Efficacy of probiotics and/or intermittent fasting to improve prediabetes
- Conditions
- prediabetestype 2 diabetesDiet and Nutrition - ObesityMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12616001050448
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 560
Prediabetes defined by HbA1c 41-49 mmol/mol inclusive
BMI of 30-40 (or 27-40 if Asian Indian ethnicity)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline[3 months and 1 year]
- Secondary Outcome Measures
Name Time Method