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CompletedNCT04848233Updated Nov 22, 2022

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

An interventional study of Drinks containing 5AA+CrPic and Placebo in Glycemic Control and Diet, Food and Nutrition, sponsored by DoubleGood AB. Completed at 1 site in Sweden. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.

Sponsored by DoubleGood AB · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glycemic Control
  • Diet, Food and Nutrition
03

In context

Lead sponsor

DoubleGood AB is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Postprandial glucose response

    Incremental area under the blood glucose curve after each meal

    Time frame: From start of meal (0 min) to 120 min postprandially

Secondary outcomes

  1. Glycemic variability

    Variation in blood glucose levels

    Time frame: 24 hour cycles

07

Study locations

1 site
  • Aventure AB
    Lund, 223 63, Sweden
08

References and documents

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. PubMed 36062264 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04848233
Lead sponsor
DoubleGood AB
Collaborators
starScience GmbH
Responsible party
Sponsor
First posted
Apr 19, 2021
Start date
Apr 20, 2021
Primary completion
May 26, 2021
Completion
May 26, 2021
Last update
Nov 22, 2022

Study contacts

Elin Ostman, PhD
principal investigator · Aventure AB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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