To assess the ability of the CGM device to monitor differences in glucose concentrations during two diets, that differ in glycemic load (GL).
ID
Source
Brief title
Glucose LOWering
Condition
- Other condition
Synonym
Health condition
Metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in 2-hour postprandial glucose concentrations between the low GL
and the high GL diets, as measured with the CGM device. For this, the positive
incremental area under the curve during two hours (+iAUC0-2h) after the three
main meals (breakfast, lunch, dinner) for each of the three days of each
dietary period will be calculated.
Secondary outcome
Differences in glucose concentrations between the low and the high GL diets as
quantified by the total area under the curve (tAUC) for the full 3 days and
also for daytime [07:00-22:00] and night-time [22:01-06:59]; the difference in
glucose variability between the low and the high GL diets; and the agreement
between venous plasma glucose concentrations and CGM values.
Background summary
Larger increases in blood glucose during the postprandial state may contribute
to the risk for developing chronic disease. Historically, glucose was measured
in blood collected by finger sticks but recently Continuous Glucose Monitoring
(CGM) devices have been developed for diabetes patients. These devices measure
glucose in the interstitial fluid for several days and report glucose
concentrations that mirror those in capillary blood. A CGM device that has
become available very recently is smaller, easier to wear, collect data for
longer periods and does not require frequent calibration against fingersticks
anymore. That should make this device ideal for use in healthy subjects during
dietary interventions.
Study objective
To assess the ability of the CGM device to monitor differences in glucose
concentrations during two diets, that differ in glycemic load (GL).
Study design
Single-blind (those collecting and analysing data), randomized, cross-over
study comparing two diets varying in glycemic load. Subjects will consume both
diets for three days separated by a washout/recovery of 2* days.
Intervention
Subjects will receive a low and a high glycemic load diet in random order.
Contrast in the intakes of available carbohydrates and glycemic index of those
diets will be maximised within the limits of what can still be considered a
normal diet by using off the shelf food and beverage products.
Study burden and risks
Before the start of the study subjects will be screened to determine
eligibility during one 20 min visit. At screening, body weight, and height will
be measured and a blood sample (2 mL) will be drawn via venapunction. Subjects
will be asked to fill in a medical and general questionnaire, including
information on physical activity. The study starts with an instruction meeting
(30 min) and the application of the CGM sensor (30 min). Subjects will receive
food items differing in glycemic load and will be instructed to substitute
these products into their habitual diets during two periods of three days. They
will be asked to wear an activity tracker during those two periods. The
subjects will also participate in two postprandial tests immediately after the
two dietary interventions. After arriving at the university in a fasted state,
an intravenous cannula will be inserted into their antecubital vein. Before and
after consumption of a meal consisting of 200 grams white rice, eighteen blood
samples (nine samples of 2 ml for plasma glucose and nine samples of 4 ml EDTA
samples for plasma insulin) will be drawn during a five hour period. Subjects
will be asked to keep a study-diary during both dietary interventions of three
days each, registering intake of food and beverages, as well as any signs of
illness, medication used, and any deviations from the protocol. Blood sampling
might cause some bruising or hematoma. In very rare cases the adhesive of the
CGM may cause allergic reactions. Total time investment for the subjects will
be approximately 12 hours.
Olivier van Noortlaan 120
Vlaardingen 3130 AC
NL
Olivier van Noortlaan 120
Vlaardingen 3130 AC
NL
Listed location countries
Age
Inclusion criteria
- Apparently healthy men and post-menopausal women (post-menopausal for at least one year)
- BMI >= 25.0 and <= 35.0 kg/m2
- Age: 50-70 yrs
- Signed informed consent
Exclusion criteria
- Having a medical conditions which might affect the study measurements.
- Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements.
- Use of oral antibiotics 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.
- Reported intense sporting activities > 2h/w.
- 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.
- Reported dietary habits: medically prescribed diet, slimming diet, vegetarian.
- Reported weight loss/gain (> 3 kg) in the last 2 months before the study.
- Blood donation in the past 3 months
- Known allergy or intolerance to food products.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02926118 |
| CCMO | NL58974.068.16 |