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

Not Applicable

Completed

• Conditions: Glycemic Control; Diet, Food and Nutrition
• Interventions: Dietary Supplement: Drinks containing 5AA+CrPic and Placebo

• Registration Number: NCT04848233
• Lead Sponsor: DoubleGood AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Study Start: 2021-04-20
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drink intervention	Drinks containing 5AA+CrPic and Placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Glycemic variability	24 hour cycles	Variation in blood glucose levels

Trial Locations

Locations (1)

Aventure AB; 🇸🇪 Lund, Sweden