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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04848233
Enrollment
6
Registered
2021-04-19
Start date
2021-04-20
Completion date
2021-05-26
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Food and Nutrition, Glycemic Control

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.

Interventions

DIETARY_SUPPLEMENTDrinks 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.

Sponsors

starScience GmbH
CollaboratorUNKNOWN
DoubleGood AB
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
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

* Diabetes * Pharmacological treatment known to interfer with metabolism * Antibiotics treatment the latest 3 months * Vegetarian/Vegan diet * Use of tobacco * Pregnancy or breast-feeding

Design outcomes

Primary

MeasureTime frameDescription
Postprandial glucose responseFrom start of meal (0 min) to 120 min postprandiallyIncremental area under the blood glucose curve after each meal

Secondary

MeasureTime frameDescription
Glycemic variability24 hour cyclesVariation in blood glucose levels

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026