Clincosm LogoSign in Get a demo

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

Sponsor
DoubleGood AB (Industry)
Overall Status
Completed
CT.gov ID
NCT04848233
Collaborator
starScience GmbH (Other)
6
Enrollment
1
Location
1
Arm
1.2
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Drinks containing 5AA+CrPic and Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
Actual Study Start Date :
Apr 20, 2021
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Postprandial glucose response [From start of meal (0 min) to 120 min postprandially]

    Incremental area under the blood glucose curve after each meal

Secondary Outcome Measures

  1. Glycemic variability [24 hour cycles]

    Variation in blood glucose levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
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:

  • Diabetes

  • Pharmacological treatment known to interfer with metabolism

  • Antibiotics treatment the latest 3 months

  • Vegetarian/Vegan diet

  • Use of tobacco

  • Pregnancy or breast-feeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aventure AB Lund Sweden 223 63

Sponsors and Collaborators

  • DoubleGood AB
  • starScience GmbH

Investigators

  • Principal Investigator: Elin Ostman, PhD, Aventure AB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DoubleGood AB
ClinicalTrials.gov Identifier:
NCT04848233
Other Study ID Numbers:
  • DG2101_CGM
First Posted:
Apr 19, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 3, 2021