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Clinical Trials/NCT04848233
NCT04848233
Completed
Not Applicable

Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial

DoubleGood AB1 site in 1 country6 target enrollmentApril 20, 2021

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2021
End Date
May 26, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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