Maastricht University
Maastricht, Netherlands
NCT Number: NCT02926118
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.
Looking for future studies?
Notify Me50 year–70 year
All sexes
Interventional
Not applicable
Maastricht, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
Time frame: 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)
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.
Time frame: From start of dietary intervention until the end 3 days later
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared
Time frame: Between 07:00-22:00 h
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared
Time frame: Between 22:01-26:59 h
Difference in glucose concentrations between the low and the high glycemic load diet. Total area under the curve will be compared
Time frame: From start of dietary intervention until the end 3 days later
The Continuous Overall Net Glycemic Action (CONGA) will be calculated.
Time frame: -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal
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
Time frame: 0 - 120 minutes after the standard meal
Difference in glucose (in venous blood) and insulin responses to a standard meal consumed on the day after both the low and high glycemic load diets. 2-hour post prandial Incremental are under the curve for glucose and insulin in venous blood will be calculated.
Time frame: 0 - 120 minutes after the standard meal
Compare the difference in glucose responses to the standard meal on morning after the low and the high glycemic load diet measured in venous blood with the difference as measured in using continuous blood glucose monitor. 2-hour post prandial incremental area under the curve for glucose will be calculated for both methods.
Time frame: 0 - 120 minutes after each of the start of the meal
Difference in post prandial glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after each of the three main meals (breakfast, lunch, dinner) during the three-day dietary interventions will be calculated separately. The three post prandial periods for both low and high glycemic load diet per subject will be combined in separate mixed models for breakfast, a model for lunch and a model for dinner.
Unilever R&D
Industry
Acronym: GLOW
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04571008
Glucose Metabolism Disorders, Metabolic Diseases
St Louis, Missouri, United States
View Trial DetailsNCT06619834
Diabetes Mellitus, Endocrine System Diseases
Ann Arbor, Michigan, United States
View Trial DetailsNCT05014204
Diabetes, Diabetes Mellitus
Los Angeles, California, United States
View Trial DetailsNCT05260021
Diabetes Mellitus, Diabetes Mellitus, Type 2
Los Angeles, California, United States
View Trial Details