Impact of galacto-oligosaccharides on microbial fermentation capacity and markers of frailty in adults and elderly

The intestines contain large amounts of bacteria which contribute to well
functioning digestive system. Bacteria are involved in breakdown of nutrients,
but also in the immune system of the human body. Previous research has been
shown that dietary fibers are able to modulate the composition of the
microbiota, especially in the large intestine, thereby inducing additional
health effects. In this study, we will investigate the effects of
galacto-oligosaccharide, a dietary fiber which is derived from milk, on
microbial fermentation capacity and markers of frailty in adults and elderly.

This study will be don to gain insights in the effects of the dietary fiber
pectin on gut functioning and the immune system.
The information will gain more insights in the working mechanism of this
specific dietary fiber. Further, we are especially
interested in possible different effects in healthy adults when compared to
elderly people. In case study results will be
positive, this may lead to the development of more and new health promoting
foodproducts. In case there will be different
effects in different age groups, this may lead to new foodproducts targeting
one specific age group.

The study conforms to a randomized, double-blind and placebo-controlled design
including two cross-over intervention periods

Subjects will be randomized into one of the two intervention periods. One
period subjects will receive 7.24 grams of Vivinal GOS supplements three times
daily for four weeks. In the other period, subjects will receive 7.24 grams of
placebo supplements three times daily for four weeks.

There are small burdens volunteers can experience during this study. After the
screening visit, participants will have to visit the Maastricht Universitair
Medisch Centrum+ six times. In total, a participant will spend approximately
three hours at the university facility. They will have to take GOS or placebo
supplements three times daily for a time period of eight weeks; the supplements
used have been proven to be safe for human use. During four visits and spread
over 12 weeks, a total of 76 mL blood (fasted) will be sampled by venepuncture
via an evacuated tube system, which may lead to minor discomfort and/or a small
hematoma at the site of puncture. During the same visits, exhaled air samples
will be collected and subjects will bring a fecal sample which is collected at
home. Moreover, questionnaires will have to be filled out at several occasions
during this study. Besides we ask subjects to fill out a 3-day food diary
before handing in the first fecal sample. When collecting fecal samples later
in the specific study period, we ask subjects to repeat the same food pattern
and record this again in a diary.