To test the effect of replacing sugar containing beverages by *diet* beverages containing non-caloric sweeteners on body weight and fat mass in school children aged 5-10 years. In addition we will examine the food intake of all participants at lunch…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
overgewicht/obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the study are the children*s bodyweight (body mass
index, corrected for age), waist circumference, skin folds and bioelectrical
impedance. These outcomes will be measured four times during the study, at the
start, after 6, 12 months and at the end of the study. As a secondary outcome
we will also assess food intake of the children at lunch time, shortly after
the morning break when the children have consumed the study drinks. This
outcome will be measured at the start and at the end of the study.
Secondary outcome
As a secondary outcome we will also assess food intake of the children at lunch
time, shortly after the morning break when the children have consumed the study
drinks. This outcome will be measured at the start and at the end of the study.
Background summary
Liquid carbohydrates (including soft drinks as well as fruit juices) are
thought to be less satiating then solid carbohydrates (e.g. bread or fruits).
Calories from sugary drinks might not be compensated for by eating less at
subsequent meals. In this way liquid carbohydrates might be one of the causes
of overweight and obesity in children. However government policies to reduce
intake have been less than firm. One reason may be that the evidence for an
effect of sugary drinks on body weight rests mostly on observational
epidemiological studies and a few short term interventions. Therefore, we
propose the first double-blind, long term, randomized controlled trial. The
hypothesis of this trial is that intake of liquid carbohydrates is not
compensated for sufficiently by reducing caloric consumption for other foods.
This leads to incomplete compensation for the energy ingested and eventually
results in the excess weight gain.
Study objective
To test the effect of replacing sugar containing beverages by *diet* beverages
containing non-caloric sweeteners on body weight and fat mass in school
children aged 5-10 years. In addition we will examine the food intake of all
participants at lunch time. This trial is a strict test of the physiological
effects of liquid carbohydrates on body weight. Changes in body weight due to
social and psychological cues and expectations will be eliminated since the
trial is blinded.
Study design
A double-blind, long term, randomized controlled trial
Intervention
Six hundred healthy children (5-10 years) will be divided randomly into 2
groups. Group 1 (n=300) receives 250 mL per day of sugar-containing drinks
(Unilever peach drink, Unilever mango drink, Unilever lemon drink). Group 2
(n=300) receive 250 mL per day of light drinks (Unilever peach drink light,
Unilever mango drink light, Unilever lemon drink light). The drinks for group 2
are identical looking. The light drinks are sweetened with artificial
sweeteners. The drinks will be consumed during the morning break during the
weekdays at school and at home during weekends and holidays. The intervention
period for both groups will be 18 months.
Study burden and risks
All drinks are safe. The amounts of artificial sweeteners in the light drinks
are in accordance with governmental regulations for foods and drinks. The
measurements are non-invasive and there are no risks associated to these
measurements. There is no direct clinical benefit from participating in this
study. However this trial might have a decisive impact on policy and medical
practise and lead to effective interventions that contribute to the prevention
of overweight and obesity in children.
De Boelelaan 1085
1081HV
NL
De Boelelaan 1085
1081HV
NL
Listed location countries
Age
Inclusion criteria
- Healthy school going boys and girls
- Age 5 years and older, children still have to be in elementary school at the end of the study.
- Children who already habitually consume 250 mL per day or more of sugary drinks.
Exclusion criteria
- Using medication or under medical treatment for obesity
- Any acute or chronic disease such as diabetes, grow disorders, celiac disease, or serious gastro-enterology (for example inflammatory bowel disease).
- Medical history or surgical events known to interfere with the study
- Participation in another intervention trial up to 3 months before and during the study if the intervention interferes with the current study
- Physical disabilities that hamper the measurements
- Intention to change location of residence and primary school during the study period
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 |
|---|---|
| CCMO | NL26880.029.09 |