Continuous Glucose Monitoring During Diets That Differ in Glycemic Load

Study Overview
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Brief Summary
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This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.

Detailed Description
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The aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. We will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.

Official Title
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Continuous Glucose Monitoring During Diets That Differ in Glycemic Load

Conditions
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Glucose Metabolism Disorders

Intervention / Treatment
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* Dietary Supplement: Low glycemic load
* Dietary Supplement: High glycemic load


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy males and post-menopausal females Age at start of the study ≥ 50 and ≤ 70 years Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2 Fasting blood glucose value of subjects is ≥ 3.4 and < 6.1 mmol/L at screening Being used to eat three meals a day Having a general practitioner Agreeing to be informed about medically relevant personal test-results by a physician Accessible veins on arms as determined by examination at screening. Exclusion Criteria: Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator Use of oral antibiotics in 40 days or less prior to the start of the study Reported participation in another nutritional or biomedical study 3 months before the screening or during the study Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am Reported intense sporting activities > 2h/w. Intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation Reported alcohol consumption > 10 units/week (female) or > 14 units/week (male) Reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself Reported dietary habits: medically prescribed diet, slimming diet, vegetarian Reported weight loss/gain (> 3 kg) in the last 2 months before the study Being an employee of Unilever or research departments in NUTRIM or the Maastricht University Medical Centre (MUMC+) collaborating in this study Known allergy or intolerance to food products. Blood donation in the past 3 months

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low glycemic load<br>Low glycemic load | Dietary Supplement: Low glycemic load<br>* Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days<br>|
| Experimental: High glycemic load<br>High glycemic load | Dietary Supplement: High glycemic load<br>* High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post prandial glucose concentration | Difference in glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after the three main meals (breakfast, lunch, dinner) during both dietary interventions will be calculated. The nine post prandial periods for both low and high glycemic load diet per subject will be combined in the mixed model. | 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-day glucose concentration | Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared | From start of dietary intervention until the end 3 days later | 
| Day time glucose concentration | Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared | Between 07:00-22:00 h | 
| Night time glucose concentration | Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared | Between 22:01-26:59 h | 
| Glucose variability | The Continuous Overall Net Glycemic Action (CONGA) will be calculated. | From start of dietary intervention until the end 3 days later | 
| Comparison of continuous interstitial glucose with venous blood glucose | Bland-Altman plots of venous blood glucose plotted against the continuous interstitial glucose at the closest available time point. Standard meal will be 200 grams of rice consumed on the day after both the low and high glycemic load diets | -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose, Continuous glucose monitor, Glycemic load, Dietary intervention