None listed
Conditions
Brief summary
The aim of this study is to assess the efficacy of a probiotic preparation in improving glucose metabolism and metabolic markers in adults with pre-diabetes and recently diagnosed with T2DM. Moreover, gut permeability, faecal and metabolomic profiles will be measured to evaluate a potential mechanisms of action of the multi-strain probiotic. We hypothesize that the administration of an evidence based probiotic preparation may modulate the GI microbiota from a dysbiotic to a balanced state improving blood glucose levels, decreasing inflammatory markers and endotoxaemia, and improving lipid profiles.
Interventions
Participants will be randomised to take either a multi-strain probiotic preparation or a placebo for 12 weeks duration and will be provided with supplementation every 6 weeks.
The product contains 8 probiotic strains (3 Lactobacillus, 3 Bifidobacterium, Streptococcus thermophilus and 1 yeast (500 mg per capsule equating to 50 billion cfu). Two capsules of the probiotic/placebo will be prescribed to be taken twice a day. The probiotic has to be consumed orally with cold non-carbonated water. The
Participants will be randomised to take either a multi-strain probiotic preparation or a placebo for 12 weeks duration and will be provided with supplementation every 6 weeks. The product contains 8 probiotic strains (3 Lactobacillus, 3 Bifidobacterium, Streptococcus thermophilus and 1 yeast (500 mg per capsule equating to 50 billion cfu). Two capsules of the probiotic/placebo will be prescribed to be taken twice a day. The probiotic has to be consumed orally with cold non-carbonated water. The product should not be taken with hot and carbonated drinks. Participants must return the remaining study supplement and a diary provided to record trial supplement intake every 6 weeks.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Overweight adults (BMI greater than or equal to 25 kg/m2) with pre-diabetes (impaired fasting glucose, IFG and/or impaired glucose tolerance, IGT) or recently diagnosed with T2DM (less than 12 months) - Treated by diet alone or diet plus metformin
Exclusion criteria
- Subjects with type 1 diabetes. - Taking oral blood glucose-lowering medications or anti-obesity drugs (other than metformin) Pregnant, breast feeding or planning on becoming pregnant - Concomitant GI disorders. - Taking antibiotics and dietary supplements including fish oil, probiotics, prebiotics, multivitamins, minerals, herbal preparations etc. 4 weeks before commencing the trial and for the duration of the trial. - Alcohol abuse and the use of any illicit drug - Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant
Outcome results
None listed