E11
Conditions
Interventions
Group 1: Administration of typical dose of D-allulose and observation of blood sugar values.
Group 2: Administration of typical dose of D-allulose and observation of blood sugar values in diabetes.
Sponsors
Savanna Ingredients GmbH
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy volunteers • male/female (50:50) • Age: 20-75 years • BMI: 18-25 kg/m2 • Written informed consent Inclusion criteria for individuals with type 2 diabetes • Male/female (50:50) • Age: 20-75 years • BMI: 18.5-40 kg/m2 • Established diabetes • Dietetic treatment • Medication: only metformin or DPP IV inhibitors and insulin • Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy volunteers •Missing written informed consent •Current participation in other intervention studies •Metabolic diseases including type 2 diabetes •Untreated hypertension (RR > 160/95 mmHg) •Cardiovascular diseases, e.g. coronary heart disease •Gastrointestinal diseases •Known fructose intolerance •Cancer diagnosis within the last 5 years •Chronic renal diseases •Acute infections, e.g. urinary tract infection, COVID-19 •Pregnant and lactating women •Any psychiatric disorder Exclusion criteria for individuals with type 2 diabetes •Missing written informed consent •HbA1c > 10.0% ( >85.8 mmol/mol), •Glomerular filtration rate: 160/95 mmHg) •Cardiovascular diseases, e.g. coronary heart disease • Acute gastrointestinal diseases (e.g. cholecystitis, gastroenteritis) •Known fructose intolerance •Cancer diagnosis within the last 5 years •Chronic renal diseases •Acute infections, e.g. urinary tract infection, Covid-19 •Pregnant and lactating women •Any psychiatric disorder (except depression)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -post intervention levels of D-allulose and glucose as absolute levels and with AUC in blood (-10, 0, 15, 30, 60, 120, 180, 480 min, 24h, 48h) -cumulative allulose excretion in 24h- and 48h urine | — |
Secondary
| Measure | Time frame |
|---|---|
| • subjective tolerability assessed by visual analogue scales on composite digestive parameters • 3-Deoxy glucosulose • amino acid in free and peptide-bound form • gastrointestinal hormones | — |
Countries
Germany
Contacts
Public ContactThomas Skurk
Technischen Universität München ZIEL-Institute for Food and Health Core Facility für Humanstudien
Outcome results
None listed