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

Unilever

Status

Completed

Conditions

Glucose Metabolism Disorders

Treatments

Dietary Supplement: High glycemic load

Dietary Supplement: Low glycemic load

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02926118

REF-CSC-2682

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts 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