Clinical trial NCT02926118: Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
Official title: Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Keywords: Glucose
Continuous glucose monitor
Glycemic load
Dietary intervention
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Maastricht University
First posted: 2016-10-06
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Post prandial glucose concentration
timeFrame: 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)
Secondary outcomes:
measure: Three-day glucose concentration
timeFrame: From start of dietary intervention until the end 3 days later
measure: Day time glucose concentration
timeFrame: Between 07:00-22:00 h
measure: Night time glucose concentration
timeFrame: Between 22:01-26:59 h
measure: Glucose variability
timeFrame: From start of dietary intervention until the end 3 days later
measure: Comparison of continuous interstitial glucose with venous blood glucose
timeFrame: -30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal
Other outcomes:
measure: Carry over of the dietary intervention into the next day
timeFrame: 0 - 120 minutes after the standard meal
measure: Carry over as measured in venous blood versus as measured during continuous glucose monitoring
timeFrame: 0 - 120 minutes after the standard meal
measure: Post prandial glucose concentration during breakfast, lunch or dinner.
timeFrame: 0 - 120 minutes after each of the start of the meal
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Mensink Ronald P, PhD
role: PRINCIPAL_INVESTIGATOR
References: