The fate, kinetics and metabolic effects of allulose
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00028577
- Lead Sponsor
- Savanna Ingredients GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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 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: <45ml/min (G3a)
•Current participation in other intervention studies
•Untreated hypertension (RR > 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -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)<br>-cumulative allulose excretion in 24h- and 48h urine
- Secondary Outcome Measures
Name Time Method • subjective tolerability assessed by visual analogue scales on composite digestive parameters<br>• 3-Deoxy glucosulose<br>• amino acid in free and peptide-bound form<br>• gastrointestinal hormones