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…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intestinal permeability
Gut permeability test in which the 24-hour urinary excretion of test substances
(i.e. sucrose, lactulose, rhamnose, sucralose and erythritol) will be measured
in two separate fractions (0-5 hours and 5-24 hours).
Measurement for intestinal permeability will take place at baseline and after
the supplementation period of four weeks.
Secondary outcome
Intestinal barrier functioning:
• Tight junction structure and proteins in colonic biopies: immunofluorescent
labelling and polymerase chain reaction (PCR) quantification of ZO-1, claudin-3
and occludin. Measurements of tight junction structure and proteins in colonic
biopsies will take place only after the supplementation period of four weeks.
• Ussing chamber experiments in colonic biopsies: transepithelial electrical
resistance (TEER), fluorescein- and horseradish peroxidase (HRP) flux. Ussing
chamber experiments in colonic biopsies will take place only after the
supplementation period of four weeks.
• Histology in colonic biopsies by staining mucus/mucins. Histologic assessment
of colonic biopsies will take place only after the supplementation period of
four weeks.
• MicroRNA 29a (MiR-29a) in colonic biopsies. Measurements of MiR-29a will take
place only after the supplementation period of four weeks.
• Zonulin in blood plasma. Measurements of zonulin will take place at baseline
and after the supplementation period of four weeks.
Immune system performance
• Immune cell infiltration by transcriptomics in colon biopsies. Measurements
of immune cell infiltration will take place only after the supplementation
period of four weeks.
• T-cells and natural killer cells (NK-cells) assessed in PBMC stimulated blood
and measured by fluorescence-activated cell sorting (FACS). Measurements of
T-cells and NK-cells will take place at baseline and after the supplementation
period of four weeks.
• Mononuclear cells and platelets in blood plasma. Measurements of mononuclear
cells and platelets will take place at baseline and after the supplementation
period of four weeks.
• Cytokines and chemokines in 24h stimulated whole blood. Measurements of
cytokines and chemokines will take place at baseline and after the
supplementation period of four weeks.
• C-reactive protein (CRP) in blood serum. Measurements of CRP will take place
at baseline and after the supplementation period of four weeks.
• Secretory Immunoglobulin A (sIgA) in blood serum, feces and saliva.
Measurements of sIgA will take place at baseline and after the supplementation
period of four weeks.
Microbial composition and -function
• Microbial composition in luminal content and feces as measured by Illumina
sequencing. Measurements of microbial composition will take place at baseline
and after the supplementation period of four weeks.
• Short-chain fatty acids in luminal content and feces as measured by
high-performance liquid chromatography (HPLC). Measurements of short-chain
fatty acids will take place at baseline and after the supplementation period of
four weeks.
Metabolite production
• Volatile organic compounds in exhaled air as measured by gas chromatography
time-of-flight mass spectrometry (GC-tof-MS). Measurements of volatile organic
compounds will take place at baseline and after the supplementation period of
four weeks.
Digestive parameters
• Symptom diary questionnaire. The symptom diary questionnaire will be
completed three days prior to the supplementation period and three days during
the last week of the supplementation period.
• Stool frequency and consistency (Bristol Stool Scale) questionnaire. The
Bristol Stool Scale will be completed at baseline and every week during the
supplementation period of four weeks.
• Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS will be
completed at baseline and every week during the supplementation period of four
weeks.
Background summary
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 moduclate the composition of the
microbiota, especially in the large intestine, thereby inducing additional
health effects. In this study, we will investigate the effects of pecin, a
dietary fiber which is naturally present in apple, citrusfruit and sugar beet,
on intestinal barrier function. Further, we will investigate the the effects of
pectin on microbial composition, degradition products and the immune system. In
all these effects we are especially interested in the difference between
healthy adults and healthy elderly.
Study objective
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.
Study design
The study conforms to a randomized, double-blind and placebo-controlled design
including two parallel arms
Intervention
Subjects will be randomized into one of the two groups. One group will receive
7.5 grams of pectin supplements twice daily for four weeks. A second group will
receive 7.5 grams of placebo supplements twice daily for four weeks. Before and
after the supplementation period, several measurements will take place.
Study burden and risks
There are several burdens volunteers can experience during this study. After
the screening visit, participants will have to visit the Maastricht
Universitair Medisch Centrum+ (MUMC+) four times. A participant will spend
approximately eight hours at the university facility. They will have to take
pectin or placebo supplements twice daily for a time period of four weeks; the
supplements used have been proven to be safe for human use. During two visits,
a total of 52 mL blood 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, saliva samples and exhaled air samples
will be collected and subjects will bring a fecal sample which is collected at
home. Furthermore, a gut permeability test will be performed twice for which
subjects will have to ingest a sugar drink and will have to collect their
urinary output for 24 hours and return this to the MUMC+. Moreover,
questionnaires will have to be filled out at several occasions during this
study. A subset of the participants will visit the MUMC+ for a fifth time to
undergo a standard flexible sigmoidoscopy, during which biopsies will be taken
and intestinal fluid contents will be sampled. These procedures bear a small
risk (0.09%) of bowel perforation or bleeding at biopsy sites in general
clinical use, however, the risk in the present study is expected to be much
smaller, because instead of patients who undergo sigmoidoscopy for clinical
reasons, healthy subjects without intestinal disease or other clinical
indication will be investigated. A report of the *Gezondheidsraad* mentions a
0.0025% risk of perforation after screening for cancer in healthy subjects.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
No gastrointestinal complaints
Age between 18 - 40 years and 65 - 75 years
BMI between 20 and 30 kg/m2
Exclusion criteria
Use of PPIs, NSAIDs and/or vitamin supplementation, within 14 days prior to testing
Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study in the 90 days prior to the study
Use of antibiotics in the 90 days prior to the study.
Pregnancy
Smoking
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 | NL51235.068.14 |
| Other | Volgt, registratie in clinicaltrials.gov |