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

Primary Purpose

Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Low glycemic load
High glycemic load
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders focused on measuring Glucose, Continuous glucose monitor, Glycemic load, Dietary intervention

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low glycemic load

High glycemic load

Arm Description

Low glycemic load

High glycemic load

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
Glucose variability
The Continuous Overall Net Glycemic Action (CONGA) will be calculated.
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

Full Information

First Posted
October 5, 2016
Last Updated
October 18, 2017
Sponsor
Unilever R&D
Collaborators
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT02926118
Brief Title
Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
Acronym
GLOW
Official Title
Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
July 13, 2017 (Actual)
Study Completion Date
October 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders
Keywords
Glucose, Continuous glucose monitor, Glycemic load, Dietary intervention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low glycemic load
Arm Type
Experimental
Arm Description
Low glycemic load
Arm Title
High glycemic load
Arm Type
Experimental
Arm Description
High glycemic load
Intervention Type
Dietary Supplement
Intervention Name(s)
Low glycemic load
Intervention Description
Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
High glycemic load
Intervention Description
High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
Primary Outcome Measure Information:
Title
Post prandial glucose concentration
Description
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
0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)
Secondary Outcome Measure Information:
Title
Three-day glucose concentration
Description
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
Title
Day time glucose concentration
Description
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
Title
Night time glucose concentration
Description
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
Title
Glucose variability
Description
The Continuous Overall Net Glycemic Action (CONGA) will be calculated.
Time Frame
From start of dietary intervention until the end 3 days later
Title
Comparison of continuous interstitial glucose with venous blood glucose
Description
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
-30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal
Other Pre-specified Outcome Measures:
Title
Carry over of the dietary intervention into the next day
Description
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
Title
Carry over as measured in venous blood versus as measured during continuous glucose monitoring
Description
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 the standard meal
Title
Post prandial glucose concentration during breakfast, lunch or dinner.
Description
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.
Time Frame
0 - 120 minutes after each of the start of the meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mensink Ronald P, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Continuous Glucose Monitoring During Diets That Differ in Glycemic Load

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