Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and β-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 Māori, Pacific, and South Asian peoples. Th...
| Publicado en: | Trials Vol. 20; no. 1 |
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| Autores principales: | , , , , , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
BioMed Central
7/29/2019
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=137769482&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 137769482 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17456215 38OC jtl: Trials issn: 17456215 maglogo: N pubinfo: dt: 7/29/2019 vid: 20 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 137769482 137769482 NLM31358022 10.1186/s13063-019-3553-7 NLM31358022 137769482 ppct: 1 formats: tig: atl: Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and β-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. aug: au: Barthow, Christine Hood, Fiona McKinlay, Eileen Hilder, Jo Cleghorn, Christine Huthwaite, Mark Weatherall, Mark Parry-Strong, Amber Pullon, Sue Gray, Ben Wickens, Kristin Crane, Julian Krebs, Jeremy affil: Department of Medicine, University of Otago, PO Box 7343, Wellington South, 6242, Wellington, New Zealand sug: subj: Prediabetic State Diet Therapy beta-Glucans Administration and Dosage Probiotics Administration and Dosage Lactobacillus Physiology Aged, 80 and Over beta-Glucans Economics Health Status Male Clinical Trials Health Care Costs Time Factors Prediabetic State Blood Aged Probiotics Economics Young Adult Capsules beta-Glucans Adverse Effects Middle Age Qualitative Studies Prebiotics Adverse Effects Treatment Outcomes Prebiotics Economics Adult Probiotics Adverse Effects Female New Zealand Prediabetic State Microbiology Adolescence Cost Benefit Analysis Prebiotics Administration and Dosage Prediabetic State Economics Psychological Tests Aged, 80 & over Aged: 65+ years Middle Aged: 45-64 years Adult: 19-44 years Adolescent: 13-18 years Male Female ab: 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 Māori, 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 β-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 β-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. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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