The aim of this study is to investigate the effect of citrus extract supplementation on markers for gastrointestinal health.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the evaluation of intestinal
inflammation, measured by levels of fecal calprotectin
Secondary outcome
Secondary endpoints entail the evaluation of daily administration of citrus
extract on metabolic activity (fecal markers), microbiota composition and
functional capacity (fecal markers), immune system performance (blood markers),
gastrointestinal symptoms (questionnaires), and oxidative stress markers (blood
markers).
Background summary
Flavonoids are polyphenolic compounds with diverse beneficial biochemical
effects, including anti-oxidative and immune-modulating activities that can
affect intestinal inflammation. Furthermore, they can affect the microbiota
composition and activity. Low-grade intestinal inflammation is thought to play
a role in the pathophysiology of irritable bowel syndrome (IBS), and is
reported in a subgroup of IBS patients. Administration of the flavonoid
hesperidin to these patients might decrease intestinal inflammation and
disease-related symptoms.
Study objective
The aim of this study is to investigate the effect of citrus extract
supplementation on markers for gastrointestinal health.
Study design
This is a randomized, parallel, double-blind, placebo-controlled trial
Intervention
Participants will receive a daily dose of citrus extract or placebo for a
period of 8 weeks. Two capsules of citrus extract or placebo have to be
ingested every day before the first meal with a glass of water.
Study burden and risks
There are different burdens volunteers can experience during the study. Burdens
that volunteers can experience are the time spend on the study (subjects will
have to invest approximately 6 hours in the study). Subjects will have to take
citrus extract or placebo supplements once daily for a period of 8 weeks; the
supplements are safe for human use. They have to follow a dietary and healthy
regimen, and cannot use alcohol and abstain from physical exercise prior to the
test days. Also, they will have to discuss their medical history with the
investigator, fill in several questionnaires and a maximum total of 84 mL blood
will be sampled during the three study visits by venipuncture. This may lead to
minor discomfort and can cause small and transitory hematoma/bruises to appear.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Patients with IBS, Calprotectin levels 15-150 µg/g feces, Age 18-70 years, BMI
< 35 kg/m2
Exclusion criteria
* Comorbidities that may influence gut microbiota composition or which might
limit participation in or completion of the study protocol (to be decided by
the principle investigator)
* Abdominal surgery interfering with gastrointestinal function (to be decided
by the principle investigator)
* Use of immunosuppressive drugs within 3 months before study period
* Use of other medication interfering with endpoints
* Changes in medication that may significantly affect the study outcome
according to the investigator*s judgment within 1 month prior to the study
* Changes in clinical activity scores within 3 weeks prior to the study
* Administration of investigational drugs or participation in any scientific
intervention study which may interfere with this study (to be decided by the
principle investigator) in the 180 days prior to the study
* Use of dietary supplements containing antioxidants, minerals and vitamins
* Excessive intake of foods with a high polyphenol concentration
* Use of antibiotics within 3 months prior to the start of study
* Use of pre-or probiotics within 1 month prior to the study
* Use of oral corticosteroids within 1 month prior to the study
* Blood donation within 1 month prior to the study
* Known pregnancy or lactation.
* Excessive drinking (>20 alcoholic consumptions per week)
* History of any side effects towards the intake of flavonoids or citrus fruits
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 | NL60605.068.17 |
| Other | volgt, registratie bij clinicaltrials.gov |