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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2021-05-26

Brief Summary

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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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Detailed Description

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Conditions

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Glycemic Control Diet, Food and Nutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Drinks containing 5AA+CrPic and Placebo

Intervention Type 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.

Interventions

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Drinks 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes