18-22 YEAR OLD MALES WIHT A NORMAL WEIGHTExamine the possible attenuating cardiometabolic health effects of (A) hourly, 10-min standing interruptions, when compared to a single bout of prolonged sitting, and (B) sitting on a stability ball, when…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
18-22 YEAR OLD MALES WIHT A NORMAL WEIGHT
The main outcomes of this study are the post-prandial responses of plasma
levels of C-peptide, glucose, triglycerides and high-sensitive C-reactive
protein and pre/post values of cortisol plasma levels.
14-18 YEAR OLD MALES WITH OVERWEIGHT/OBESITY
The main outcomes of this study are the post-prandial responses of plasma
levels of C-peptide, glucose, and high-sensitive C-reactive protein.
For details see document "C2. Amendement".
Secondary outcome
18-22 YEAR OLD MALES WIHT A NORMAL WEIGHT
Secondary outcomes of this study are functioning of the autonomic nervous
system, sleep-wake patterns, attention/concentration and mood.
14-18 YEAR OLD MALES WITH OVERWEIGHT/OBESITY
Secondary outcomes of this study are functioning of the autonomic nervous
system and "C2. Amendement".
For details see document "C2. Amendement".
Background summary
Recent experimental studies demonstrated that, when compared to prolonged
sitting, interruptions during prolonged sitting significantly reduced
postprandial glucose, insulin and C-peptide in healthy young adults. One study
could not establish this in children. Thus far, no studies have examined the
possible positive effects of standing interruptions to prolonged sitting or
active sitting. Moreover, to date, no studies are performed in overweight/obese
children, who may be at increased risk for cardiometabolic ill-health. This
information is essential to inform preventive interventions and guidelines on
sedentary behaviour in children.
Study objective
18-22 YEAR OLD MALES WIHT A NORMAL WEIGHT
Examine the possible attenuating cardiometabolic health effects of (A) hourly,
10-min standing interruptions, when compared to a single bout of prolonged
sitting, and (B) sitting on a stability ball, when compared to a single bout of
prolonged sitting, in healthy young males.
14-18 YEAR OLD MALES WITH OVERWEIGHT/OBESITY
Examine the possible attenuating cardiometabolic health effects of (A) 10-min
standing interruptions every 30 min, when compared to a single bout of
prolonged sitting, and (B) 4-min cycling interruptions every 30 min, when
compared to a single bout of prolonged sitting, in overweight/obese young males.
For details see document "C2. Amendement".
Study design
18-22 YEAR OLD MALES WIHT A NORMAL WEIGHT
Experimental study with a cross-over design, including three experimental
conditions, lasting 5 hours each:
1) prolonged sitting on a lounge chair;
2) prolonged sitting on a lounge chair with hourly 10-min standing
interruptions;
3) active sitting on a stability ball.
14-18 YEAR OLD MALES WITH OVERWEIGHT/OBESITY
Experimental study with a cross-over design, including three experimental
conditions, lasting 5 hours each:
1) prolonged sitting on a lounge chair;
2) prolonged sitting on a lounge chair with 10-min standing interruptions every
30 min;
3) prolonged sitting on a lounge chair with 4-min cycling interruptions every
30 min, at a moderate intensity.
For details see document "C2. Amendement".
Study burden and risks
There are no expected risk or benefits in the present study. Participants will
visit the laboratory three times in a fasted state. After the first venous
blood sample is collected, they will receive a standardized meal. Venous blood
samples (6 samples in total) will be collected hourly using an in-dwelling
catheter. Additionally, autonomic functioning (non-invasive; pre, halfway,
post), attention/concentration (pre, halfway, post) and mood (hourly) will be
measured. Muscle activity will be measured hourly using surface electrodes at
the belly of the indicated muscles. These methods are safe, frequently used and
will be executed by trained and qualified researchers. The experimental
conditions include very common daily activities and do not possess any
potential risk either. There is minimal risk for the participants.
Nevertheless, vial broaching can induce pain for the participants.
Additionally, the time investment (5,5 * 6 hours per visit) can be a burden for
the participants.
van der Boechorststraat 7 kamer C575
Amsterdam 1081 BT
NL
van der Boechorststraat 7 kamer C575
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
NORMAL WEIGHT MALES:
Apparently healthy normal weight (20 subjects) males aged 18-22 years; or overweight/obese (BMI *25/30; 20 subjects) males aged 14-18 years; Dutch or English speaking; Signed informed consent from the participant (males aged 16-18 years) and signed informed consent from the participant and one of his parents (males aged 14-15 years).
Exclusion criteria
Major acute illness/injury; Physical problems that may limit the ability to perform the experiment (i.e. the standing or cycling interruptions or sitting on a stability ball); having diabetes mellitus type II.
Design
Recruitment
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 | NL51407.029.15 |
OMON | NL-OMON20679 |