Individuals with HbA1c levels between 39.0 mmol/mol and 51.9 mmol/mol (5.7% to 6.9%) Nutritional, Metabolic, Endocrine
Conditions
Interventions
Eligible participants will be randomised into one of three arms as below taken by mouth once daily for 6 weeks, followed by a 2-week washout period:
Arm 1: Placebo (microcrystalline cellulose)
Arm 2:
Sponsors
Danisco Sweeteners Oy, a wholly owned subsidiary of International Flavors & Fragrances Inc. (IFF)
Eligibility
Sex/Gender
All
Age
25 Years to 50 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 04/02/2026: 1. Pre-menopausal female aged 25-45 years old, or male aged 25-50 years old 2. Evidence of HbA1c value between 39.0 mmol/mol and 51.9mmol/mol (5.7% to 6.9%) within the past 12 months 3. Weight stable over the last 12 months (±5%) 4. Current BMI between 20-45 kg/m2 5. Have access to a smartphone, tablet or laptop/computer 6. Able and willing to give consent to the trial prior to participation. 7. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 8. Able and willing to use a continuous glucose monitor (CGM) device for up to six weeks. 9. Willing to maintain their usual lifestyle throughout the trial, i.e., agrees not to change their dietary habits and level of exercise etc. during the trial and does not currently utilise an extreme diet or exercise plan. 10. Willing to allow their General Practitioner, if appropriate, to be notified of participation in the trial. 11. Females of child-bearing potential must agree to use medically approved methods for birth control including condoms with or without spermicides, hormonal contraceptives (oestrogen and/or progestin products; either oral, intrauterine, or epidermal) or intrauterine device with copper. The contraceptive method should have been in place for at least 3 cycles before the beginning of the trial and should not be modified during the trial. Previous key inclusion criteria as of 04/09/2025: 1. Pre-menopausal female aged 25-45 years old, or male aged 25-50 years old 2. Evidence of HbA1c value between 42.1 mmol/mol and 51.9mmol/mol (6.0% to 6.9%) within the past 12 months 3. Weight stable over the last 12 months (±5%) 4. Current BMI between 20-45 kg/m2 5. Have access to a smartphone, tablet or laptop/computer 6. Able and willing to give consent to the trial prior to participation. 7. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 8. Able and willing to use a continuous glucose monitor (CGM) device for up to six weeks. 9. Willing to maintain their usual lifestyle throughout the trial, i.e., agrees not to change their dietary habits and level of exercise etc. during the trial and does not currently utilise an extreme diet or exercise plan. 10. Willing to allow their General Practitioner, if appropriate, to be notified of participation in the trial. 11. Females of child-bearing potential must agree to use medically approved methods for birth control including condoms with or without spermicides, hormonal contraceptives (oestrogen and/or progestin products; either oral, intrauterine, or epidermal) or intrauterine device with copper. The contraceptive method should have been in place for at least 3 cycles before the beginning of the trial and should not be modified during the trial. Previous key inclusion criteria: 1. Pre-menopausal female aged 25-45 years old, or male aged 25-50 years old 2. Evidence of HbA1c value between 42.1 mmol/mol and 51.9mmol/mol (6.0% to 6.9%) within the past 6 months 3. Weight stable over the last 6 months (±5%) 4. Current BMI between 20-45 kg/m2 5. Have access to a smartphone, tablet or laptop/computer 6. Able and willing to give consent to the trial prior to participation. 7. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 8. Able and willing to use a continuous glucose monitor (CGM) device for up to six weeks. 9. Willing to maintain their usual lifestyle throughout the trial, i.e., agrees
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 04/02/2026: 1. Participants with self-reported current or prior diagnosis of: 1.1. Hypersensitivity, allergy or intolerance to any ingredient in the investigational products 1.2. 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 enrolment 1.4. Gastrointestinal surgery (except for appendicitis or hernia surgery) 1.5. Type 1 diabetes 1.6. Pituitary dysfunction 1.7. Significant psychiatric disorder, including any eating disorder 1.8. Severe hepatic (liver) disease including severe derangement of LFTs as defined by any of the below: 1.8.1 ALT > 3x ULN 1.8.2 AST > 3x ULN 1.8.3 Bilirubin > 3x ULN 1.8.4 Albumin 160/100) 1.12. Significant dyslipidaemia (>3 months use of low-dose statins permitted*) as defined by any of the below: 1.12.1 Triglycerides >5.6 mmol/L (>500 mg/dL) 1.12.2 LDL cholesterol >5.0 mmol/L (>190 mg/dL) (67% above normal) 1.12.3 Total cholesterol >8.0 mmol/L (>310 mg/dL) (54% above normal) 1.12.4 HDL cholesterol 30 × 10?/L (170% above normal) 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 data 4. Currently taking diabetes-specific medication 5. 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 entry 8. Steroid use (except for topical steroids and inhalers) 9. Paracetamol use during the period of trial participation 10. Currently taking Hydroxyurea 11. Current or recent (within 3 weeks prior to enrolment) 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 participation 14. Current participation in a weight loss program or planned during the planned period of trial participation 15. Participation in another interventional clinical trial in the last 30 days. 16. Longer-term absence planned during the planned period of trial participation 17. Any other significant dise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose percentage time in range measured via continuous glucose monitor (CGM) during the baseline 14-day period and week 5-6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/10/2025: 1. Glucose variability measured via CGM during the baseline 14-day period and week 7 and 8 2. Serum cholesterol triglycerides (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) measured using a blood test at baseline, week 6 and week 8 3. Glycaemic variability percentage measured via CGM during the baseline 14-day period and week 5-6 and week 7-8 4. Frequency of hypoglycaemia measured via CGM during the baseline 14-day period and week 5-6 and week 7-8 5. Frequency of hyperglycaemia measured via CGM during the baseline 14-day period and week 5-6 and week 7-8 6. HbA1c measured using a blood test at baseline and week 6 7. Fasting insulin and glucose levels measured using a blood test at baseline, week 6 and week 8 8. Gut proteins (GLP-1, GIP, PYY, ghrelin, and leptin) measured using a blood test at baseline, week 6 and week 8 9. Estimated glomerular filtration rate (eGFR) measured using a blood test at baseline, week 6 and week 8 10. Sleep quality measured via the Pittsburgh Sleep Quality Index (PSQI) at baseline, week 6 and week 8 11. Quality of life measured via the EQ-5D-5L at baseline, week 6 and week 8 12. Insulin sensitivity measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) measured at baseline, week 6 and week 8 13. Insulin resistance measured using the Triglycerides-Glucose Index (TyG) measured at baseline, week 6 and week 8 14. hs-CRP measured using blood test at baseline, week 6 and week 8 _____ Previous secondary outcome measures: 1. Serum cholesterol triglycerides (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) measured using a blood test at baseline, week 6 and week 8 2. Glycaemic variability percentage measured via CGM during the baseline 14-day period and week 5-6 3. Frequency of hypoglycaemia measured via CGM during the baseline 14-day period and week 5-6 4. HbA1c measured using a blood test at baseline and week 6 5. Fasting ins | — |
Countries
England, United Kingdom
Contacts
Public ContactBeth Hawkins
Outcome results
None listed