Clinical study to evaluate the effect of a low-glycemic carbohydrate on GLP-1 release in healthy volunteers: randomized, single-blind, placebo-controlled, cross-over study with different doses
- Conditions
- Investigation of the effects of carbohydrates on hormonal responses in healthy adults.
- Registration Number
- DRKS00034639
- Lead Sponsor
- Beneo GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 16
Subject is in good physical and mental health as established by medical history and physical examination
Age: 18-50 years
BMI =18.5 and =30.0 kg/m²
No medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable
Nonsmoker
No changes in food habits or physical activity 6 months prior to screening and during the study
Written informed consent to participate in the study
Able and willing to follow the study protocol procedures.
A known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions
A major medical or surgical event requiring hospitalization within the preceding 5 months
Known fructose intolerance or malabsorption
The presence of disease or drug(s) which influence digestion and absorption of nutrients
The use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of the active GLP-1 concentration in the blood:<br>GLP-1 (glucagon-like peptide 1) is measured in the plasma samples at the time points pre, 15, 30 45, 60, 90 and 120 min post. The pharmacokinetic characteristics are determined from the concentration-time curves (incremental area under the curve, iAUC).
- Secondary Outcome Measures
Name Time Method Measurement of the total GLP-1 concentration in the blood:<br>GLP-1 is measured in the plasma samples at the time points pre, 15, 30 45, 60, 90 and 120 min post. The pharmacokinetic characteristics are determined from the concentration-time curves (incremental area under the curve, iAUC).<br><br>Measurement of the blood glucose concentration in the blood:<br>Blood glucose is measured in plasma samples at the time points pre, 15, 30 45, 60, 90 and 120 min post. The pharmacokinetic characteristics are determined from the concentration-time curves (incremental area under the curve, iAUC).<br><br>Measurement of the insulin concentration in the blood:<br>Insulin is measured in the plasma samples at the time points pre and 120 min post. The insulin sensitivity index is determined from the values.