To this end, two study protocols have been developed, one concerning the *target group* of overweight children (aged 12-16), only including non-invasive measurements, and one targeting adult overweight participants (aged 18-45), allowing for…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Volwassenen met overgewicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Post prandial:*
- substrate oxidation
*- energy expenditure
*- hunger and satiety feelings
*- vascular function
- levels of blood glucose, insulin, triacylglycerol (TAG) and free fatty acids
(FFA).
Secondary outcome
N/A
Background summary
Consuming a healthy diet is essential to prevent chronic diseases. There is a
large body of evidence that consuming whole-grain bread reduces the risk of
developing cardiovascular disease (CVD), type 2 diabetes and certain types of
cancer. In addition, it seems to have beneficial effects on body weight
management and may therefore prevent the development of overweight. Despite
many recommendations it seems very difficult to change eating behavior,
reflected in an ever-increasing prevalence of obesity, diabetes and CVD. Also,
there is a global concern about the impact of high sodium intakes and the
development of high blood pressure, a major risk factor for coronary heart
disease and stroke. In the Netherlands, the highest contribution of food to
salt intake is by bread consumption. However, reducing bread salt content is a
real challenge. On the one hand because of the required role of sodium in the
dough preparation, on the other hand because of very poor sensory perception
leading to clear disliking and non-consumption of low salt bread.*Apart from
developing healthier food compositions, tackling overweight should above all
happen at a family- and school behavioral level, where the role of parents,
teachers and *childhood food and drink environment* are expected to be crucial
factors. In the present study, the metabolic effects of a whole grain bread for
children (HB) will be investigated. More specific, the oxidative, satiety- and
quantitative food intake responses of consuming HB will be compared to the
effects of white bread (WB; control).
Study objective
To this end, two study protocols have been developed, one concerning the
*target group* of overweight children (aged 12-16), only including non-invasive
measurements, and one targeting adult overweight participants (aged 18-45),
allowing for invasive metabolic measurements.*Although we expect that metabolic
responses differ between children and adults, it is for ethical reasons not
feasible to collect blood samples in children to study metabolic responses in
more detail. In another part of the work, executed by the faculty of FPNS,
children of similar age will be tested for perceptions related to taste, flavor
and mouth feel. This will yield relevant information, representative of this
age group. Nevertheless, the other leg of this work (separate METC protocol),
which will address study in adults, will give us important additional
information about the potential beneficial metabolic effects of HB vs. WB, in
particular related to the obese body physique. *The present METC protocol,
related to study in overweight adults, will investigate the metabolic effects
of HB vs. WB using both non-invasive and invasive measures.
Although we expect that metabolic responses differ between children and adults,
it is for ethical reasons not feasible to collect blood samples in children to
study metabolic responses in more detail. Accordingly, this study in adults
will give us important additional information about the potential beneficial
metabolic effects of HB vs. WB, in particular related to the overweight body
physique.
Study design
Randomized cross over intervention n=18. Comparing the effects of a white bread
based meal to the effects of a wholegrain based bread meal*.
Intervention
Participants will be provided with different bread meals on 2 separate test
days (in random order). Bread meals will consist of healthbread4kids (HB) or
brown bread (BB) with strawberry jelly or chocolate paste (each participant
will get the same spread on both test days). Pre- and postprandial metabolism
(in response to the different bread meals) will be measured (see primary study
parameters/outcome of the study).
Study burden and risks
The burden of the proposed research is minimal. An intraveneus catheter will be
placed on both test days and on each test day, 8 samples of blood will be
obtained via this catheter (a maximum of 10 mL blood / sample will be
obtained). The only risks associated with participation are the risks related
to blood samples, which are minimal.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
• Blood pressure: diastolic blood pressure between 60 and 90 mmHg and a systolic
bloodpressure between 100 and 150 mmHg
• Body Mass Index > 28 (overweight) (BMI: bodyweight/length2)
• Protein and glucose are not allowed to be present in urine that will be collected during
the screening.
• Subjects have to be healthy (self reported) and are not allowed to use any medication
Which can interfere with the current study.
• Normal Dutch dietary eating habits (no vegan, vegetarian or macrobiotic lifestyle)
Exclusion criteria
• Having a history of medical events that may significantly affect the
study outcome (gastro-intestinal diseases)
• Having regularly gastro-intestinal complaints (stomach upsets, diarrhea,
constipation, wind, abdominal colic) without clear medical cause
• Any current metabolic or endocrine disease
• Diabetes Mellitus (type I and II)
• Reported intolerance for gluten and lactose
• Recent weight loss or gain of >2kg without clear reason
• Reported slimming or medically prescribed diet
• Reported vegan, vegetarian or macrobiotic lifestyle
• Use of antibiotics during the last three months
• Pregnancy
• More than 28 consumptions of alcohol a week (for men) and more than 21 consumptions of alcohol a week (for women)
Design
Recruitment
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL43613.068.13 |