We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Molly
Bush
+44 (0)800 0584496
molly@lindushealth.com
Dr
John Luke
Twelves
+44 (0)800 0584496
luke@lindushealth.com
Individuals with HbA1c levels between 42.1 mmol/mol and 51.9 mmol/mol (6.0% to 6.9%)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
This study is investigating whether a probiotic strain called Levilactobacillus brevis can help improve blood glucose levels and metabolic health. This study aims to determine if this dietary supplement might help regulate blood sugar levels by comparing the effects of high-dose probiotic, low-dose probiotic, and placebo on glucose variability in people with slightly elevated blood sugar levels.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Participants with self-reported current or prior diagnosis of:1.1. Hypersensitivity, allergy or intolerance to any ingredient in the investigational products1.2. Gastrointestinal conditions including lactose intolerance, coeliac disease, gastroesophageal reflux disease, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD)1.3. Recent gastrointestinal infection within 4 weeks prior to enrolment1.4. Gastrointestinal surgery (except for appendicitis or hernia surgery)1.5. Type 1 diabetes1.6. Pituitary dysfunction1.7. Significant psychiatric disorder, including any eating disorder1.8. Severe hepatic (liver) disease1.9. Severe organic diseases, including cancer, coronary heart disease, heart failure, myocardial infarction, autoimmune disease, kidney disease, cerebral apoplexy or terminal illness1.10. Infectious diseases, including pulmonary tuberculosis and AIDS1.11. Severe hypertension (>160/100)1.12. Significant dyslipidaemia (>3 months use of low-dose statins permitted*)2. Any self-declared clinically significant alcohol misuse (more than 14 units of alcohol per week) at screening that may impact the safety of the participant or the trial data.3. Any self-declared use of illicit drugs at screening that may impact the safety of the participant or the trial data4. Currently taking diabetes-specific medication5. Antibiotic course of any duration within 3 months before screening or any active infection during the screening period or ongoing chronic infection for the duration of the trial.6. Receiving drug therapy to treat cholecystitis, peptic ulcers, urinary tract infection, acute pyelonephritis, or urocystitis 7. Continuous use of weight-loss drug within 3 months of trial entry8. Steroid use (except for topical steroids and inhalers)9. Paracetamol use during the period of trial participation10. Currently taking Hydroxyurea11. Current or recent (within 3 weeks prior to screening) use of any dietary supplements, such as probiotics, prebiotics, synbiotics, vitamins (except vitamin D), fermented milk, and/or yogurt containing probiotics, omega-3 fatty acids, plant stanols/sterols), including the use of food supplements for blood glucose control (e.g. chromium picolinate)12. Current consumption of vitamin D supplement exceeding 10 µg per day 13. Pregnant or breastfeeding, or planning to become pregnant during the planned period of trial participation14. Current participation in a weight loss program or planned during the planned period of trial participation15. Participation in another interventional clinical trial in the last 30 days.16. Longer-term absence planned during the planned period of trial participation17. Any other significant disease or disorder which, in the opinion of the Investigator, may put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
*NICE Guidelines will be used to define low doses of statins.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
John Luke
Twelves
+44 (0)800 0584496
luke@lindushealth.com
Miss
Molly
Bush
+44 (0)800 0584496
molly@lindushealth.com
The study is sponsored by Danisco Sweeteners Oy, a wholly owned subsidiary of International Flavors & Fragrances Inc. (IFF) and funded by Danisco Sweeteners Oy, a wholly owned subsidiary of International Flavors & Fragrances Inc, (IFF).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
