Development of an Aotearoa New Zealand adapted Mediterranean dietary pattern and Kai/food basket for the He Rourou Whai Painga randomised controlled trial.

Background: Following a Mediterranean diet (MedDiet) is associated with a lower risk of cardiovascular disease. He Rourou Whai Painga is a dietary intervention trial with behaviour change support that seeks to determine whether a MedDiet pattern can provide equivalent benefits in Aotearoa New Zealand (NZ), a country where cardiovascular disease is a leading cause of death. To do this, the MedDiet needs to be adapted in an acceptable way for NZ, with consideration of the Maori (indigenous) population. Methods: The MedDiet was defined using existing MedDiet scoring tools and adapted to the NZ context using local guidelines. The resulting NZ MedDiet pattern was used to develop a kai/food basket, including products from industry partners, for participants in He Rourou Whai Painga. Criteria set for the kai/food basket included providing up to 75% of energy requirements and falling within the Australia/NZ Acceptable Macronutrient Distribution Range to reduce risk of chronic disease. Maori researchers on the team provided support to ensure Matauranga Maori (Maori knowledge and values) was upheld through this process. Results: The NZ MedDiet pattern criteria was similar to the identified MedDiet scoring tools, with differences in recommendations for dairy, red meat, alcohol and olive oil. The resulting kai/food baskets were estimated to provide on average 73.5% of energy requirements for households, with 36% from fat, 8.6% from saturated fat, 17% protein, and 42% carbohydrate. Forty-two industry partners, including 3 Maori businesses, agreed to provide 22 types of food products towards the total. Conclusion: Small, feasible changes to the MedDiet can be made to align with the NZ guidelines and food environment. However, this eating pattern still differs from what the population, particularly Maori, are currently consuming. Continued partnership with Maori and additional behavioural support is important to facilitate adherence to this dietary pattern within He Rourou Whai Painga.Trial registration: https://www.anzctr.org.au/Default.aspx, identifier ACTRN12622000906752 and https://www.isrctn.com/, identifier ISRCTN89011056.

Glycaemic Response to a Nut-Enriched Diet in Asian Chinese Adults with Normal or High Glycaemia: The Tu Ora RCT.

Nut-based products are a good source of high-quality plant protein in addition to mono- and polyunsaturated fatty acids, and may aid low-glycaemic dietary strategies important for the prevention of type 2 diabetes (T2D). In particular, they may be advantageous in populations susceptible to dysglycaemia, such as Asian Chinese. The present study aimed to compare effects of a higher-protein nut bar (HP-NB, also higher in total fibre and unsaturated fats, comprising mixed almonds and peanuts) vs. an isoenergetic higher-carbohydrate cereal bar (HC-CB) within the diet of 101 Chinese adults with overweight and normo- or hyperglycaemia. Ectopic pancreas and liver fat were characterised using magnetic resonance imaging and spectroscopy (MRI/S) as a secondary outcome. Participants were randomized to receive HP-NB or HC-CB daily as a 1 MJ light meal or snack replacement, in addition to healthy eating advice. Anthropometry and clinical indicators of T2D risk were assessed fasted and during an oral glucose tolerance test (OGTT), pre- and post-intervention. No significant difference was observed between diet groups for body weight, body mass index, waist or hip circumference, blood pressure, glucoregulatory markers, lipid profile or inflammatory markers over 12 weeks (all, p > 0.05). No difference was observed between glycaemic subgroups or those with normal versus high ectopic organ fat. Although HP-NB can attenuate postprandial glycaemia following a meal, no effects were observed for either fasting or glucose-mediated outcomes following longer-term inclusion in the habitual diet of Chinese adults with overweight, including at-risk subgroups.

Effect of a Higher-Protein Nut versus Higher-Carbohydrate Cereal Enriched Diet on the Gut Microbiomes of Chinese Participants with Overweight and Normoglycaemia or Prediabetes in the Tu Ora Study.

Global increases in metabolic disorders such as type 2 diabetes (T2D), especially within Asian populations, highlight the need for novel approaches to dietary intervention. The Tu Ora study previously evaluated the effects on metabolic health of including a nut product into the diet of a New Zealand cohort of Chinese participants with overweight and normoglycaemia or prediabetes through a 12-week randomised, parallel-group clinical trial. In this current study, we compared the impact of this higher-protein nut bar (HP-NB) versus a higher-carbohydrate cereal bar (HC-CB) on the faecal microbiome by employing both 16S rRNA gene amplicon and shotgun metagenomic sequencing of pre- and post-intervention pairs from 84 participants. Despite the higher fibre, protein, and unsaturated fat content of nuts, there was little difference between dietary groups in gut microbiome composition or functional potential, with the bacterial phylum Firmicutes dominating irrespective of diet. The lack of observed change suggests the dietary impact of the bars may have been insufficient to affect the gut microbiome. Manipulating the interplay between the diet, microbiome, and metabolic health may require a more substantial and/or prolonged dietary perturbation to generate an impactful modification of the gut ecosystem and its functional potential to aid in T2D risk reduction.

A randomised controlled trial of additional bolus insulin using an insulin-to-protein ratio compared with insulin-to-carbohdrate ratio alone in people with type 1 diabetes following a carbohydrate-restricted diet.

AIMS: Postprandial hyperglycemia can be problematic for people with type 1 diabetes (T1DM) following carbohydrate-restricted diets. Bolus insulin calculated for meal protein plus carbohydrate may help. This study evaluated the effect of additional bolus insulin using an insulin-to-protein ratio (IPR) on glycaemic control. MATERIALS AND METHODS: Participants with T1DM aged ≥18-years were randomly allocated (1:1) to either carbohydrate and protein-based, or carbohydrate-based insulin dosing alone for 12 weeks while following a carbohydrate-restricted diet (50-100 g/day). Measurement of HbA1c and continuous glucose monitoring occurred at baseline and 12 weeks, with assessment of participant experience at 12 weeks. RESULTS: Thirty-four participants were randomised, 22 female, mean(SD): age 39.2 years (12.6) years; diabetes duration 20.6 years (12.9); HbA1c 7.3 % (0.8), 56.7 mmol/mol (9.2). Seven in each group used insulin pump therapy. HbA1c reduced at 12 weeks with no difference between treatments: mean (SD) control 7.2 % (1.0), 55.7 mmol/mol (10.6); intervention 6.9 % (0.7), 52.3 mmol/mol (7.2) (p = 0.65). Using additional protein-based insulin dosing compared with carbohydrate alone, there was no difference in glycaemic variability, time spent in euglycemic range (TIR), or below range. Participants using IPR reported more control of their diabetes, but varying levels of distress. CONCLUSIONS: Additional bolus insulin using an IPR did not improve glycaemic control or TIR in patients with well controlled T1DM following a carbohydrate-restricted diet. Importantly, the use of the IPR does not increase the risk of hypoglycemia and may be preferred.

A high quality Aotearoa New Zealand dietary pattern adapting a Mediterranean diet for metabolic health: a feasibility study.

AIM: To assess the feasibility of a family-based dietary intervention study using a meal kit home delivery service, in people at risk of cardio-metabolic disease. METHODS: A 12-week dietary intervention feasibility study of adults (termed the index participants) at increased risk of metabolic and cardiovascular disease, enriched for Maori who are indigenous New Zealanders. The study sample also included the household/whanau members living with the index participant. All participants received a 12 week intervention using weekly home delivery of meal kits and groceries consistent with a Mediterranean dietary pattern. Outcomes were the metabolic syndrome severity score (MetSSS); feasibility and acceptability of the intervention; dietary intake; and other clinical and anthropometric measures. RESULTS: There were 29 index participants recruited and in addition, 50 household/whanau members took part in the feasibility study. The mean (SD) household/whanau size was 3.45 (1.4) people, and the mean (SD) number of people in each household/whanau who participated in the study was 2.84 (1.2). The feasibility of intervention to households/whanau was proven in this context. The mean (SD) change in MetSSS was 0.03 (0.33), N = 27, P = 0.69 and there was a statistically significant decrease in body weight of 1.37 kg (95% CI 0.11 to 2.62), p = 0.034. The food deliveries were well received, the dinner kits more so than the grocery items. CONCLUSION: It is feasible to recruit individuals and households/whanau to a family-based dietary intervention. Use of a meal kit home delivery service to provide food which is consistent with the intervention dietary pattern was well received. This feasibility study identified improvements to be made such as nutrition behaviour change support, more variety in food provided, more recipes, and better matching of food quantity to family size. TRIAL REGISTRATION: ANZCTR-ACTRN12621000856819p registered 2.JUN.2021 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382021&isReview=true.

He Rourou Whai Painga, an Aotearoa New Zealand dietary pattern for metabolic health and whanau wellbeing: protocol for a randomized controlled trial.

Background: Cardiometabolic diseases are highly prevalent in Aotearoa New Zealand. Dietary intake is a modifiable risk factor for such diseases and certain dietary patterns, specifically the Mediterranean diet (MedDiet), are associated with improved metabolic health. This study aims to test whether an intervention including a Mediterranean dietary pattern incorporating high quality New Zealand foods (NZMedDiet pattern) and behavior change science can improve the metabolic health of participants and their household/whanau. Methods and analysis: This is a multi-center, three-stage trial with two parallel group superiority randomized controlled trials (RCTs), and a longitudinal cohort study embedded within the trial design. The first RCT (RCT 1) is a comparison of the NZMedDiet pattern compared to usual diet for 12 weeks. The Behavior Change Wheel was used to select and implement strategies to support participant adherence to the NZMedDiet, such as web-based nutrition education on healthy shopping and cooking. The second (RCT 2) compares online social support to no online social support for 12 weeks, administered to participants immediately following RCT 1. The third stage is a longitudinal cohort study where all participants are followed from the beginning of their start of the active intervention for 12 months in total. The primary outcome measure for each stage is the metabolic syndrome severity score (MetSSS). The duration of enrolment is 12-15 months. The total recruitment target is 200 index participants and their household/whanau members who participate with them, and the primary analyses will be intention to treat on index participants. Discussion: The trial will test whether the NZMedDiet pattern and behavior change support improves the cardiometabolic health of people in Aotearoa New Zealand. Clinical trial registration: https://www.anzctr.org.au/Default.aspx, identifier ACTRN12622000906752 and https://www.isrctn.com/, identifier ISRCTN89011056 (Spirit 2).

Very low carbohydrate (ketogenic) diets in type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.

AIM: Very low carbohydrate/ketogenic diets (VLC/KDs) are popular but their role in managing pre-diabetes and type 2 diabetes (T2D) is uncertain. This study uses a systematic review and meta-analysis of randomized controlled trials to estimate the effect of these diets in this population. MATERIALS AND METHODS: A systematic review identified randomized controlled trials of at least 6 months duration comparing efficacy and safety of VLC/KDs (≤50 g carbohydrate or ≤10% total energy from carbohydrate per day) with a control diet (carbohydrate above the VLC/KD threshold) in adults with pre-diabetes or T2D. The primary outcome variable was glycated haemoglobin (HbA1c) after 12 months. The meta-analysis method was inverse variance weighting of mean values for continuous variables. RESULTS: Key word searches identified 2290 studies; 2221 were not in scope. A full text review of 69 studies identified eight meeting inclusion criteria; in total, it involved 606 participants. Six studies reported HbA1c (%) at 12 months; four as change from baseline with a fixed effects estimate (95% confidence interval): VLC/KD minus control of 0.01% (-0.22 to 0.25), p = .91; and two as change from baseline: -0.65% (-0.99; -0.31) [-7.1 mmol/mol (-10.8; -3.4)], p < .001. Serum triglycerides were lower with VLC/KD versus control: -0.28 mmol/L (-0.44 to -0.11), p < .001. High-density lipoprotein was higher with an estimate of 0.04 mmol/L (0.01 to 0.08), p = .03, in the five studies reporting 12-month summary data. CONCLUSIONS: A VLC/KD may cause reductions in HbA1c and triglycerides in those with pre-diabetes or T2D but evidence of an advantage over other strategies is limited. More well-designed studies are required to provide certain evidence.

A randomised controlled trial of a probiotic and a prebiotic examining metabolic and mental health outcomes in adults with pre-diabetes.

AIMS: To evaluate the effect of the probiotic Lactobacillus rhamnosus HN001 and/or cereal enriched with oat-derived beta-glucan (OBG) on metabolic and mental health outcomes when administered to adults with pre-diabetes. DESIGN: 2×2 factorial design randomised, parallel-groups placebo-controlled; double-blinded for probiotic, single-blinded for cereals. PARTICIPANTS: Community-dwelling adults aged 18-80 years with pre-diabetes: glycated haemoglobin (HbA1c) 41-49 mmol/mol. INTERVENTIONS: Capsules containing Lactobacillus rhamnosus (HN001) (6×109 colony-forming units/day), or placebo capsules; and cereal containing 4 g/day OBG or calorie-matched control cereal, taken daily, for 6 months. Study groups were: (A) HN001 capsules+OBG cereal; (B) HN001 capsules+control cereal; (C) placebo capsules+OBG cereal and (D) placebo capsules+control cereal. OUTCOME MEASURES: Primary outcome: HbA1c at 6 months. SECONDARY OUTCOMES: fasting plasma glucose, fasting insulin, homeostatic model assessment of insulin resistance, fasting lipids, blood pressure, body weight, waist circumference, body mass index and mental well-being. RESULTS: 153 participants were randomised. There was complete HbA1c outcome data available for 129 participants. At 6 months the mean (SD) HbA1c was 45.9 (4.4) mmol/mol, n=66 for HN001, and 46.7 (4.3) mmol/mol, n=63 for placebo capsules; 46.5 (4.0) mmol/mol, n=67 for OBG and 46.0 (4.6) mmol/mol n=62 for control cereal. The estimated difference between HN001-placebo capsules was -0.83, 95% CI -1.93 to 0.27 mmol/mol, p=0.63, and between OBG-control cereals -0.17, 95% CI -1.28 to 0.94 mmol/mol, p=0.76. There was no significant interaction between treatments p=0.79. There were no differences between groups or significant interactions between treatments for any of the secondary outcomes. CONCLUSIONS: This study found no evidence of clinical benefit from the supplementation with either HN001 and/or cereal containing 4 g OBG on HbA1c and all secondary outcomes relevant to adults with pre-diabetes. TRIAL REGISTRATION NUMBER: Australian New Zealand Clincial Trials Registry number ACTRN12617000990325.

Potential Association Between Dietary Fibre and Humoral Response to the Seasonal Influenza Vaccine.

Influenza vaccination is an effective public health measure to reduce the risk of influenza illness, particularly when the vaccine is well matched to circulating strains. Notwithstanding, the efficacy of influenza vaccination varies greatly among vaccinees due to largely unknown immunological determinants, thereby dampening population-wide protection. Here, we report that dietary fibre may play a significant role in humoral vaccine responses. We found dietary fibre intake and the abundance of fibre-fermenting intestinal bacteria to be positively correlated with humoral influenza vaccine-specific immune responses in human vaccinees, albeit without reaching statistical significance. Importantly, this correlation was largely driven by first-time vaccinees; prior influenza vaccination negatively correlated with vaccine immunogenicity. In support of these observations, dietary fibre consumption significantly enhanced humoral influenza vaccine responses in mice, where the effect was mechanistically linked to short-chain fatty acids, the bacterial fermentation product of dietary fibre. Overall, these findings may bear significant importance for emerging infectious agents, such as COVID-19, and associated de novo vaccinations.

Distinct Dysfunctional States of Circulating Innate-Like T Cells in Metabolic Disease.

The immune system plays a significant role in controlling systemic metabolism. Innate-like T (ILT) cells in particular, such as mucosal-associated invariant T (MAIT) cells, invariant natural killer T (iNKT) cells and γδ T cell receptor expressing cells, have been reported to promote metabolic homeostasis. However, these different ILT cell subsets have, to date, been generally studied in isolation. Here we conducted a pilot study assessing the phenotype and function of circulating MAIT, iNKT, and Vδ2+ T cells in a small cohort of 10 people with obesity and type 2 diabetes (T2D), 10 people with obesity but no diabetes, and 12 healthy individuals. We conducted phenotypic analysis by flow cytometry ex vivo, and then functional analysis after in vitro stimulation using either PMA/ionomycin or synthetic agonists, or precursors thereof, for each of the cell-types; use of the latter may provide important knowledge for the development of novel therapeutics aimed at activating human ILT cells. The results of our pilot study, conducted on circulating cells, show clear dysfunction of all three ILT cell subsets in obese and obese T2D patients, as compared to healthy controls. Importantly, while both iNKT and Vδ2+ T cell dysfunctions were characterized by diminished IL-2 and interferon-γ production, the distinct dysfunctional state of MAIT cells was instead defined by skewed subset composition, heightened sensitivity to T cell receptor engagement and unchanged production of all measured cytokines.

Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and ß-glucan to improve glycated haemoglobin, metabolic health, and general well-being in adults with pre-diabetes: study protocol for a 2 × 2 factorial design, parallel group, placebo-controlled randomized controlled trial, with embedded qualitative study and economic analysis.

BACKGROUND: The rates of pre-diabetes and type 2 diabetes mellitus are increasing worldwide, producing significant burdens for individuals, families, and healthcare systems. In New Zealand, type 2 diabetes mellitus and pre-diabetes disproportionally affect Maori, Pacific, and South Asian peoples. This research evaluates the efficacy, acceptability, and economic impact of a probiotic capsule and a prebiotic cereal intervention in adults with pre-diabetes on metabolic and mental health and well-being outcomes. METHODS: Eligible adults (n = 152) aged 18-80 years with pre-diabetes (glycated haemoglobin 41-49 mmol/mol) will be enrolled in a 2 × 2 factorial design, randomised, parallel-group, placebo-controlled trial. Computer-generated block randomization will be performed independently. Interventions are capsulated Lactobacillus rhamnosus HN001 (6 × 109 colony-forming units/day) (A) and cereal containing 4 g ß-glucan (B), placebo capsules (O1), and calorie-matched control cereal (O2). Eligible participants will receive 6 months intervention in the following groups: AB, AO1, BO2, and O1O2. The primary outcome is glycated haemoglobin after 6 months. Follow-up at 9 months will assess the durability of response. Secondary outcomes are glycated haemoglobin after 3 and 9 months, fasting glucose, insulin resistance, blood pressure, body weight, body mass index, and blood lipid levels. General well-being and quality of life will be measured by the Short-Form Health Survey 36 and Depression Anxiety Stress Scale 21 at 6 and 9 months. Outcome assessors will be blind to capsule allocation. An accompanying qualitative study will include 24 face-to-face semistructured interviews with an ethnically balanced sample from the ß-glucan arms at 2 months, participant focus groups at 6 months, and three health professional focus groups. These will explore how interventions are adopted, their acceptability, and elicit factors that may support the uptake of interventions. A simulation model of the pre-diabetic New Zealand population will be used to estimate the likely impact in quality-adjusted life years and health system costs of the interventions if rolled out in New Zealand. DISCUSSION: This study will examine the efficacy of interventions in a population with pre-diabetes. Qualitative components provide rich description of views on the interventions. When combined with the economic analysis, the study will provide insights into how to translate the interventions into practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000990325. Prospectively registered on 10 July 2017.

The effect of additional mealtime insulin bolus using an insulin-to-protein ratio compared to usual carbohydrate counting on postprandial glucose in those with type 1 diabetes who usually follow a carbohydrate-restricted diet: A randomized cross-over trial.

This randomized controlled cross-over study compared postprandial glucose concentrations and incidence of hypoglycaemia for mealtime bolus insulin calculated for both meal protein and carbohydrate content, with ordinary dosing for carbohydrate content alone, in adults with type 1 diabetes who usually follow a carbohydrate-restricted diet. All 16 participants completed three test meals under each of the two conditions. The primary outcome was the time normalized Area Under the Curve (AUC) of glucose measurements. The mean (SD) AUC glucose concentration for insulin dosing for both protein and carbohydrate was 8.3 (2.1) mmol/L compared with 10.0 (2.2) mmol/L for carbohydrate alone. The difference (95% CI) was -1.76 mmol/L (-2.87 to -0.65), P = .003. The mean (SD) glucose concentration ≥ 8.0 mmol/L was 54.8 (32.4)% for dosing for protein and carbohydrate and 73.7 (26.3)% for carbohydrate alone, rate ratio (95% CI) 0.75 (0.62 to 0.89), P = .002. For glucose concentration < 4.0 mmol/L 5.5 (15.1)% and 2.8 (11.7)%; rate ratio (95% CI): 1.97 (0.90 to 4.27), P = .087. Calculating the meal insulin requirements based on the carbohydrate and protein content may have advantages over calculations based on carbohydrate alone. Further studies are required to determine how to best optimize this.

A feasibility study: association between gut microbiota enterotype and antibody response to seasonal trivalent influenza vaccine in adults.

Objective: We investigated the potential feasibility of a randomized controlled trial of a nutritional intervention that may alter human gut microbiota and support immune defence against respiratory tract infection in adults (Proposed Study). Methods: In total, 125 healthy adults aged 18-64 participated in a 6-month study that measured antibody response to the seasonal trivalent influenza vaccine. We assessed completion rates, procedure adherence rates and the influence of possible exclusion criteria on potential recruitment into the Proposed Study. We examined whether the gut microbiota could be categorised into enterotypes, and whether there was an association between enterotypes and the antibody response to the influenza vaccine. Results: The participant completion rate was 97.6% (95% CI 93.1-99.5%). The proportions (95% CI) of participants who may be excluded for antibiotic or corticosteroid use in the 30 days prior to the study, or due to receiving the influenza vaccine in the previous two years were 9.6% (5.1-16.2), 8.0% (3.9-14.2) and 61.6% (52.5-70.2), respectively. All participants were stratified into four gut microbiota enterotypes. There was no association between these enterotypes and the antibody response to the influenza vaccine, although the study was not powered for this outcome. Conclusion: This study design is suitable for the Proposed Study. The completion rate is likely to be high, although exclusion criteria should be selected with care. Further analyses of gut microbiota composition or function in association with antibody and immune responses are warranted to explore the role of host-microbiota interactions on protective immunity.

Development of a structured diabetes self-management education program specific to the cultural and ethnic population of New Zealand.

AIM: To develop and pilot a diabetes self-management education (DSME) program specific to the needs of New Zealanders with type 2 diabetes mellitus (T2DM). METHODS: There were two parts in the present study. The first was the development of the program. This involved a literature review, consultation with end-user groups and drafting the content of the program. In the second part, the program was tested and modified according to feedback provided by both participants and facilitators. RESULTS: The present study achieved its primary goal of developing, piloting and modifying a DSME program specific to the New Zealand population. The DSME program was developed using concepts and content of international DSME programs. The content and concept was extensively tested via discussion groups with 71 individuals with T2DM and practice nurses to ensure the program met the unique cultural needs of New Zealanders with T2DM. Twenty-seven participants with T2DM were recruited into the pilot, of which 13 attended four of six sessions. Feedback from participants, observing nurses and facilitators was incorporated into the final program. CONCLUSIONS: DSME programs are an effective vehicle for providing individuals with T2DM the initial information and support to start self-managing their diabetes. However, to ensure DSME programs help individuals with the highest rates of diabetes and diabetes-related complications, it is important end-users participate in the development of the program. This DSME program now requires longitudinal trial to determine if in the New Zealand context it is able generate the same improvements in both clinical and qualitative outcomes as seen in similar international programs.

Sublingual vitamin B12 compared to intramuscular injection in patients with type 2 diabetes treated with metformin: a randomised trial.

UNLABELLED: MAIM: To compare a single 1mg intramuscular hydroxocobalamin injection with a 3-month course of 1mg/day sublingual methylcobalamin supplements on serum vitamin B12 concentrations in participants withtype 2 diabetes treated with metformin. METHOD: Participants on metformin treatment with vitamin B12 concentrations below 220pmol/L were recruited through hospital diabetes clinics and primary care practices. They were randomised to receive either the injection or sublingual treatment. The primary outcome was serum vitamin B12 level after 3 months adjusted for baseline assessed by analysis of covariance (ANCOVA). The trial was registered on the Australia New Zealand Clinical Trial registry (ACTRN12612001108808). RESULTS: A total of 34 participants were randomised; 19 to the tablet, and 15 to the injection. The mean (SD) age, duration of diabetes, and duration of metformin use were, 64.2 (7.3) years, 13.7 (6.4) years, and 11.6 (5.0) years, respectively. After 3 months, the mean (SD) vitamin B12 was 372.1 (103.3) pmol/L in the tablet group (n=19) compared to 251.7 (106.8) pmol/L in the injection group (n=15), ANCOVA estimated difference -119.4 (95% CI -191.2 to -47.6), p=0.002. After 6 months, the mean (SD) serum B12 was 258.8 (58.7) pmol/L in the tablet group (n=17) and 241.9 (40.1) pmol/L in the injection group (n=15); ANCOVA estimated difference -15.2 (95% CI -50.3 to 19.8), p=0.38. Higher metformin dose was associated with lower serum B12 at 3 months, but not at baseline or 6 months. CONCLUSION: Decreased serum vitamin B12 level in patients with type 2 diabetes who are treated with metformin can be corrected through treatment with either hydroxocobalamin injections or methylcobalamin sublingual supplements.

A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account.

BACKGROUND AND OBJECTIVES: To determine the effect of a low carbohydrate diet and standard carbohydrate counting on glycaemic control, glucose excursions and daily insulin use compared with standard carbohydrate counting in participants with type 1 diabetes. METHODS AND STUDY DESIGN: Participants (n=10) with type 1 diabetes using a basal; bolus insulin regimen, who attended a secondary care clinic, were randomly allocated (1:1) to either a standard carbohydrate counting course or the same course with added information on following a carbohydrate restricted diet (75 g per day). Participants attended visits at baseline and 12 weeks for measurements of weight, height, blood pressure, HbA1c, lipid profile and creatinine. They also completed a 3-day food diary and had 3 days of continuous subcutaneous glucose monitoring. RESULTS: The carbohydrate restricted group had significant reductions in HbA1c (63 to 55 mmol/mol (8.9-8.2%), p<0.05) and daily insulin use (64.4 to 44.2 units/day, p<0.05) and non-significant reductions in body weight (83.2 to 78.0 kg). There were no changes in blood pressure, creatinine or lipid profile and all outcomes in the carbohydrate counting group were unchanged. There was no change in glycaemic variability as measured by the mean amplitude of glycaemic excursion in either group. CONCLUSIONS: A low carbohydrate diet is a feasible option for people with type 1 diabetes, and may be of benefit in reducing insulin doses and improving glycaemic control, particularly for those wishing to lose weight.

The effect of a cinnamon-, chromium- and magnesium-formulated honey on glycaemic control, weight loss and lipid parameters in type 2 diabetes: an open-label cross-over randomised controlled trial.

PURPOSE: This randomised controlled trial assessed the acute and long-term effects of daily supplementation of kanuka honey, formulated with cinnamon, chromium and magnesium on glucose metabolism, weight and lipid parameters in individuals with type 2 diabetes. METHODS: Twelve individuals with type 2 diabetes received 53.5 g of a formulated honey and a control (non-formulated) kanuka honey in a random order for 40 days, using cross-over design. Fasting glucose, insulin, HbA1c, lipids and anthropometric measures were measured at baseline and end of treatment. A meal tolerance test was performed at baseline to assess acute metabolic response. RESULTS: There was no statistically significant difference in acute glucose metabolism between treatment groups, as measured by the Matsuda index and AUC for glucose and insulin. After the 40-day intervention with honey, fasting glucose did not differ significantly between the two treatments (95 % CI -2.6 to 0.07). There was no statistically significant change in HbA1c or fasting insulin. There was a statistically significant reduction in total cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23), LDL cholesterol by -0.29 mmol/L (95 % CI -0.57 to -0.23) and weight by -2.2 kg (95 % CI -4.2 to -0.1). There was a trend towards increased HDL and reduced systolic blood pressure in the intervention treatment. CONCLUSION: The addition of cinnamon, chromium and magnesium supplementation to kanuka honey was not associated with a significant improvement in glucose metabolism or glycaemic control in individuals with type 2 diabetes. Use of the formulated honey was associated with a reduction in weight and improvements in lipid parameters, and should be investigated further.

From 'pleasure to chemistry': the experience of carbohydrate counting with and without carbohydrate restriction for people with Type 1 diabetes.

INTRODUCTION: Matching carbohydrate intake with insulin dosage is recommended management for people with Type 1 diabetes. However, international interest in restricted carbohydrate diets is growing. General practitioners and practice nurses need to know how to advise people with Type 1 diabetes regarding low-carbohydrate diets. This study aimed to explore the carbohydrate counting experiences of people with Type 1 diabetes in a trial with and without a diet restricted to 75 g of carbohydrate per day. METHODS: Eight participants were interviewed by focus group or interview 12 weeks after a carbohydrate counting course with individual dietary choice or the same course with information on restricted carbohydrate eating and a daily maximum intake of 75 g of carbohydrate. Data were analysed using a qualitative thematic analysis approach. FINDINGS: Themes included the need for insulin management skills, impact of the dietary experience, and need for dietary knowledge. The restricted-carbohydrate group encountered mealtime insulin resistance and difficulty managing insulin dosages when transitioning on and off the low-carbohydrate diet. The diet impacted on mood, feelings of satiety and it was reported that food changed from being 'a pleasure to chemistry'. Both groups described feeling empowered to manage their diabetes as a result of the carbohydrate counting course. CONCLUSION: Participants reported increased knowledge and challenging insulin management. The restricted-carbohydrate group reported mealtime insulin resistance and a strong dietary impact. Extra health professional support may be required, especially at dietary transition periods. More research is warranted into the reported mealtime insulin resistance.

Should support for obesity interventions or perceptions of their perceived effectiveness shape policy?

OBJECTIVES: Most studies suggest the public locate responsibility for the 'obesity epidemic' with individuals themselves and support measures promoting greater personal responsibility in the belief these will reduce obesity prevalence. We compared estimates of policy support with estimates of perceived policy effectiveness to test this assumption. METHODS: In an on-line survey of 534 New Zealanders, we tested support for 15 potential measures to reduce overweight and obesity and compared this with estimates of the effectiveness of these policies, determined by a Best-Worst choice experiment. RESULTS: Respondents gave strongest support to measures encouraging people to undertake more exercise and adopt a better diet. However, they saw greater personal responsibility as less effective in reducing obesity than environmental interventions that reduced the costs of healthy food and exercise, and decreased the availability of unhealthy foods. CONCLUSIONS: Potentially important differences exist between the measures the general public say they support to address obesity, which favour personal responsibility and education, and those they believe will be effective, which include more environmental interventions. IMPLICATIONS: Simply measuring the popularity of measures to reduce obesity produces an incomplete picture of public opinion. Examining the perceived efficacy of different interventions offers a complementary perspective that policy makers should also consider.

The prevalence of low vitamin B12 status in people with type 2 diabetes receiving metformin therapy in New Zealand--a clinical audit.

AIM: Metformin, the most common hypoglycaemic agent used in type 2 diabetes, is associated with reduced serum vitamin B12 concentrations. This cross sectional observational study determines the prevalence of low vitamin B12 status in people with type 2 diabetes on metformin therapy in both primary and secondary care in New Zealand. METHOD: All eligible patients seen in a secondary-care clinic over a 15-month timeframe were screened for low serum vitamin B12 concentrations. Additionally, patients from four primary health care providers were identified using metformin prescription data and offered the chance to participate in the audit. RESULTS: Prevalence of serum Vitamin B12 level <220 pmol/L was 18.7%. Positive correlations were observed between B 12 concentration, age and dosage and duration of metformin treatment. Maori and Pacific Islanders had higher mean serum B12 concentrations than Europeans but no difference in prevalence of low serum B12 concentrations. CONCLUSION: Low serum B12 concentration is a common occurrence in people with type 2 Diabetes treated with Metformin. Age is an important factor which explains some of this association. Systematic screening in those receiving metformin is advisable, particularly for patients older than 50 years.