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Completed

NCT Number: NCT04848233

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

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.

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Key information

Conditions

Glycemic Control Diet, Food and Nutrition

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aventure AB

Lund, 223 63, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drinks containing 5AA+CrPic and Placebo

Dietary Supplement

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.

Primary outcomes

  1. Postprandial glucose response

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

    Incremental area under the blood glucose curve after each meal

Secondary outcomes

  1. Glycemic variability

    Time frame: 24 hour cycles

    Variation in blood glucose levels

Sponsors and collaborators

Lead sponsor

DoubleGood AB

Industry

Collaborators

  • starScience GmbH

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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