Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- DoubleGood AB
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Postprandial glucose response
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Drink intervention
Placebo and two drinks containing a blend of five amino acids and chromium picolinate, are included with every main meal and served in a standardized, non-randomised order.
Intervention: Drinks containing 5AA+CrPic and Placebo (Dietary Supplement)
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)