Objective: Foods consisting of locally grown seasonal vegetables, beef, whole milk and dairy butter with a balanced composition of omega 3 and 6 fatty acids and a wide range of essential micronutrients positively influences the developing immune…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: a decrease in TRACK scores and LRSQ scores of
the dietary intervention group compared to the control group.
Secondary outcome
Secondary outcome measures are medication use, microbiome, immune analysis
(cytokine profile, selective antibody production), IgA in saliva, adherence to
the diet as well as growth parameters such as height, weight and Body Mass
Index (BMI).
Background summary
Rationale: Genetic factors for asthma are potentially present, but depending on
internal and environmental factors whether the disease actually manifests
itself. Nutrition in children affects the growth and development of the body.
Nutrition can play a role in immunological stabilisation or derailment of the
immune system. The immune system is thought to be a regulator of asthma and
airways inflammation by producing too many immune factors in response to a
stimuli that should not cause such a reaction.
Can nutrition in the young child stabilize the immune system and by that be one
of the factors that can influence the onset of asthma?
Study objective
Objective: Foods consisting of locally grown seasonal vegetables, beef, whole
milk and dairy butter with a balanced composition of omega 3 and 6 fatty acids
and a wide range of essential micronutrients positively influences the
developing immune system of a child. Therefore, can it have a protective effect
on the development of asthmatic complaints in young children (1-4 years)
expressed in reduced TRACK and LRSQ scores?
Our secondary objective is to see changes in immunological parameters and the
microbiome between the intervention group and the control group.
Study design
Study design: a randomized controlled multicentre trial
Intervention
Intervention: a dietary advice of four unprocessed food products (NOVA 1or 2
classification foods);
300 ml full fat (3.4%) milk or yoghurt per day, 5 grams of butter per slice of
bread, about 100 grams of seasonal vegetables and 50-60 grams of beef. The
dietary intervention will be followed for 6 months.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: We intend to conduct an intervention study in
young children (1-4 years) with asthmatic symptoms and a high risk of
developing asthma. The study will focus on the preventive effect of a
nutritional intervention. Currently, there is no preventive strategy to prevent
asthma in high-risk children. This study can contribute to the development of a
strategy with the intention to prevent a chronic disease or reducing
respiratory symptoms.
previous studies have shown that the dietary advice can be well followed by
parents (>75%).
There are no additional risks associated with participating in this study
Geerdinksweg 141
Hengelo 7555 DL
NL
Geerdinksweg 141
Hengelo 7555 DL
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are;
- Children between 1 and 4 years old
- Paediatric Asthma Score is 7 or above 7, with these scores there is a high
chance of developing asthma (chance>25%).
Exclusion criteria
-not understanding the Dutch language by the parents
-a cow's milk protein allergy (or any other allergy to one of the components of
the food intervention) at the time of the intervention. If patients never
consumed cow*s milk proteins before, the risk of an allergy is unclear. In that
case they cannot be included. If they have proven to tolerate cow*s milk
protein in whatever form, they can be included.
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 | NL73584.100.20 |