Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans

Glycemic Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848233
• Other study ID #: DG2101_CGM
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: May 26, 2021

Study information

• Verified date: November 2022
• Source: DoubleGood AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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:

• Diabetes

• Pharmacological treatment known to interfer with metabolism

• Antibiotics treatment the latest 3 months

• Vegetarian/Vegan diet

• Use of tobacco

• Pregnancy or breast-feeding

Related Conditions & MeSH terms

• Diet, Food and Nutrition
• Glycemic Control

Intervention

Dietary Supplement:
• Drinks containing 5AA+CrPic and Placebo
Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.

Locations

Country	Name	City	State
Sweden	Aventure AB	Lund

Sponsors (2)

Lead Sponsor	Collaborator
DoubleGood AB	starScience GmbH

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Samigullin A, Humpert PM, Östman E. Continuous glucose monitoring as a close to real life alternative to meal studies - a pilot study with a functional drink containing amino acids and chromium. Front Med Technol. 2022 Aug 18;4:931837. doi: 10.3389/fmedt. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose response	Incremental area under the blood glucose curve after each meal	From start of meal (0 min) to 120 min postprandially
Secondary	Glycemic variability	Variation in blood glucose levels	24 hour cycles