Not available
ACTRN12613001378718
Treatment
Phase 1
Commercial sector/Industry,Medlab Clinical Ltd
Prof Luis Vitetta
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 improv .... Read more
- 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
- 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 b .... Read more
No
Sample Size 60
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Insulin resistance , Obesity , Type 2 Diabetes
Condition code Alternative and Complementary Medicine , Diet and Nutrition , Metabolic and Endocrine
Intervention code Treatment: Other
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 .... Read more
Control group Placebo
The control group will take a placebo which contains inactive ingredients that will look, smell and taste like the probiotic but without any medical benefit. Participants randomised to the control group will take 2 capsules of the placebo preparation (200 mg of microcrytalline cellulose and excipients) twice a day for 12 weeks.
Outcome: Fasting plasma glucose Timepoint: Baseline and 12 weeks after intervention commencement
yes
IPD underlying published results only
From 1st July 2023 data will be available for an indefinite time
Researchers from not-for-profit organisations. All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any approved protocol/proposal