increased blood glucose/HbA1c/oGTT-levels
Conditions
Interventions
Group 1: investigational product PDM022616
ingredients: plant extract, Mineral, trace element
3x1 capsule per day with meals for 16 weeks
prediabetic persons
Sponsors
Cefak KG
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: - BMI 25-34.9 kg/m2 - HbA1c 5.7-6.4% (39-47 mmol/mol) at V1 - Subject’s agreement to comply with study procedures - Stable concomitant medications (if any) for at least last 3 months prior to V1 and during the study - Stable body weight (=3 kg difference) for the last 3 months prior to V1 - Regular intake of three main meals (breakfast, lunch and dinner) - Women of childbearing potential: a. negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 b. commitment to use contraception methods during the study
Exclusion criteria
Exclusion criteria: 1. Known sensitivity to the components of the investigational product 2. Pathological electrocardiogram (ECG) 3. Psychotic disorders within the last 6 months prior to V1 4. History and/or presence of clinically significant disease, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: a. eating disorders such as anorexia b. untreated or non-stabilized thyroid disorder c. untreated or non-stabilized hypertension d. significant gastrointestinal diseases e. spleen disorder f. known severe acute or chronic immunological disorders such as AIDS (or HIV positive) g. severe acute or chronic infection h. any other known significant or serious condition/disease that renders subjects ineligible (e.g. history of malignancy within the past 5 years prior to V1, any clinically significant cardiovascular, renal, liver, lung disease etc.) 5. Clinical symptoms of diabetes type 2 6. Suspected diabetes type 1 7. Known congenital disorders of glycosylation 8. Known polycystic ovarian syndrome (female subjects) 9. Use of drugs/supplements which could interfere with the results of the study as per investigator's judgement (e.g. anti-diabetic therapy, products for reduction of blood glucose levels, products with a possible impact on glycemic control) within the last month prior to V1 and during the study 10. Blood transfusion within the last 12 weeks before V1 11. Blood donation within the last 6 month before V1 12. Previously known hemoglobinopathy (HbS, HbC, HbD, HbH, HbF or HbE) 13. Anemia (Hb =11 g/dL) 14. Recent change in diet and lifestyle (within the last 4 weeks prior to V1) 15. Deviation of safety laboratory parameter(s) at V1 (except for Hb and HbA1c) that is: a. clinically significant or b. >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome) 16. History of or current abuse of drugs, alcohol or medication in the last 6 months prior to V1 17. Participation in another study during the last 30 days prior to V1 and during the study 18. Women of child-bearing potential: pregnant or breast-feeding 18. Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood sample: HbA1c at all visits, lab analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| blood sample: blood Glucose, oGTT, Insulin - all visits, lab Analysis; crp - begin and end, lab Analysis. Further parameter: Body weight, waist circumference, blood pressure. | — |
Countries
Germany
Contacts
Public ContactRalf Uebelhack
analyze&realize GmbH
Outcome results
None listed