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.

Cost-effectiveness of soluble beta-glucan gel in hard-to-heal wounds: an evaluation.

OBJECTIVE: To evaluate the cost-effectiveness of a soluble beta-glucan-containing gel as short-term adjunct therapy in the treatment of hard-to-heal wounds in a UK community health-care setting. METHODS: A comparative clinical evaluation involving consecutive patients treated for up to eight weeks with a beta-glucan-containing gel as adjunct to standard care. This was compared with consecutive patients as retrospective controls, and using the same standard care protocol from a year previously. The inclusion criteria was wounds that were slow-healing or stalled (<40% healing in four weeks). RESULTS: A total of 300 patients took part. Complete follow-up at 24 weeks was available for 144 patients in the beta-glucan group, and 136 patients in the standard care group. At 24 weeks, the beta-glucan group had a 96% healing rate compared with 75% in the standard care group (p<0.001). The improvement in healing was associated with a reduction in the mean number of weeks of treatment per patient (7.2 and 10.7 for beta-glucan and standard care, respectively), and a reduction in the mean cost of treatment (£576 versus £685 for beta-glucan and standard care, respectively). Treatment costs included nursing time, prescription medications and dressings. In a subset of ulcer wounds (50% of the full sample), at 24 weeks the beta-glucan group had a 92% healing rate compared with 46% in the standard care group (p<0.001). Mean weeks of treatment were 10.4 versus 17.6, leading to a reduction in treatment cost of £388 per patient (£1227 versus £839) over 24 weeks. CONCLUSION: The results of this evaluation suggest that short-term use of the beta-glucan gel as an adjunct to standard care on slow-healing wounds can shorten healing times and reduce NHS costs.

Extraction and Isolation of ß-Glucan from Grain Sources-A Review.

A collective report on the extraction and isolation of ß-glucan from grain sources, namely, oat, barley, and wheat is presented. An analysis on the effect of medium, pH, and temperature on the purity and yield of the ß-glucan derived under acidic/alkaline/aqueous/enzymatic conditions is also made. Water extraction and alkali extraction processes are preferred as the yield and recovery of extracted ß-glucan were good. Cost-effective development of the process for deriving high molecular weight ß-glucan is the current requirement for its wide applications in food and pharmaceutical industries.

The cost-effectiveness of a novel soluble beta-glucan gel.

OBJECTIVE: Wounds that have stalled healing are costly in terms of patient morbidity and increase in use of material and financial resources. A natural polymer beta-glucans has been incorporated into a methylcellulose gel to provide a topical gel designed to accelerate healing in wounds where it has stalled. Although the gel provides an environment conducive to moist wound healing the active agent, beta-glucans, activate the innate immune response. METHOD: Using a Markov cohort simulation model, data were extrapolated from a double-blind randomised trial to evaluate the economic benefits of the soluble beta-glucan (SBG) gel in the treatment of diabetic foot ulcers (DFUs). RESULTS: Over an annual budget cycle, SBG gel is expected to heal 94% of wounds compared with 78% when given standard care. It also healed wounds more quickly, with the average expected healed weeks 34.4 in the SBG gel group, compared with 24.7 methylcellulose dressing group. In our model this leads to a cost saving over an annual budget cycle of £503 per patient. Note: healed weeks refers to the number of weeks when the wound has healed during the 12-week period and should not be confused with weeks to healing. CONCLUSION: The shorter healing time associated with the SBG gel treatment leads to a cost saving because fewer weeks of treatment are required to heal the wound, suggesting this is a promising new cost-effective option for the treatment of DFUs.

Cost-effectiveness of Maintaining Daily Intake of Oat ß-Glucan for Coronary Heart Disease Primary Prevention.

PURPOSE: Oat ß-glucan reduces cholesterol levels and thus reduces the risk for coronary heart disease (CHD). However, its economic impact has not been well studied. We examined the economic impact of daily intake of ≥3 g of oat ß-glucan in primary prevention of CHD in patients receiving statins or no pharmacologic treatment. METHODS: A decision model was developed to compare costs and outcomes associated with lowering cholesterol levels with no pharmacologic treatment and normal diet, no pharmacologic treatment plus ≥3 g/d of oat ß-glucan, and statin therapy plus ≥3 g/d of oat ß-glucan. The population comprised men 45, 55, or 65 years of age with no history of cardiovascular disease and a 10-year risk for CHD of 5%, 7.5%, or 10%. Clinical efficacy data were gathered from meta-analyses; safety data, costs, and utilities were gathered from published literature. Cost per quality-adjusted life years and number of first events were reported. FINDINGS: Maintaining ≥3 g/d of ß-glucan may be cost-effective in men aged 45, 55, and 65 years with 10-year CHD risks of 5.0%, 7.5%, and 10.0% taking no pharmacologic treatment or on statins. It may also reduce first events of myocardial infarction and CHD death. Results are sensitive to oat ß-glucan cost but insensitive to changes in other parameters. Maintaining ≥3 g of oat ß-glucan daily remains cost-effective within plausible range of values. IMPLICATIONS: ß-glucan may be cost-effective for preventing CHD events in middle-aged men with no history of cardiovascular events whose 10-year CHD risk is ≥5%. Maintaining daily ß-glucan intake may have considerable impact on first events.

New developments and prospective applications for beta (1,3) glucans.

Publications and patents relative to newly observed functions of beta-(1,3)-D-glucans have notably increased in the last few years with the exploitation of their biological activities. The term beta-(1,3)-D-glucans includes a very large number of polysaccharides from bacterial, fungal and vegetable sources. Their structures have a common backbone of beta-(1,3) linked glucopyranosyl residues but the polysaccharidic chain can be beta-(1,6) branched with glucose or integrate some beta-(1,4) linked glucopyranosyl residues in the main chain. Except for the curdlan, a bacterial linear beta-(1,3)-D-glucans, and for the scleroglucan produced by Sclerotium rolfsii, the main drawback limiting the development of these polysaccharides is the lack of efficient processes for their extraction and purification and their cost. However new applications in agronomy, foods, cosmetic and therapeutic could in a next future accentuate the effort of research for their development. So this review focuses on these beta-(1,3)-D-glucans with the objective to detail the strategies employed for their extraction and the relation structure-functions identified when they induce biological activities.