to assess the effect of 21 days of consumption of 5.5 g GOS powder on the gut comfort component score (based on 5 questions), as compared to a control group receiving maltodextrin (control product).
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter is a component score of gut comfort feelings based on 5
questions regarding bloating, flatulence, stomach ache, constipation and
diarrhea of the past 7 days (each answer ranging from 0 -3; thus component
score can range from 0-15).
Secondary outcome
The secondary objectives are to assess the effects of GOS on the component
score of gut comfort at days 4 and 14 and the shifts in microbial composition
after 21 days.
Background summary
Prebiotics are important in steering the intestinal microbiota composition, and
by doing so they can play an important role in the relief of *general* gut
complaints (not linked to a specific disease). Galacto-oligosaccharides (GOS)
is a lactose derived prebiotic and fermented in particular by, and thus
stimulating, bifidobacteria and lactobacilli. Besides a possible effect on gut
complaints, emerging evidence finds a link between microbiota and brain
function, known as the microbiome-gut-brain axis, affecting the regulation of
the stress hormone cortisol and sleep quality. Limited studies of GOS on
general gut complaints have been performed in humans, whereas the combination
of gut complaints, stress and sleep probably is unique.
Study objective
to assess the effect of 21 days of consumption of 5.5 g GOS powder on the gut
comfort component score (based on 5 questions), as compared to a control group
receiving maltodextrin (control product).
Study design
Double-blind placebo controlled intervention study
Intervention
The intervention group receives 5.5 g GOS in powder form. The control group
receives the same amount of maltodextrin powder. Both groups need to use these
powder supplements, portion packed in sachets, daily for 21 days. The powders
can be added to a dairy product (e.g. yogurt, quark) or to a glass of water,
tea or coffee, and have to be consumed with the first meal of the day.
Study burden and risks
The risks involved in participating in this experiment are low. The GOS and
maltodextrin powders are food-grade and will be produced under Good
Manufacturing Practices in certified facilities and using approved and
commercially available ingredients, in amounts that have been used more often
without difficulties. Next to using the powders for 21 days in their normal
dietary pattern, participants are asked to fill out four times an online
questionnaire each taking about 15 minutes and to collect a faecal sample at
the start and at the end of the study. The total burden of these activities is
low and results in important information necessary to answer our research
question on self-perceived health benefits.
Bronland 20
Wageningen 6708 WH
NL
Bronland 20
Wageningen 6708 WH
NL
Listed location countries
Age
Inclusion criteria
- Female
- 25 - 45 years of age
- Component (summed) score for gut complaints * 6 (based on bloating,
flatulence, stomach ache, constipation, diarrhea)
Exclusion criteria
- Any medical diagnosed disease underlying gut-related complaints, including
Irritable Bowel Syndrome, celiac disease, Crohn*s disease, colitis,
haemorrhoids, cancer, and/or any other disease considered relevant as
determined during screening.
- Use of antibiotics, opiates, anti-inflammatory drugs (NSAIDs) and/or
metformin, and/or other medication that are known to affect the composition of
the gut microbiota during the 14 days before inclusion.
- Pregnant or lactating.
- Self-reported lactose intolerance
- Self-reported cow*s milk protein allergy.
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 |
|---|---|
| Other | Bij akkoord registreren we het bij NTR |
| CCMO | NL73755.041.20 |