The Effect of a Multi-strain Probiotic on Metabolic Biomarkers in Adults with Pre-diabetes and Recently Diagnosed with Type 2 Diabetes

Phase 1

Completed

• Conditions: Obesity; Insulin resistance; Type 2 Diabetes; Metabolic and Endocrine - Metabolic disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine; Diet and Nutrition - Obesity

• Registration Number: ACTRN12613001378718
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-16
• Study Completion: 2016-10-19
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified