Primary objectives:- Investigate whether the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria could be decreased by ingestion of 2 apples a day for a period of 6 weeks -…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
- Significant decrease in the activity of the bacterial enzyme β-glucuronidase
and the abundance of β-glucuronidase-producing bacteria
- Assessment with WMGS of the gut microbiota composition, diversity, and
functional capacity
- The frequency of the eating of two apples a day
Secondary outcome
Secondary endpoints:
- Significant increase of SCFA
- Significant change in dietary intake, medication, stool classification and
frequency, blood pressure, weight and quality of life
Background summary
Rationale:
Studies have shown that higher blood levels of estrogen are related to an
increased risk of developing breast cancer. While there are many different
factors affecting these levels, the microbiome has been linked as a key factor.
Not only the composition of the gut microbiota plays a role here, but also its
activity is of special interest. The gut microbiota for instance produces the
bacterial enzyme β-glucuronidase which has been shown to de-conjugate biliary
excreted estrogens, leading to reactivation and reabsorption of estrogens into
the bloodstream. It might be expected that this reabsorption results in
elevated blood estrogen levels. These elevated levels of estrogen have been
linked to not only development but also recurrence of breast cancer. Apples are
known for their pectin which has prebiotic properties and a potential
decreasing effect on β-glucuronidase activity. In vitro studies and animal
studies have already shown the β-glucuronidase decreasing impact of pectin. In
humans this was never examined before.
That is why this study aims to investigate whether it is possible to lower the
activity of the bacterial enzyme β-glucuronidase and the abundance of β-
glucuronidase-producing bacteria by a simple dietary intervention. This dietary
intervention consists of the ingestion of two whole apples a day, one in the
morning and one in the evening, during the period of 6 weeks.
We hypothesize to see a decrease in the activity of the bacterial enzyme β-
glucuronidase and the abundance of β-glucuronidase-producing bacteria.
Study objective
Primary objectives:
- Investigate whether the activity of the bacterial enzyme β-glucuronidase and
the abundance of β-glucuronidase-producing bacteria could be decreased by
ingestion of 2 apples a day for a period of 6 weeks
- Examine changes in gut microbiota composition, diversity, and functional
capacity
- Examine feasibility of eating 2 apples a day for a period of 6 weeks
Secondary objectives:
- Investigate whether fecal levels of short-chain fatty acids (SCFA) increase
during the intervention period
- Examine whether the impact of eating apples reaches further, we will
investigate dietary intake, medication, stool classification and frequency,
blood pressure, weight, length and quality of life before and after the
intervention
Study design
in-participant comparison, intervention study
Intervention
the eating of two apples a day during a period of 6 weeks
Study burden and risks
There are limited risks associated with participation in this research. The
risks for the participants are minimal and consists of the following:
- The ingestion of whole apples could harm the teeth
- Further participants, who have never been eating apples before, could
experience an apple allergy
The burden for the patient is minimal and consists of the following:
- The eating of the apples and add a sticker to anapple journal
- Blood pressure, length and weight measurement at home/hospital
- 2 x 15 minutes to fill in the questionnaires (at the start and end) on
quality of life and general wellbeing
- 2 x 15 minutes to fill in the food diary and stool scale
- 2x collection of fecal sample with a patient-friendly collection kit (already
successfully applied in other studies)
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Age 50-64
Postmenopausal women
Recent negative breast cancer screening (< 6 months)
Exclusion criteria
Previous gastrointestinal surgery (excl. appendix surgery)
any type of cancer in history, except for basal cell carcinoma (BCC)
inflammatory bowel disease
mammography older than 6 months
antibiotic use within three months before fecal sampling
physically or mentally incapable or incompetent to sign informed consent
known apple allergy or complaints matching with apple allergy
less good dental state
the regularly consumption of 1 or more apples a day
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 | NL82475.068.22 |