal haemostatic mechanism.

Morphologic findings in the rabbit retina following irradiation with the free-running neodymium-YAG laser. Disruption of Bruch's membrane and its effect on the scarring process in the retina and choroid.

The scarring process induced within the retina and choroid of pigmented rabbits' eyes following irradiation with the neodymium-YAG laser (working in the free-running mode) was examined at the ultrastructural level. Scarring of the sensory retina proceeded rapidly and was well advanced two weeks after irradiation, whereas in the choroid, signs of repair were apparent only after six weeks. This difference in the rate of repair between the two tissues has a bearing on the scarring pattern in the retinochoroid as a whole. The severity of damage to the elastic component of Bruch's membrane also has important consequences in relation to the repair processes in the retina and choroid. Microfractures within this layer, while enabling migrating cells of various kinds to penetrate into the inner collagenous zone, did not prevent complete regeneration of the retinal pigment epithelium (RPE). In instances of greater rupture, however, RPE regeneration was found to stop at the border of the break, and the discontinuity produced within Bruch's membrane and the RPE allowed the glial scar to expand into the choroid. In this region, new formation of vessels was not found.

Irradiation of rabbit retina with diode and Nd:YAG lasers.

AIMS: This study was carried out to compare the effects of continuous wave infrared laser radiation on pigmented and albino rabbit retinas at two wavelengths: 810 nm (diode) and 1064 nm (Nd:YAG). METHODS: Transpupillary laser pulses were applied with a spot size of 200 microns and durations of 200 ms (pigmented rabbits) and 0.5-1 s (albino rabbits). Light and electron microscopic analyses were performed immediately after exposure. RESULTS: In pigmented rabbits, threshold lesions were induced using a power of 100 mW with the diode and 200 mW with the Nd:YAG lasers. Damage was incurred by the retinal pigment epithelium with extension into the superficial and mid choroid posteriorly and into the outer retina anteriorly. In albino rabbits, lesions of comparable anteroposterior extension were identified using a power of 10 W with the Nd:YAG laser. Using diode laser irradiation, a maximum power output of 1.2 W failed to produce discernible lesions. CONCLUSIONS: The observed patterns of morphological damage are produced by complex tissue radiation interactions. In pigmented animals, this was primarily related to absorption of radiant energy by melanin within the retinal pigment epithelium and the choroidal melanocytes. In albino rabbits, laser induced effects occurred as a consequence of multiple scattering, together with absorption within haemoglobin and possibly also within tissue water. The data obtained provide further insight into the biological mechanisms arising from retinal photocoagulation with near infrared lasers.

Spontaneous and pharmacologically-modulated wound healing after Nd:YAG laser sclerostomy ab interno in rabbits.

UNLABELLED: The course of tissue repair evoked by Nd:YAG laser sclerostomy ab interno and the effect of mitomycin-C on same were investigated ultrastructurally in 15 rabbits. In ten of them, the dynamics of the spontaneous postoperative healing response (i.e. in the absence of medication) was analyzed at two-day intervals by light- and electron microscopy. In two, fibroblast activity was assessed autoradiographically. In the last three rabbits, the sclerostomy site was exposed transconjunctivally to mitomycin-C (0.5 mg/ml; 5 minutes) before surgery, and morphological analysis was done on postoperative days 6 and 12. RESULTS: In the spontaneously healing group, blebs disappeared within five days of surgery. This corresponded to a massive invasion of macrophages and fibroblasts from the episclera and iris root. The sheath of coagulated tissue around the fistula appeared to act as a barrier to cell migration from the sclera itself at this stage. By days 8 to 12, the canal had become occluded by a network of cells and capillaries, and collagen fibrils in the coagulation sheath had undergone repolymerization. In the mitomycin-C group, large filtering blebs and patent, cell-free fistulas were observed over the entire period. Although applied transconjunctivally, the drug penetrated the whole scleral depth, as the iris root and ciliary body cell reaction was inhibited. Repolymerization of heat-damaged collagen was also hindered. The overall findings provide information on the sequence of repair events following laser sclerostomy. Local, non-invasive application of mitomycin-C delays the onset of this process, not only by inhibition of cell proliferation but also by suppressing the collagen recovery.

Oculoplastic surgery with a contact Nd:YAG laser silica scalpel. A case report.

Baso-cellular carcinomas involving the medial canthal regions of both eyes were resected using a 10 W cw-Nd: YAG laser scalpel. The wound bed was repaired one side by a free, split-thickness graft and on the other by a frontal pedicle flap. Surgery was, for the most part, virtually bloodless. Since laser radiation immediately seals both capillaries and lymphatics, the incidence of postoperative hemorrhage and edema was significantly less than after cold scalpel surgery. Healing was uneventful. The advantages of laser-assisted surgery are worthy of consideration: not only is the operation time markedly curtailed, but the wound healing response is excellent, with only a minimal inflammatory reaction.

Morphological changes elicited in skeletal muscle by a Nd:YAG laser scalpel and electrocautery during surgical reduction of the human tongue.

A Nd:YAG laser scalpel was used for the surgical reduction of a human hyperplastic tongue. This instrument combines a fine cutting precision with haemostatic properties, whereby loss of blood is minimized and the surgeon's field of view unimpeded by flooding from the damaged capillary bed. The coagulative properties of Nd:YAG laser light are, however, insufficient to effect blood flow stasis in larger calibre vessels (arteries > 2 mm; veins > 3-5 mm), such as those located at the base of the tongue. For this purpose, bipolar diathermy (electrocautery) was employed. The ultrastructural changes incurred by skeletal muscle fibres using these two "heat" sources were compared. The damage profile elicited using each modality was similar: coagulation of myofilamentous proteins leads to destruction of fibrillar architecture with concomitant loss of periodic banding; on moving away from the wound margin, characteristic features are gradually restored. As the severity of these heat-induced effects decreases, there is a corresponding increase in superimposed dislocation and tearing phenomena induced by post-treatment swelling.

Laser cyclocoagulation.

Since its introduction in 1973 by Beckman and Sugar, cycloablation, using Nd: YAG laser energy has gained increasing attention. Nd: YAG laser energy may both be delivered in the contact and non-contact mode and the energy source may both work in the pulsed or cw mode. The physical and clinical effects of the various design principles differ. A short survey of the present state of the art is presented.

A new laser scalpel--a brief report.

One may consider the clad silica fibre cutting probe as a cheap alternative of the popular sapphire probe, sharing some of its properties. Made of silica, the scalpels have a fair heat tolerance and may be used without cooling by liquids or gas as is necessary with sapphire blades. The laser scalpel described here is driven (powered) with a 10 W cw Nd:YAG laser energy source (1064 nm) and possesses good cutting and haemostatic properties. It may also be used with lasers emitting other wavelengths. One may assume that a diode laser emitting in the near infrared (800-810 nm) may have very similar, although no analogous cutting properties when used with the described scalpel.

Dietary changes and associations with metabolic improvements in adults with type 2 diabetes during a patient-centred dietary intervention: an exploratory analysis.

OBJECTIVES: Describe dietary intake of participants enrolled in a non-prescriptive dietary intervention and dietary changes at 6 months and explore whether these changes had a role in observed improvements in glycated haemoglobin (HbA1c), weight, lipids and blood pressure. DESIGN: Secondary analysis of data from the Early ACTivity in Diabetes randomised controlled trial. PARTICIPANTS: 262 patients with newly diagnosed type 2 diabetes randomised to the dietary intervention. OUTCOMES AND ANALYSIS: Changes in energy intake, macronutrients, fibre and alcohol and in weight, waist circumference, lipids, HbA1c and blood pressure at baseline and 6 months. Multivariate models were used to examine associations between dietary changes and metabolic variables. RESULTS: Men reported reducing mean energy intake from 1903±462 kcal to 1685 kcal±439 kcal (p<0.001), increasing carbohydrate intake from 42.4±6.6% to 43.8±6.6% (p=0.002) and reducing median alcohol intake from 13 (0-27) g to 5 (0-18) g (p<0.001). Women reported reducing mean energy intake from 1582±379 kcal to 1459±326 kcal (p<0.001) with no change to macronutrient distribution and alcohol. Fibre intake was maintained. In men (n=148), weak and clinically insignificant associations were found between increased carbohydrates and reduction in HbA1c (ß=-0.003 (-0.006, -0.001); p=0.009), increased fibre and reduction in total cholesterol (ß=-0.023 (-0.044, -0.002); p=0.033), decreased total fat and reduction in low-density lipoprotein (LDL)-cholesterol (ß=0.024 (0.006, 0.001); p=0.011), and decreased alcohol and reduction in diastolic blood pressure (ß=0.276 (0.055, 0.497); p=0.015). In women (n=75), associations were found between a decrease in transfats and reductions in waist circumference (ß=-0.029 (0.006, 0.052); p=0.015), total cholesterol (ß=0.399 (0.028, 0.770); p=0.036) and LDL cholesterol (ß=0.365 (0.042, 0.668); p=0.028). CONCLUSIONS: Clinically important metabolic improvements observed in a patient-centred dietary intervention were not explained by changes in macronutrients. However, a non-prescriptive approach may promote a reduction in total energy intake while maintaining fibre consumption. TRIAL REGISTRATION NUMBER: The Early ACTID trial number ISRCTN92162869.