Obesity Clinical Trial
Official title:
Acceptability of Dietary Fibre-based Foods to Reduce Dietary Fat Uptake
Obesity is a wide reaching problem in the United Kingdom. The most widely used obesity
therapies are based around drugs that reduce dietary fat digestion, and thereby reduce uptake
of calories from the diet. While such therapies have proved effective, patient compliance is
low due to the unwanted gastrointestinal side effects of these drugs. Dietary fibre is
generally classified as dietary material of plant origin that is indigestible to humans.
Dietary fibre is in fact a wide range of different compounds that have varied effects on the
human body. Initial findings from this laboratory suggest that some types of fibre can
greatly reduce the rate that fat is digested and absorbed in the gut.
Whether such fibre-based test foods are acceptable (i.e. taste good, are easy to include in
the diet and do not cause any unwanted gastrointestinal side effects) will be assessed in
longer term studies. To carry these studies out, healthy adults will be recruited.
Participants will attend an induction visit and will be asked to keep a food diary, and fill
out daily questionnaires on general well-being and feelings of fullness over a two-week
period whilst consuming the standard white bread given to them. Following this two-week
period, participants will attend the study centre again. At this time, participants will be
provided with dietary fibre-based study food (bread) to substitute into their standard diet
over the following two weeks (further bread will be provided as and when required).
Participants will fill out the same diaries and questionnaires as before over the first two
week period.
This study aims to test the acceptability of fibre-based foods in terms of their
palatability, ease of incorporation into the diet and the lack of unwanted side effects of
consumption. To meet these aims, participants will be provided with bread to incorporate into
their diet (by substituting like-for-like) over a two-week period. During this time,
participants will record what they have eaten, along with their general feelings of
well-being throughout this period. These measures will be compared to the same data collected
over the two-week period prior to giving the participants the study foods (as a "background"
measure of food intake and general well-being).
To carry these studies out, healthy adults will be recruited. Participants will attend an
induction visit at Newcastle University where we will take informed consent. Participants
will then be asked to keep a food diary, and fill out daily questionnaires on their general
well-being and feelings of fullness for the entirety of the following two weeks whilst
consuming the standard white bread given to them. Following this two-week period,
participants will attend the study centre again and will be provided with dietary fibre-based
study food (breads) to substitute into their standard diet over the following two weeks
(further foods will be provided as and when required). They will fill out the same diaries
and questionnaires as they did before over the first two week period.
The wellbeing questionnaire will be filled out by participants every day with a more detailed
questionnaire completed at the end of each week. Volunteers will complete the more detailed
questionnaire five times. Once at the start of the study (baseline) and then at then once at
the end of each week consuming standard white bread and once at the end of each week
consuming the alginate bread. The standard wellbeing questionnaire will be completed every
day the volunteers are on the study.
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