Continuous Glucose Monitoring During Diets That Differ in Glycemic Load (GLOW)

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Dietary supplement: Low glycemic load; Dietary supplement: High 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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low glycemic load	Dietary supplement: Low glycemic load; Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
Experimental: High glycemic load	Dietary supplement: High glycemic load; High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carry over of the dietary intervention into the next day	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.	0 - 120 minutes after the standard meal
Carry over as measured in venous blood versus as measured during continuous glucose monitoring	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.	0 - 120 minutes after the standard meal
Post prandial glucose concentration during breakfast, lunch or dinner.	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.	0 - 120 minutes after each of the start of the meal

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Maastricht University
• Investigators: Principal Investigator: Mensink Ronald P, PhD, Maastricht University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2017
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): October 18, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Glucose; Glycemic load; Dietary intervention; Continuous glucose monitor
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: REF-CSC-2682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No