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

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

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 Overview

• Status: Completed
• Conditions: Glycemic Control; Diet, Food and Nutrition
• Intervention / Treatment: Dietary supplement: Drinks containing 5AA+CrPic and Placebo

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 223 63
    • Aventure AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glucose response	Incremental area under the blood glucose curve after each meal	From start of meal (0 min) to 120 min postprandially

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variability	Variation in blood glucose levels	24 hour cycles

Collaborators and Investigators

• Sponsor: DoubleGood AB
• Collaborators: starScience GmbH
• Investigators: Principal Investigator: Elin Ostman, PhD, Aventure AB

Publications and helpful links

General Publications

• Samigullin A, Humpert PM, Ostman 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.2022.931837. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DG2101_CGM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No