The study investigates whether the glycemic response to standardized snacks differs within subjects between different times of the day. The study concerns a pilot for a future larger study of more complex aspects of the nutritional and physical…
ID
Source
Brief title
Condition
- Diabetic complications
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The continuous glucose values **are determined with Dexcom G6 glucose monitors
that the subjects carry with them for 10 days. The primary endpoint of the
study is the difference in the incremental area under the glucose response
curve: the "incremental area under the curve" (iAUC) at different times of the
day around the consumption of standardized snacks. During the entire 10-day
period, the test subjects keep a food diary through an app.
Secondary outcome
To explore the relationship with physical activity and nutrition, the test
subjects also wear an ActiGraph wGT3X BT accelerometer.
Background summary
Reducing glucose level variations through appropriate nutrition could bring
significant health benefits to healthy people. However, glucose response to
diet (glycemic response) varies between individuals, and is also influenced by
factors such as physical activity. It is still unclear to what extent this
response also differs within people in relation to the biological (circadian)
clock.
Study objective
The study investigates whether the glycemic response to standardized snacks
differs within subjects between different times of the day. The study concerns
a pilot for a future larger study of more complex aspects of the nutritional
and physical activity pattern.
Study design
A longitudinal crossover design is used in which subjects are followed for a
total of 10 days. Each subject is its own control in the sense that differences
between the responses at different times within a subject are studied. To
prevent confounding by i.e. time, a randomized block design with three arms is
used. The arms differ in the pattern of the snack moments: only the order of
the times at which standard snacks are taken on the different intervention days
is different.
Intervention
Subjects are followed for a total of 10 days. Six of those 10 days are the
"intervention days" on which the subjects must adhere to rules. Subjects
follow a schedule with set times at which they eat meals and snacks on the 6
intervention days. They then eat a pre-packaged ginger bread bar (the standard
snack) at a set time in the morning, afternoon, or evening. In the two hours
before and after the specified snack time, the subjects are asked not to eat
anything else and only drink water, coffee and / or tea. Furthermore, test
subjects are not allowed to exercise or perform heavy (domestic) tasks during
these intervention days. The subjects follow their own diet on the other days
of the study.
Study burden and risks
Subjects visit the RIVM three times: for an intake interview and to sign
informed consent; to start the investigation and finally upon completion of the
investigation. In addition, they visit a Saltro location to conduct an oral
glucose tolerance test; a tube of blood is taken twice. Subjects are asked to
undergo an oral glucose tolerance test. This test can be experienced as
unpleasant by some people. In addition, the limited risks associated with a
blood test apply. Rules regarding nutrition and exercise are imposed during 6
days. The risks of this study are expected to be minimal. The glucose monitor
and the accelerometer are regularly used for scientific research. The glucose
monitor is also used in the care of patients with diabetes. In the glucose
monitor, mild local reactions to the sensor, such as redness, itching and
bruising, were reported in some of the subjects. Participation in the study
takes the test subject around 20 hours in total. There are no direct personal
benefits for the test subjects. Test subjects receive a travel allowance and an
allowance in the form of a gift voucher of 75 euros when completing the study.
Test subjects can, if they wish, receive a feedback from the personal data
collected during this study. Conducting this pilot study can provide a better
knowledge base on glucose patterns in healthy people and how these are
influenced by diet.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
- BMI 18.5-30 kg/m2
- 18-65 years old
- Subjectively health
Exclusion criteria
- Illiteracy
- Not being able to give informed consent
- Do not have a doctor
- Use of medicines that can influence glucose levels: such as beta-adrenergic
receptor antagonists ('beta-blockers')
- Pregnancy, breastfeeding, women who are actively trying to conceive
- Acute and / or chronic disease that prevents the test subject from adhering
to the research protocol.
- Metabolic and / or hormonal disorders, such as diabetes mellitus
- Swallowing problems, delayed stomach emptying
- Allergies for the standard snack, such as gluten intolerance
- Practicing extreme sports (for example, marathon, triathlon)
- Practicing a very physically demanding job such as in construction.
- Smoking
- Known allergic skin reaction during the use of continuous glucose monitoring
or patches in general
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71117.100.20 |
| OMON | NL-OMON26257 |