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

DoubleGood

Status: Completed

Conditions: Diet, Food and Nutrition; Glycemic Control

Treatments: Dietary Supplement: Drinks containing 5AA+CrPic and Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04848233

DG2101_CGM

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Drink intervention

Other group

Description:

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.

Treatment:

Dietary Supplement: Drinks containing 5AA+CrPic and Placebo