E11
Conditions
Interventions
Group 1: over 6 weeks daily oral dose of 700 mg prebiotics oral with the breakfast
Group 2: over 6 weeks daily oral dose of 700 mg rice flour oral with the breakfast
Sponsors
Sugarburner AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.age > 18 years 2. diagnosed type 2 diabetes mellitus 3. HbA1c value within the last 2 months before screening visit > 6.0% and < 9.9% 4. receiving one or a combination of the following antidiabetic treatments: • lifestyle only (diet and exercise) • oral antidiabetic treatment • GLP1-analogs • insulin treatment
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus type 1 2. Acute or chronic gastrointestinal disease 3. Anemia 4. Acute hyperthyreosis (TSH value not within normal range) 5. History of severe or multiple allergies 6. Known allergy against probiotic nutritional supplements 7. Participation in a clinical trial within 3 months before trial entry. 8. Progressive fatal diseases 9. Drug or alcohol abuse within the last 5 years 10. Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is the evaluation of the impact of SugarBurner on glycemic control (time in normoglycemia) as compared to placebo and as assessed by continuous glucose measurement by means of the Freestyle Libre 2 device after 2, 4, and 6 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of the dietary supplement in comparison to placebo on: • HbA1c • Lipids • Uric acid • Insulin Sensitivity as assessed by HOMA Score • ß-cell function as assessed by fasting intact proinsulin values • cardiovascular risk / inflammatory status as assessed by hsCRP • tolerability of the supplement (type and number of adverse events) | — |
Countries
Germany
Outcome results
None listed