Prediabetes, increased risk to develop diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Subjects were stratified to sex and fasting blood glucose group (between 5.6 and 6.9 mmol/L or between 5.0 and 5.6 mmol/L) and within these strata subjects were randomly assigned to arm A or B. Random
Sponsors
Wageningen University (WU) Division of Human Nutrition (Bode 62)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 40-75 years 2. Fasting blood glucose between 5.6 and 6.9 mmol/L (pre-diabetes according to American Diabetes Association 2016), or fasting blood glucose between 5.0 and 5.6 mmol/L and diabetes risk score (DRS) = 9
Exclusion criteria
Exclusion criteria: 1. Having a history of medical or surgical events that may significantly affect the study outcome: IBS or IBD patients 2. Medical drug use: for diabetes 3. Medical drug use: antibiotic use within 3 months of the study screenings day or chronic use of antacids 4. Mental status that is incompatible with the proper conduct of the study 5. Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening 6. Reported slimming or medically prescribed diet 7. Reported vegan or macrobiotic lifestyle 8. Consumption of pre-probiotics or fibre supplements as of 1 month before the screening 9. Sensitive to medical skin adhesives 10. Not willing or afraid to give a blood donation during the study 11. Personnel of Wageningen University, Department of Human Nutrition, their partner and their first-degree relatives 12. Current participation in other research from the Division of Human Nutrition 13. Not having a general practitioner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting insulin measured in EDTA plasma using ELISA, and HOMA-ir calculated using software from Matthews et al. (1985) (https://www.dtu.ox.ac.uk/homacalculator), at baseline and at end of intervention period, i.e. after 5 weeks (2 weeks run-in and 3 weeks intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean glucose and glycaemic variability measured using continuous glucose monitoring (FreeStyle Libre) for 14 days during baseline and run-in and again 14 days during the intervention (first two weeks of three weeks intervention) 2. Fasting GLP-1/PYY level in aprotinin plasma with DPP4-inhibitor measured using ELISA at baseline and at end of the intervention period, i.e. after 5 weeks (2 weeks run-in and 3 weeks intervention) 3. Fasting breath hydrogen measured using Quintron Microanalyzer at baseline and at end of the intervention period, i.e. after 5 weeks (2 weeks run-in and 3 weeks intervention) 4. Body weight measured using a digital weighing scale to the nearest 0.1 kg, and waist circumference measured using a measuring tape to the nearest 0.5 cm, at baseline, at the end of the run-in (after 2 weeks) and at the end of the intervention (after 5 weeks from baseline) 5. Microbiota composition measured using DNA extraction and 16s RNA gene sequencing at baseline, at the end of the run-in (after 2 weeks) and at the end of the intervention (after 5 weeks from baseline) and after a wash-out period (7 weeks after baseline) 6. SCFA measured in faeces using HPLC at baseline, at the end of the run-in (after 2 weeks) and at the end of the intervention (after 5 weeks from baseline) and after a wash-out period (7 weeks after baseline) | — |
Countries
Netherlands
Contacts
Public ContactMarie-Luise Puhlmann
Outcome results
None listed