Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glycemic Control
- Sponsor
- DoubleGood AB
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Postprandial glucose response
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 25-29.9 kg/m\^2
- •HOMA-IR \< 2.5
- •Fasting glucose \< 6.1 mmol/L
- •Stable weight since 3 months
- •Access to iPhone with Bluetooth 4.0 and iOS 13 or later
Exclusion Criteria
- •Pharmacological treatment known to interfer with metabolism
- •Antibiotics treatment the latest 3 months
- •Vegetarian/Vegan diet
- •Use of tobacco
- •Pregnancy or breast-feeding
Outcomes
Primary Outcomes
Postprandial glucose response
Time Frame: From start of meal (0 min) to 120 min postprandially
Incremental area under the blood glucose curve after each meal
Secondary Outcomes
- Glycemic variability(24 hour cycles)