None listed
Conditions
Brief summary
Preventing the progression from prediabetes to Type 2 Diabetes (T2D) is a health priority for New Zealand. We wish to test the effectiveness of two promising, simple interventions on reducing progression of prediabetes: a daily probiotic supplement and intermittent fasting. Lactobacillus rhamnosus HN001 probiotic (6x109 cfu dose) has been shown to reduce the incidence of gestational diabetes, so may also prevent progression of prediabetes. The benefits of daily caloric restriction on reducing the risk of T2D are well-known, but this strategy is difficult to sustain. There is some evidence that the benefits of intermittent fasting may be similar, but with greater adherence and acceptability than continuous caloric restriction. Given both of these approaches target the gut microbiota, there is a possibility of synergistic effects through altered pancreatic and liver fat deposition. The aim of the overall project is to determine whether daily supplementation with a capsule containing L. rhamnosus HN001 or intermittent 5:2 fasting or the combination will reduce progression of prediabetes. We are proposing a one-year, clinical trial among 560 people with prediabetes who will be randomised to either (1) intermittent fasting (reducing calories to 600kcal/day for women and 650kcal/day for men, on 2 days of every week) + daily probiotic capsule (2) intermittent fasting + daily placebo (3) daily healthy eating efforts + daily probiotic (4) daily healthy eating efforts + daily placebo (control). The primary outcome of this study is HbA1c at 1 year. Key secondary outcomes include change in body weight, body composition (fat partitioning), fasting glucose and fats.
Interventions
1. Daily probiotic capsule (containing Lactobacillus rhamnosus HN001, at a dose of 6x10^9cfu) for 1 year plus usual healthy diet (according to standard dietary guidelines) for 1 year
2. Daily probiotic capsule (containing Lactobacillus rhamnosus HN001, at a dose of 6x10^9cfu) for 1 year plus intermittent fasting (2 out of 7 days) when 600kcal/day is consumed by women and 650kcal/day is consumed by men, for 1 year
3. Daily placebo capsule (containing corn-derived maltodextrin with identical appea
1. Daily probiotic capsule (containing Lactobacillus rhamnosus HN001, at a dose of 6x10^9cfu) for 1 year plus usual healthy diet (according to standard dietary guidelines) for 1 year 2. Daily probiotic capsule (containing Lactobacillus rhamnosus HN001, at a dose of 6x10^9cfu) for 1 year plus intermittent fasting (2 out of 7 days) when 600kcal/day is consumed by women and 650kcal/day is consumed by men, for 1 year 3. Daily placebo capsule (containing corn-derived maltodextrin with identical appearance and similar smell to the probiotic capsule) for 1 year plus intermittent fasting (2 out of 7 days) when 600kcal/day is consumed by women and 650kcal/day is consumed by men, for 1 year 4. Placebo capsule (containing corn-derived maltodextrin with identical appearance and similar smell to the probiotic capsule) for 1 year plus usual healthy diet (according to standard dietary guidelines) for 1 year Strategies to monitor adherence with daily capsules will be empty capsule packet return and self-reported adherence. Strategies to monitor adherence with diet will be food diary and reported adherence Guidance on intermittent fasting will include 4 x 1 hour duration group/individual sessions with a dietitian for tailored IF advice (at baseline, 2, 4 and 8 weeks), and resource list with written material, choice of apps, books and invited, closed social networking site for intermittent fasting study group members moderated by a dietitian. Participants will self-select individual or group sessions. The intermittent fasting days will be selected by the participants as either consecutive or non-consecutive days. No specific instruction for the 5 non-fasting days will be given other than usual healthy diet pamphlet and recommendations regarding physical activity will be provided to both dietary groups. Guidance on usual health diet will include only a usual health diet pamphlet. No specific contact with a dietitian or additional resources will be provided.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Prediabetes defined by HbA1c 41-49 mmol/mol inclusive BMI of 30-40 (or 27-40 if Asian Indian ethnicity)
Exclusion criteria
Previous bariatric surgery, BMI >40kg/m2, on glucose lowering medications, conditions that might influence body weight regulation (eg: malabsorption, thyroid disorders, eating disorders, use of systemic steroids, excess alcohol intake (>21 units per week in men, >14 units per week in women), stable body weight in previous 6 months, planned major changes in physical activity during the study to an extent that might interfere with the study outcome, blood donation withthin past 2 months prior to the study (and at the endpoints), adults with a weight change of >3kg within 3 months prior to first baseline visit, psychiatric disease, pregnant women or lactating, or intending to become pregnant within the study duration, significant renal disease (GFR<30), congestive heart failure, unexplained syncope, recent myocardial infarction or stroke within 6 months, porphyria, thalassemia (or other blood disorders in which HbA1c is inaccurate for glycemia), splenectomy, participation in other clinical studies within the previous 6 months, not accepting of 5:2 intermittent fasting or probiotic supplementation. For the MRI studies, those with any implanted metal or electornic devices will not be able to take part.
Outcome results
None listed