Continuous Glucose Monitoring During Diets That Differ in Glycemic Load

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders
• Interventions: Dietary Supplement: Low glycemic load; Dietary Supplement: High glycemic load

• Registration Number: NCT02926118
• Lead Sponsor: Unilever R&D

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2017-04-27
• Primary Completion: 2017-07-13
• Status Verified: 2017-10
• Study Completion: 2017-10-18
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low glycemic load	Low glycemic load	Low glycemic load
High glycemic load	High glycemic load	High glycemic load

Primary Outcome Measures

Name	Time	Method
Post prandial glucose concentration	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.

Secondary Outcome Measures

Name	Time	Method
Three-day glucose concentration	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
Day time glucose concentration	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
Glucose variability	From start of dietary intervention until the end 3 days later	The Continuous Overall Net Glycemic Action (CONGA) will be calculated.
Comparison of continuous interstitial glucose with venous blood glucose	-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
Night time glucose concentration	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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands