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

DoubleGood AB6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Glycemic Control Diet, Food and Nutrition

Interventions

Drinks containing 5AA+CrPic and PlaceboDIETARY_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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Aventure AB

Lund, Sweden

Outcomes

Primary Outcomes

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

Glycemic variability

Variation in blood glucose levels

Time frame: 24 hour cycles

Data from ClinicalTrials.gov

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